Manufacturing Engineer jobs at Intuitive Surgical - 23 jobs

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you. Rx Savings Solutions (RxSS), part of McKesson's CoverMyMeds business segment, is seeking a talented Site Reliability Engineer (SRE) to join our team! In this role, you will be instrumental in ensuring the reliability, scalability, and performance of our critical healthcare technology systems. You will apply software engineering principles to operations, focusing on automation, monitoring, and proactive problem-solving to maintain high availability and deliver exceptional user experiences. * Our preferred candidate will reside in Columbus, OH, or one of our other hub locations of Overland Park KS, Irving TX or Atlanta GA. Position allows for primarily working from home, with occasional in-office time. We may consider a well-qualified candidate based not located in one of the above hub areas. * At this time, we are not able to offer sponsorship for employment visas. We're unable to consider individuals currently on H1B, F-1 OPT, STEM OPT, or any other visa status that would require future sponsorship. Candidates must be authorized to work in the United States on a permanent basis without the need for current or future sponsorship. Job Responsibilities: * System Reliability & Performance: Design, implement, and maintain robust and scalable infrastructure and applications to ensure high availability, performance, and disaster recovery capabilities * Automation & Tooling: Develop and implement automation scripts, tools, and processes to streamline operational tasks, reduce manual effort, and improve efficiency across the software development lifecycle * Monitoring & Alerting: Establish and maintain comprehensive monitoring, alerting, and logging systems to proactively identify and diagnose issues, understand system behavior, and track key performance indicators * Incident Response & Post-Mortem: Participate in on-call rotations, respond to and resolve critical incidents, and conduct thorough post-mortems to identify root causes and implement preventative measures * Capacity Planning & Optimization: Collaborate with development teams to analyze system capacity, forecast future needs, and optimize resource utilization to support business growth * Collaboration & Mentorship: Work closely with software engineers, product managers, and other SREs to promote a culture of reliability, share best practices, and contribute to continuous improvement * Documentation: Create and maintain clear and concise documentation for systems, processes, and incident runbooks * Security: Contribute to the implementation and enforcement of security best practices within our infrastructure and applications Job Qualifications: * Education / Experience: Bachelor's degree in Computer Science, Engineering, or a related field (or equivalent practical experience, and 2+ years of experience in a Site Reliability Engineering, DevOps, or highly related software engineering role * Programming Skills: Strong proficiency in at least one scripting language (e.g., Python, Go, Ruby, Bash) for automation and tool development * Cloud Platforms: Hands-on experience with cloud computing platforms (e.g., AWS, Azure, GCP). AWS experience is highly preferred * Containerization & Orchestration: Experience with container technologies (e.g., Docker) and container orchestration platforms (e.g., Kubernetes) * CI/CD: Familiarity with Continuous Integration and Continuous Delivery (CI/CD) pipelines and tools * Monitoring & Alerting Tools: Experience with monitoring and observability tools (e.g., Datadog, Prometheus, Grafana, Splunk) * Operating Systems: Strong understanding of Linux/Unix operating systems * Networking: Fundamental understanding of networking concepts (TCP/IP, DNS, HTTP, Load Balancing) * Problem-Solving: Excellent analytical and problem-solving skills with a proactive approach to identifying and resolving complex technical issues * Communication: Strong verbal and written communication skills, with the ability to articulate complex technical concepts to both technical and non-technical audiences We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here. Our Base Pay Range for this position $84,300 - $140,500 McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. Join us at McKesson!

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher's (*********************************** 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results. We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow. Learn about the Danaher Business System (************************************************************ which makes everything possible. As a Mechanical Engineer I at Beckman Coulter Life Sciences, you will design, test, and sustain advanced analytical systems by working hands‑on with multidisciplinary teams-mechanical, electrical, optical, fluidic, software, and scientific-to build instruments that accelerate biologic drug development. This is a full‑lifecycle, sleeves‑rolled‑up role: you'll prototype and iterate on concepts, analyze and test system‑level performance, collaborate with software and scientists to ensure seamless system behavior, and thoroughly document your designs and results. CAD work will ebb and flow with project needs, and you'll be supported by experienced senior engineers who will mentor you as you take on increasingly complex challenges. This position reports to the Senior Manager of Product Development for Cell Health R&D Hardware based in Loveland, Colorado and is part of the larger Global Cell Health and Centrifuge R&D team. The role is fully on‑site in Loveland, Colorado. In this role, you will have the opportunity to: + Design, build, and test opto‑electro‑mechanical systems to meet performance, reliability, and product requirements. + Collaborate hands‑on across mechanical, electrical, optical, fluidic, software, and scientific disciplines to develop and sustain life‑science instrumentation. + Prototype, iterate, and conduct system‑level testing to evaluate performance, troubleshoot issues, and refine designs. + Develop and execute component‑ and system‑level test methods, documenting results and engineering decisions to support development, manufacturing, and field service. + Participate in design reviews and support fielded products, driving continuous improvement while ensuring long‑term safety, reliability, and customer satisfaction. The essential requirements of the job include: + BS in Mechanical Engineering or an equivalent combination of education and experience. + Ability to work independently and in cross‑functional teams in a hands‑on R&D environment. + Experience with CAD modeling, mechanical drawings, and tolerancing for design and documentation. + Hands on experience building, testing, and troubleshooting physical systems It would be a plus if you also possess previous experience in: + SolidWorks for part, assembly, and drawing creation. + ASME GD&T standards for precision mechanical design. + Machining, bench‑level fabrication, or rapid 3D prototyping to support quick iterations. Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (**************************************************************************************** . At Beckman Coulter Life Sciences we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide. The annual salary range OR the hourly range for this role is 75-85k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit *************** . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here (********************************************************************************************** . We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:************** or applyassistance@danaher.com .

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results. We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow. Learn about the Danaher Business System which makes everything possible. As a Mechanical Engineer I at Beckman Coulter Life Sciences, you will design, test, and sustain advanced analytical systems by working hands‑on with multidisciplinary teams-mechanical, electrical, optical, fluidic, software, and scientific-to build instruments that accelerate biologic drug development. This is a full‑lifecycle, sleeves‑rolled‑up role: you'll prototype and iterate on concepts, analyze and test system‑level performance, collaborate with software and scientists to ensure seamless system behavior, and thoroughly document your designs and results. CAD work will ebb and flow with project needs, and you'll be supported by experienced senior engineers who will mentor you as you take on increasingly complex challenges. This position reports to the Senior Manager of Product Development for Cell Health R&D Hardware based in Loveland, Colorado and is part of the larger Global Cell Health and Centrifuge R&D team. The role is fully on‑site in Loveland, Colorado. In this role, you will have the opportunity to: Design, build, and test opto‑electro‑mechanical systems to meet performance, reliability, and product requirements. Collaborate hands‑on across mechanical, electrical, optical, fluidic, software, and scientific disciplines to develop and sustain life‑science instrumentation. Prototype, iterate, and conduct system‑level testing to evaluate performance, troubleshoot issues, and refine designs. Develop and execute component‑ and system‑level test methods, documenting results and engineering decisions to support development, manufacturing, and field service. Participate in design reviews and support fielded products, driving continuous improvement while ensuring long‑term safety, reliability, and customer satisfaction. The essential requirements of the job include: BS in Mechanical Engineering or an equivalent combination of education and experience. Ability to work independently and in cross‑functional teams in a hands‑on R&D environment. Experience with CAD modeling, mechanical drawings, and tolerancing for design and documentation. Hands on experience building, testing, and troubleshooting physical systems It would be a plus if you also possess previous experience in: SolidWorks for part, assembly, and drawing creation. ASME GD&T standards for precision mechanical design. Machining, bench‑level fabrication, or rapid 3D prototyping to support quick iterations. Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. At Beckman Coulter Life Sciences we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide. The annual salary range OR the hourly range for this role is 75-85k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit **************** Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:************** or applyassistance@danaher.com.

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Manufacturing Manager** **What you will do** Let's do this. Let's change the world. In this role you will be managing and leading all aspects of either a small manufacturing production area, or a section of a larger production area in a Packaging facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed in a shift. **Specific responsibilities include but are not limited to:** Compliance: + Evaluate and approve reports and protocols. + Ensure cGMP and CFR compliance of operating areas. + Revise, update, and review procedures + Manage the development and revision of SOPs. + Evaluate current operating procedures and recommend changes to management to optimize production. + Assure all corporate change control procedures are followed, and Regulatory and QA are made aware prior to the changes. + Interact with the FDA. + Ensure Amgen policies are followed **Process/Equipment/Facilities:** + Ensure maintenance and re validation of systems. + Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities. + Develop, implement and assess solutions for problems. + Responsible for resolving problems during operation. + Coordinates set up of critical new manufacturing processes. **Staff Supervision** + Responsible for selection, training, evaluation, staff relations and development of staff. + Ensure training programs are maintained + Ensure scheduling of production and maintenance activities. + Interacts with management in optimizing organizational structure and responsibilities + Ensure plant safety through auditing and evaluations. **Administrative:** + Interacts with management in planning, developing and maintaining budget. + Assist in developing and maintaining department goals **What we expect of you** We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications. **Basic Qualifications:** Doctorate degree **Or** Master's degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry **Or** Bachelor's degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry. **Or** Associate's degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry. **Or** High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry. In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above **Preferred Qualifications:** + Educational background in Science, Engineering or Business Administration + Availability to work on a 12-hour PM shift + Strong Managerial skills + Non-Conformance and CAPA + Ensure that all Non-conformance are triage within the established goal. + Leadership and team building + Verbal communication + Written Communication including technical writing skills + Conflict Resolution + Analytical Problem Solving + Project Management + Coaching, Mentoring and Counseling + Ability to be flexible and manage change + Regulatory requirements + Scheduling + Presentation Skills **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are seeking a Senior Process Engineer to support the design, improvement, and implementation of manufacturing processes and equipment within biotechnology production environments. In this role, you will contribute to process development, scale‑up, technology transfer, equipment integration, and ongoing operational support. You will work closely with cross‑functional teams to ensure that processes are reliable, efficient, compliant, and aligned with business and production goals. Support the design, optimization, and implementation of bioprocessing operations and manufacturing systems. Execute and support activities on filling/packaging lines, including process monitoring, issue troubleshooting, and performance optimization. Analyze process performance and identify opportunities to improve consistency, efficiency, and product quality. Collaborate with Manufacturing, Engineering, Quality, Validation, and R&D to enable efficient process transfer and operational readiness. Develop and maintain engineering documentation, including process descriptions, flow diagrams, specifications, and technical reports. Assist with equipment selection, procurement, installation, commissioning, and lifecycle management. Troubleshoot process or equipment issues to minimize downtime and maintain compliance. Ensure all processes align with applicable regulatory and quality standards, including cGMP expectations. Participate in continuous improvement activities focused on safety, productivity, and process robustness. Write and execute technical reports, including process evaluations, deviations, investigations, and equipment‑related documentation. Perform additional engineering‑related duties as assigned. Requirements Bachelor's degree in Engineering or a related scientific/technical field. 10+ years of experience in process engineering or related roles within the biotech, biopharmaceutical, or pharmaceutical manufacturing sector. Advanced knowledge of filling line operations. Strong understanding of bioprocessing concepts and manufacturing operations in regulated environments. Familiarity with engineering documentation, process analysis, and equipment implementation. Working knowledge of regulatory and quality frameworks such as cGMP and related guidelines. Experience with process equipment, automation concepts, or manufacturing support. Strong technical writing skills-ability to write and execute reports, protocols, and documentation. Strong problem‑solving, communication, and project coordination skills. Ability to work independently and collaboratively within cross‑functional teams. High attention to detail and commitment to safety, quality, and compliance. Willingness to travel as needed to support client sites and project assignments nationwide. Must be authorized to work in the U.S. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Equal Opportunity Employment Statement: PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state, and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI -RT1

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are seeking a Senior Process Engineer to support the design, improvement, and implementation of manufacturing processes and equipment within biotechnology production environments. In this role, you will contribute to process development, scale‑up, technology transfer, equipment integration, and ongoing operational support. You will work closely with cross‑functional teams to ensure that processes are reliable, efficient, compliant, and aligned with business and production goals. Support the design, optimization, and implementation of bioprocessing operations and manufacturing systems. Execute and support activities on filling/packaging lines, including process monitoring, issue troubleshooting, and performance optimization. Analyze process performance and identify opportunities to improve consistency, efficiency, and product quality. Collaborate with Manufacturing, Engineering, Quality, Validation, and R&D to enable efficient process transfer and operational readiness. Develop and maintain engineering documentation, including process descriptions, flow diagrams, specifications, and technical reports. Assist with equipment selection, procurement, installation, commissioning, and lifecycle management. Troubleshoot process or equipment issues to minimize downtime and maintain compliance. Ensure all processes align with applicable regulatory and quality standards, including cGMP expectations. Participate in continuous improvement activities focused on safety, productivity, and process robustness. Write and execute technical reports, including process evaluations, deviations, investigations, and equipment‑related documentation. Perform additional engineering‑related duties as assigned. Requirements Bachelor's degree in Engineering or a related scientific/technical field. 10+ years of experience in process engineering or related roles within the biotech, biopharmaceutical, or pharmaceutical manufacturing sector. Advanced knowledge of filling line operations. Strong understanding of bioprocessing concepts and manufacturing operations in regulated environments. Familiarity with engineering documentation, process analysis, and equipment implementation. Working knowledge of regulatory and quality frameworks such as cGMP and related guidelines. Experience with process equipment, automation concepts, or manufacturing support. Strong technical writing skills-ability to write and execute reports, protocols, and documentation. Strong problem‑solving, communication, and project coordination skills. Ability to work independently and collaboratively within cross‑functional teams. High attention to detail and commitment to safety, quality, and compliance. Willingness to travel as needed to support client sites and project assignments nationwide. Must be authorized to work in the U.S. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Equal Opportunity Employment Statement: PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state, and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RT1

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **System Owner Manufacturing Systems Engineer** **What you will do** Let's do this. Let's change the world. At Amgen, we are committed to advancing science through continuous learning, innovation, and inclusion. In this role, you'll apply advanced engineering principles to design, implement, and optimize complex automation systems supporting our innovative assembly and packaging operations. You will be part of a diverse, dynamic team responsible for developing automation strategies that ensure safety, quality, and efficiency across multiple packaging lines and systems. **Key Responsibilities** **System Design, Ownership, and Development** + Design, develop, implement, and sustain automation, control, and mechanical systems supporting packaging and manufacturing operations. + Serve as System Owner for assigned equipment and systems, accountable for system performance, reliability, lifecycle management, and regulatory compliance. + Apply established engineering principles and Amgen standards to system design, configuration, modification, and continuous improvement activities. + Develop, review, and approve system documentation including URS, specifications, design documents, SOPs, and lifecycle records. + Provide technical requirements and direction to vendors, service providers, and internal partners. **Integration, Optimization, and Operations Engineering** + Integrate new automation technologies into existing manufacturing and packaging systems. + Support process characterization, optimization, and performance monitoring to improve throughput, quality, and operational efficiency. + Act as a technical authority (SME) for assigned systems, supporting routine operations and issue resolution. + Conduct feasibility assessments, risk evaluations, and cost-benefit analyses for system enhancements. **Troubleshooting and Technical Support** + Provide advanced trouble shooting and problem-solving support for automation systems and equipment. + Collaborate with Maintenance, Automation Technicians, Manufacturing, IS, and Quality to resolve issues and minimize downtime. + Lead root cause investigations and support development and implementation of corrective and preventive actions. + Plan and execute system upgrades, obsolescence mitigation, and reliability improvements. **Compliance, Validation, and Quality Assurance** + Ensure systems operate in compliance with GMP, GAMP, data integrity, and regulatory requirements. + Support validation lifecycle activities including protocol development, execution, and reporting (IQ, OQ, PQ). + Maintain validated state of assigned systems and support regulatory inspections and audits. + Partner with Quality, Validation, and Regulatory Affairs to address compliance-related issues. **Project Management and Design Engineering** + Lead or support automation-related capital and expense projects in alignment with site and network priorities. + Coordinate with project managers, vendors, and engineering firms to deliver solutions within defined scope, schedule, and budget. + Develop technical assessments, cost estimates, schedules, and project documentation. + Communicate project status, risks, and performance metrics to stakeholders. + Reverse engineer equipment and parts **Training, Leadership, and Production Support** + Provide technical guidance, coaching, and knowledge transfer to operations and maintenance personnel. + Develop and deliver training materials to support effective operation and maintenance of systems. + Support commercial packaging operations by providing timely technical support and driving continuous improvement initiatives. + Demonstrate Amgen leadership behaviors through collaboration, accountability, and continuous learning. **Advanced Manufacturing, Reverse Engineering, and Additive Manufacturing (3-D Scanning and Printing)** + Lead and execute reverse engineering activities including dimensional analysis, material identification, functional assessment, and design recreation using CAD, 3-D scanning technologies, and engineering analysis tools. + Develop, review, and approve engineering models, drawings, and specifications for reverse-engineered parts in accordance with Amgen engineering standards and GMP requirements. + Maintain reliability of additive manufacturing (3-D printing) for spare parts, fixtures, tooling, and non-product contact components, including risk, material compatibility, mechanical performance, and regulatory impact. + Establish and maintain documentation required to support 3-D printed parts, including design records, material certifications, inspection results, and traceability documentation. + Develop lifecycle strategies for digitally stored spare parts (digital inventory), including version control, cybersecurity considerations, and long-term accessibility. + Provide technical guidance and training to Engineering, Maintenance, and Operations teams on reverse engineering methods, 3-D scanning technologies, and additive manufacturing standard methodologies. **Own the end-to-end 3-D printing process for approved use cases, including:** + Functional equivalency + Technology and material selection + Printer and scanner qualification and maintenance + Print parameter definition and optimization + Post-processing, inspection, and acceptance criteria **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The System Owner we seek will possess these qualifications. **Basic Qualifications:** Master's degree Or Bachelor's degree and 2 years of relevant Automation, Packaging, or Manufacturing experience Or Associate's degree and 4 years of relevant Automation, Packaging, or Manufacturing experience Or High school diploma / GED and 8 years of relevant Automation, Packaging, or Manufacturing experience **Preferred Qualifications:** + Advanced degree in Engineering (Mechatronics, Electrical, Computer, Mechanical, or Chemical). + Experience in pharmaceutical or biotechnology manufacturing environments. + Demonstrated System Owner or technical system lead experience. + Knowledge of PLC/HMI programming and industrial automation platforms (e.g., Rockwell, Siemens). + CSWA certification for SolidWorks. Inventor and Fusion 360 proficiency + Understanding of validation, documentation, and change management in regulated environments. + Strong analytical, problem-solving, communication, and collaboration skills. + Familiarity with Operational Excellence and Lean principles. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. System Owner Manufacturing Systems EngineerWhat you will do Let's do this. Let's change the world. At Amgen, we are committed to advancing science through continuous learning, innovation, and inclusion. In this role, you'll apply advanced engineering principles to design, implement, and optimize complex automation systems supporting our innovative assembly and packaging operations. You will be part of a diverse, dynamic team responsible for developing automation strategies that ensure safety, quality, and efficiency across multiple packaging lines and systems. Key ResponsibilitiesSystem Design, Ownership, and Development Design, develop, implement, and sustain automation, control, and mechanical systems supporting packaging and manufacturing operations. Serve as System Owner for assigned equipment and systems, accountable for system performance, reliability, lifecycle management, and regulatory compliance. Apply established engineering principles and Amgen standards to system design, configuration, modification, and continuous improvement activities. Develop, review, and approve system documentation including URS, specifications, design documents, SOPs, and lifecycle records. Provide technical requirements and direction to vendors, service providers, and internal partners. Integration, Optimization, and Operations Engineering Integrate new automation technologies into existing manufacturing and packaging systems. Support process characterization, optimization, and performance monitoring to improve throughput, quality, and operational efficiency. Act as a technical authority (SME) for assigned systems, supporting routine operations and issue resolution. Conduct feasibility assessments, risk evaluations, and cost-benefit analyses for system enhancements. Troubleshooting and Technical Support Provide advanced trouble shooting and problem-solving support for automation systems and equipment. Collaborate with Maintenance, Automation Technicians, Manufacturing, IS, and Quality to resolve issues and minimize downtime. Lead root cause investigations and support development and implementation of corrective and preventive actions. Plan and execute system upgrades, obsolescence mitigation, and reliability improvements. Compliance, Validation, and Quality Assurance Ensure systems operate in compliance with GMP, GAMP, data integrity, and regulatory requirements. Support validation lifecycle activities including protocol development, execution, and reporting (IQ, OQ, PQ). Maintain validated state of assigned systems and support regulatory inspections and audits. Partner with Quality, Validation, and Regulatory Affairs to address compliance-related issues. Project Management and Design Engineering Lead or support automation-related capital and expense projects in alignment with site and network priorities. Coordinate with project managers, vendors, and engineering firms to deliver solutions within defined scope, schedule, and budget. Develop technical assessments, cost estimates, schedules, and project documentation. Communicate project status, risks, and performance metrics to stakeholders. Reverse engineer equipment and parts Training, Leadership, and Production Support Provide technical guidance, coaching, and knowledge transfer to operations and maintenance personnel. Develop and deliver training materials to support effective operation and maintenance of systems. Support commercial packaging operations by providing timely technical support and driving continuous improvement initiatives. Demonstrate Amgen leadership behaviors through collaboration, accountability, and continuous learning. Advanced Manufacturing, Reverse Engineering, and Additive Manufacturing (3-D Scanning and Printing) Lead and execute reverse engineering activities including dimensional analysis, material identification, functional assessment, and design recreation using CAD, 3-D scanning technologies, and engineering analysis tools. Develop, review, and approve engineering models, drawings, and specifications for reverse-engineered parts in accordance with Amgen engineering standards and GMP requirements. Maintain reliability of additive manufacturing (3-D printing) for spare parts, fixtures, tooling, and non-product contact components, including risk, material compatibility, mechanical performance, and regulatory impact. Establish and maintain documentation required to support 3-D printed parts, including design records, material certifications, inspection results, and traceability documentation. Develop lifecycle strategies for digitally stored spare parts (digital inventory), including version control, cybersecurity considerations, and long-term accessibility. Provide technical guidance and training to Engineering, Maintenance, and Operations teams on reverse engineering methods, 3-D scanning technologies, and additive manufacturing standard methodologies. Own the end-to-end 3-D printing process for approved use cases, including: Functional equivalency Technology and material selection Printer and scanner qualification and maintenance Print parameter definition and optimization Post-processing, inspection, and acceptance criteria What we expect of you We are all different, yet we all use our unique contributions to serve patients. The System Owner we seek will possess these qualifications. Basic Qualifications: Master's degree Or Bachelor's degree and 2 years of relevant Automation, Packaging, or Manufacturing experience Or Associate's degree and 4 years of relevant Automation, Packaging, or Manufacturing experience Or High school diploma / GED and 8 years of relevant Automation, Packaging, or Manufacturing experience Preferred Qualifications: Advanced degree in Engineering (Mechatronics, Electrical, Computer, Mechanical, or Chemical). Experience in pharmaceutical or biotechnology manufacturing environments. Demonstrated System Owner or technical system lead experience. Knowledge of PLC/HMI programming and industrial automation platforms (e.g., Rockwell, Siemens). CSWA certification for SolidWorks. Inventor and Fusion 360 proficiency Understanding of validation, documentation, and change management in regulated environments. Strong analytical, problem-solving, communication, and collaboration skills. Familiarity with Operational Excellence and Lean principles. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 118,497.00 USD - 134,250.00 USD

**ABOUT THE ROLE** **Role Description:** We are seeking a **Sr Machine Learning Engineer** -Amgen's senior individual-contributor authority on building and scaling end-to-end machine-learning and generative-AI platforms. Sitting at the intersection of engineering excellence and data-science enablement, you will design the core services, infrastructure and governance controls that allow hundreds of practitioners to prototype, deploy and monitor models-classical ML, deep learning and LLMs-securely and cost-effectively. Acting as a "player-coach," you will establish platform strategy, define technical standards, and partner with DevOps, Security, Compliance and Product teams to deliver a frictionless, enterprise-grade AI developer experience. **Roles & Responsibilities:** + **Engineer end-to-end ML pipelines** -data ingestion, feature engineering, training, hyper-parameter optimization, evaluation, registration and automated promotion-using Kubeflow, SageMaker Pipelines, Open AI SDK or equivalent MLOps stacks. + **Harden research code into production-grade micro-services** , packaging models in Docker/Kubernetes and exposing secure REST, gRPC or event-driven APIs for consumption by downstream applications. + **Build and maintain full-stack AI applications** by integrating model services with lightweight UI components, workflow engines or business-logic layers so insights reach users with sub-second latency. + **Optimize performance and cost at scale** -selecting appropriate algorithms (gradient-boosted trees, transformers, time-series models, classical statistics), applying quantization/pruning, and tuning GPU/CPU auto-scaling policies to meet strict SLA targets. + **Instrument comprehensive observability** -real-time metrics, distributed tracing, drift & bias detection and user-behavior analytics-enabling rapid diagnosis and continuous improvement of live models and applications. + **Embed security and responsible-AI controls** (data encryption, access policies, lineage tracking, explainability and bias monitoring) in partnership with Security, Privacy and Compliance teams. + **Contribute reusable platform components** -feature stores, model registries, experiment-tracking libraries-and evangelize best practices that raise engineering velocity across squads. + **Perform exploratory data analysis and feature ideation** on complex, high-dimensional datasets to inform algorithm selection and ensure model robustness. + **Partner with data scientists to prototype and benchmark new algorithms** , offering guidance on scalability trade-offs and production-readiness while co-owning model-performance KPIs. **Must-Have** **Skills:** + **3-5 years** in AI/ML and enterprise software. + **Comprehensive command of machine-learning algorithms** **-** regression, tree-based ensembles, clustering, dimensionality reduction, time-series models, deep-learning architectures (CNNs, RNNs, transformers) and modern LLM/RAG techniques-with the judgment to choose, tune and operationalize the right method for a given business problem. + Proven track record selecting and integrating AI SaaS/PaaS offerings **and** building custom ML services at scale. + Expert knowledge of GenAI tooling: vector databases, RAG pipelines, prompt-engineering DSLs and agent frameworks (e.g., LangChain, Semantic Kernel). + Proficiency in Python and Java; containerization (Docker/K8s); cloud (AWS, Azure or GCP) and modern DevOps/MLOps (GitHub Actions, Bedrock/SageMaker Pipelines). + Strong business-case skills-able to model TCO vs. NPV and present trade-offs to executives. + Exceptional stakeholder management; can translate complex technical concepts into concise, outcome-oriented narratives. **Good-to-Have Skills:** + Experience in Biotechnology or pharma industry is a big plus + Published thought-leadership or conference talks on enterprise GenAI adoption. + Master's degree in computer science and or Data Science + Familiarity with Agile methodologies and Scaled Agile Framework (SAFe) for project delivery. **Education and Professional Certifications** + Master's degree with 8 + years of experience in Computer Science, IT or related field OR + Bachelor's degree with 10 + years of experience in Computer Science, IT or related field + Certifications on GenAI/ML platforms (AWS AI, Azure AI Engineer, Google Cloud ML, etc.) are a plus. **Soft Skills:** + Excellent analytical and troubleshooting skills. + Strong verbal and written communication skills + Ability to work effectively with global, virtual teams + High degree of initiative and self-motivation. + Ability to manage multiple priorities successfully. + Team-oriented, with a focus on achieving team goals. + Ability to learn quickly, be organized and detail oriented. + Strong presentation and public speaking skills.

ABOUT THE ROLE Role Description: We are seeking a Sr Machine Learning Engineer-Amgen's senior individual-contributor authority on building and scaling end-to-end machine-learning and generative-AI platforms. Sitting at the intersection of engineering excellence and data-science enablement, you will design the core services, infrastructure and governance controls that allow hundreds of practitioners to prototype, deploy and monitor models-classical ML, deep learning and LLMs-securely and cost-effectively. Acting as a "player-coach," you will establish platform strategy, define technical standards, and partner with DevOps, Security, Compliance and Product teams to deliver a frictionless, enterprise-grade AI developer experience. Roles & Responsibilities: * Engineer end-to-end ML pipelines-data ingestion, feature engineering, training, hyper-parameter optimization, evaluation, registration and automated promotion-using Kubeflow, SageMaker Pipelines, Open AI SDK or equivalent MLOps stacks. * Harden research code into production-grade micro-services, packaging models in Docker/Kubernetes and exposing secure REST, gRPC or event-driven APIs for consumption by downstream applications. * Build and maintain full-stack AI applications by integrating model services with lightweight UI components, workflow engines or business-logic layers so insights reach users with sub-second latency. * Optimize performance and cost at scale-selecting appropriate algorithms (gradient-boosted trees, transformers, time-series models, classical statistics), applying quantization/pruning, and tuning GPU/CPU auto-scaling policies to meet strict SLA targets. * Instrument comprehensive observability-real-time metrics, distributed tracing, drift & bias detection and user-behavior analytics-enabling rapid diagnosis and continuous improvement of live models and applications. * Embed security and responsible-AI controls (data encryption, access policies, lineage tracking, explainability and bias monitoring) in partnership with Security, Privacy and Compliance teams. * Contribute reusable platform components-feature stores, model registries, experiment-tracking libraries-and evangelize best practices that raise engineering velocity across squads. * Perform exploratory data analysis and feature ideation on complex, high-dimensional datasets to inform algorithm selection and ensure model robustness. * Partner with data scientists to prototype and benchmark new algorithms, offering guidance on scalability trade-offs and production-readiness while co-owning model-performance KPIs. Must-Have Skills: * 3-5 years in AI/ML and enterprise software. * Comprehensive command of machine-learning algorithms-regression, tree-based ensembles, clustering, dimensionality reduction, time-series models, deep-learning architectures (CNNs, RNNs, transformers) and modern LLM/RAG techniques-with the judgment to choose, tune and operationalize the right method for a given business problem. * Proven track record selecting and integrating AI SaaS/PaaS offerings and building custom ML services at scale. * Expert knowledge of GenAI tooling: vector databases, RAG pipelines, prompt-engineering DSLs and agent frameworks (e.g., LangChain, Semantic Kernel). * Proficiency in Python and Java; containerization (Docker/K8s); cloud (AWS, Azure or GCP) and modern DevOps/MLOps (GitHub Actions, Bedrock/SageMaker Pipelines). * Strong business-case skills-able to model TCO vs. NPV and present trade-offs to executives. * Exceptional stakeholder management; can translate complex technical concepts into concise, outcome-oriented narratives. Good-to-Have Skills: * Experience in Biotechnology or pharma industry is a big plus * Published thought-leadership or conference talks on enterprise GenAI adoption. * Master's degree in computer science and or Data Science * Familiarity with Agile methodologies and Scaled Agile Framework (SAFe) for project delivery. Education and Professional Certifications * Master's degree with 8 + years of experience in Computer Science, IT or related field OR * Bachelor's degree with 10 + years of experience in Computer Science, IT or related field * Certifications on GenAI/ML platforms (AWS AI, Azure AI Engineer, Google Cloud ML, etc.) are a plus. Soft Skills: * Excellent analytical and troubleshooting skills. * Strong verbal and written communication skills * Ability to work effectively with global, virtual teams * High degree of initiative and self-motivation. * Ability to manage multiple priorities successfully. * Team-oriented, with a focus on achieving team goals. * Ability to learn quickly, be organized and detail oriented. * Strong presentation and public speaking skills. . Salary Range 164,029.00 USD - 209,103.00 USD

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America, San Jose, California, United States of America Job Description: Johnson & Johnson's Family of Companies is recruiting for an Associate External Manufacturing Engineer, within our Robotics and Digital (RAD) Solutions organization, supporting Flexible Robotics (MONARCH)! About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech At Johnson & Johnson Robotics and Digital Solutions, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH), Surgical Robotics (OTTAVA), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes. Position Overview: The best Manufacturing Engineers at J&J are dedicated, adaptable and well versed in overall product development activities. They work closely with R&D, Quality, Manufacturing, Program Management, Supply Chain, Marketing, and Regulatory in coordinating all aspects of Process Design, Development, Optimization, Validation, and Improvement throughout its lifecycle. Their greatest forte is influencing key engineering decisions with the right data resulting in a highly scalable and manufacturable product on day one of commercial launch. They are also adept at making trade-off decisions on product performance, design, process capability and final manufacturing outputs. Key Responsibilities: * Assist in end-to-end process solution deployment, from feasibility to verification/validation, including creating fixturing/tooling for Instrument Manufacturing & Assembly processes (catheter and other devices). * Cross-functional collaboration and deployment of automation solutions to stream-line various processes: including, but not limited to lamination, braiding, tipping, soldering, final inspection, and pouching/boxing/label printing processes. * Document and execute equipment/process validation protocols & reports. * Study existing processes to implement improvements on new products. Qualifications Required: * A minimum of a Bachelors degree in an Engineering discipline. * Professional experience outside of degree program. * Knowledge of good manufacturing practices and documentation. * Excellent written and oral communication skills. * Experience in a regulated industry; medical device experience is a plus. * Knowledge of computer programs in addition to Microsoft office products. * Self-starter with a desire to engage in proactive learning and remain productive with supervision from more senior engineers. * Must be highly organized with the ability to drive projects/tasks simultaneously and effectively prioritize projects and tasks * Experience in process/product validations. Preferred: * A degree in Mechanical, Biomedical, or Industrial Engineering * Background in various catheter manufacturing related processes such as Braiding, Lamination, Soldering, Adhesive Bonding, Tipping, etc. * Experience with commercial or pilot manufacturing lines & technical report writing. * Familiarized with manufacturing processes equipment, such as ultrasonic welders, leak testers, pouch sealers, etc. * Knowledge of a combination of process engineering tools such as DOE's, Statistical Methods, CAD (Solid-works/Pro-E/AutoCAD), GD&T, Process Simulation, Failure Analysis Techniques (Fault tree, Fish Bone Diagram). Other: * Ability to travel up to 20%, international and domestic * Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. * For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ******************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Accelerating, Communication, Detail-Oriented, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Management Tools, Project Support, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy The anticipated base pay range for this position is : $65,000.00 - $104,650.00 For Bay Area: $75,000.00 - $120,750.00 Additional Description for Pay Transparency: Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role. [DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION] Please use the following language: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - https://*******************/employee-benefits

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: R&D Mechanical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent to join our Lifecycle (Sustaining) Engineering team as a Senior Design Engineer, LCE located in Cincinnati, OH. Purpose: As a member of the Lifecycle Engineering team, you will join us to lead projects and drive design activities for products currently in the market. You will collaborate with internal and external teams to develop and maintain advanced surgical products within our stapling portfolio and/or energy-based surgical device portfolio within R&D. What you will be responsible for: Ensure design intent is maintained throughout design and manufacturing change projects. Work both independently and within teams, and with internal & external partners to identify and evaluate potential technical solutions. Provide innovative product, system, and component design solutions to address opportunities related to quality, supply chain, regulatory compliance, and cost savings opportunities. Develop and utilize FMEA's, GD&T, tolerance analysis, FEA, DOE's, simulated use testing, and statistical analysis to support medical device/system design changes Perform detailed design analysis and provide guidance or approval for design or specification changes Establish and execute appropriate testing strategy to ensure adequate safety factors or margins Learn medical terminology, procedures & instrumentation and assist in responding to surgeon customer feedback. Provide peer feedback & mentor junior associates as required. Qualifications/Requirements: Education: A minimum of a Bachelor's Degree in Engineering (preferably mechanical or biomedical engineering) or a related science/engineering degree Required: A minimum of 6 years of experience in product design and/or sustaining engineering, maintaining product design intent after launch. Strong product design and analysis experience, including an understanding of subsystem and component contributions to overall system design and performance Experience with statistical analysis techniques Experience working in a multi-functional team environment Strong problem-solving and execution skills for developing creative solutions and meeting project objectives Ability to independently create project plans and manage multiple projects/priorities simultaneously. Excellent collaboration, strong communication, and interpersonal skills; an ability to work effectively with teams Ability to Plan, communicate, execute, analyze, & document testing, including developing and documenting new test fixtures and methods. Technical writing skills such as protocols, testing results, procedures, status & special reports Experience in Root Cause Investigation, proposing and implementing immediate corrections based on findings, and leading design or manufacturing improvement projects for long term stability. Ability to plan and lead, as well as partner with internal resources, functional groups (i.e. Marketing, Supply Chain, etc.) and external companies to complete projects. Medical Device industry experience or regulated industry experience Flexibility to reprioritize projects and activities to meet business needs. Preferred: Advanced Degree Experience with 3D CAD, design analysis software, and statistical analysis techniques Experience with FEA (Finite Element Analysis) and Geometric dimension & tolerance stack-up analysis (GD&T) Experience in tooling methodologies, material properties (Plastic resins, ferrous & nonferrous metals, adhesives & sealants). Knowledge of plastics, metals and coating properties, uses, and manufacturing processes used in the Medical Device industry. Strong understanding of design control and the ability to develop and execute design change plans and design verification testing. Experience designing, developing, and launching products. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. #LI-Onsite Required Skills: AutoCAD Engineering, Engineering Drawings, Product Engineering Preferred Skills: Analytical Reasoning, Auto-CAD Design, Business Case Modeling, Coaching, Design Thinking, Mechanical Engineering, Problem Solving, Process Oriented, Product Reliability, Project Management Methodology (PMM), Project Support, Quality Control (QC), Research and Development, Resource Allocation, SAP Product Lifecycle Management, Technical Credibility, Technologically Savvy The anticipated base pay range for this position is : $109,650 - $148,350 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. This position is overtime eligible. (include if applicable for role) This position is eligible for a shift differential. (include if applicable for role) Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. ********************************************* This job posting is anticipated to close on [January/23/2026]. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: R&D Electrical/Mechatronic Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Ethicon's Robotics & Digital Solutions business, part of Johnson & Johnson MedTech, is recruiting for an Associate R&D Mechatronic Engineer, located in Cincinnati, OH. Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH), Surgical Robotics (OTTAVA), and Digital Solutions. Join our collaborative teams in the Bay Area (Santa Clara) and Cincinnati. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes. As an Associate R&D Mechatronic Engineer, you will play a critical role in designing, developing, and optimizing test systems for cutting-edge robotic medical devices. You'll work closely with cross-functional teams to create common test platforms, analyze performance data, and ensure our devices meet rigorous standards for safety and effectiveness. Key Responsibilities: * Develop software and hardware systems and test methods to evaluate the performance of robotic instruments. * Support the design of product concepts quickly and effectively via prototype builds, laboratory testing, and/or computer simulations. * Generate, process, analyze advanced engineering data to meet design requirements. * Participate in detailed reviews of designs, test methods, requirements, and effectively communicate technical information in written/verbal forms. * Collaborate with other hardware and software engineers to align and set functional best practices for test method development. * Support effective test execution management, data collection and reporting through coordination and collaboration with existing resources. * All responsibilities listed may not be assigned and other responsibilities may be assigned. Qualifications Required Knowledge/Skills, Education, And Experience: * Bachelor of Science in Software Engineering, Mechanical Engineering, Biomedical Engineering, or related science/engineering field. * 1 year minimum of product development/ design experience. * Experience programming in Python. * Experience working in a Linux environment. * Able to assist with engineering investigations, problem solving, root cause, prototype rework, and component modification. * Effective communication, collaboration, and teaming skills with ability to present technical information to engineering team. * Data analysis experience. * Up to 10% domestic and international travel may be required, including overnight stays. * Ability to work in Cincinnati, Ohio. Preferred Knowledge/Skills, Education, And Experience: * Experience using or developing with ROS2, databases (Postgres or MySQL), and cloud platforms. * Familiarity with version control and code management tools (git, bitbucket). * Vision inspection and processing using Cognex or OpenCV. * Basic mechanical design and analysis skills, including an understanding of mechanism design and machine elements. * Able to provide positive and constructive feedback to teammates on product concepts and designs. * Organized with creative with analytical and problem-solving skills; Able to work independently under general supervision. * Able to set and prioritize goals with general guidance from management. * Experience working on a project team with demonstration of encouraging and inclusive behaviors. * Knowledge of component manufacturing processes (injection molding, machining, stamping, etc.), DFM/A, and Design to Cost. * Working knowledge of design controls, design plans, and verification/validation, preferably as they apply within a regulated industry. * Systems-based design experience, including integration of cross-disciplinary technologies (e.g., mechanical, electrical, controls, software). * Experience in the design, development, and commercialization of medical devices with an understanding of their application in surgical procedures. * Experience in the verification of medical devices according to regulatory standards, including FDA requirements. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 01/20/26. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Data Analysis, Linux Environments, Mechatronics, Python (Programming Language) Preferred Skills: Assembly Operations, Calibration Procedures, Customer Service, Electrical Engineering, Execution Focus, Goal-Oriented, Process Oriented, Project Management, Report Writing, Research and Development, Robotic Automation, SAP Product Lifecycle Management, Smart Systems, Technical Research, Technical Troubleshooting, Technical Writing, Technologically Savvy, Versatility The anticipated base pay range for this position is : The anticipated base pay range for this position is $76,000.00 to $121,900.00 Additional Description for Pay Transparency:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Product Development **Job Sub** **Function:** Biomedical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Cincinnati, Ohio, United States of America **Job Description:** Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. **Position Summary:** + This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH + This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. + Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. + Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis and provides input or approval for detailed design specifications, tooling, fabrication, and testing. + At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc. **Staff Quality Engineer** **Duties** + Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. + Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. + Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. + Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development. + Researches and compiles worldwide regulatory and technical standards for shift in design related quality trends. + Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization. + Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems. + Oversees the implementation of world with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. + Provides support to Johnson and Johnson process excellence initiatives including six sigma, design excellence, and lean thinking. + Oversees engineering operations, scientific evaluations of new products, technology concepts and development. + Purchases or designs equipment that meets health, safety and environmental standards set by the company. + Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes. + Assures compliance with all local government and company regulations, policies and procedures. + Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests. + Researches and reports on competitors' design strengths and weaknesses. + Provides technical expertise across a broad range of engineering areas and methodologies. + Leads and oversees the activities of engineers and support staff. + Responsible for communicating business related issues or opportunities to next management level. + For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. + Performs other duties assigned as needed. + May support technical training (i.e. statistics and quality methods) and teaching/mentoring of other **Required Experience and Skills:** + A minimum of 6 years of work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience + Advanced knowledge of Quality Engineering/Scientific methods and techniques + Applied statistics of growing complexity + Test method development, statistics, and reliability + Experience working within a team, acquiring feedback, negotiating, and training + Understand new concepts quickly, research and maintain ongoing learning of industry regulations + Fundamental technical understanding of manufacturing equipment and processes + Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) **Preferred Experience & Skills:** + Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications + An ASQ certification (CQE, CQM, CRE or CQA) + Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification + Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment + Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) + Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) **Other:** + **This position is located in Cincinnati, OH and has up to 10% of both domestic and international travel.** Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** $91,000-$147,200 USD$ Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. Position Summary: * This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH * This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. * Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. * Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis and provides input or approval for detailed design specifications, tooling, fabrication, and testing. * At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc. Staff Quality Engineer Duties * Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. * Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. * Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. * Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development. * Researches and compiles worldwide regulatory and technical standards for shift in design related quality trends. * Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization. * Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems. * Oversees the implementation of world with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. * Provides support to Johnson and Johnson process excellence initiatives including six sigma, design excellence, and lean thinking. * Oversees engineering operations, scientific evaluations of new products, technology concepts and development. * Purchases or designs equipment that meets health, safety and environmental standards set by the company. * Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes. * Assures compliance with all local government and company regulations, policies and procedures. * Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests. * Researches and reports on competitors' design strengths and weaknesses. * Provides technical expertise across a broad range of engineering areas and methodologies. * Leads and oversees the activities of engineers and support staff. * Responsible for communicating business related issues or opportunities to next management level. * For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. * Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. * Performs other duties assigned as needed. * May support technical training (i.e. statistics and quality methods) and teaching/mentoring of other Required Experience and Skills: * A minimum of 6 years of work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience * Advanced knowledge of Quality Engineering/Scientific methods and techniques * Applied statistics of growing complexity * Test method development, statistics, and reliability * Experience working within a team, acquiring feedback, negotiating, and training * Understand new concepts quickly, research and maintain ongoing learning of industry regulations * Fundamental technical understanding of manufacturing equipment and processes * Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) Preferred Experience & Skills: * Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications * An ASQ certification (CQE, CQM, CRE or CQA) * Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification * Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment * Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) * Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) Other: * This position is located in Cincinnati, OH and has up to 10% of both domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $91,000-$147,200 USD$ Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Engineering Job Sub Function: Packaging Design Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Entry-level role focused on learning, supporting, and executing core packaging development and validation activities under guidance, while progressively gaining technical autonomy to independently owns packaging design and validation workstreams. Key Responsibilities: * Develop packaging components by translating product requirements into appropriate designs, with progressive autonomy. * Write and execute packaging Validations and Verifications for designs and stability. * Support manufacturing, process validation, and testing; apply IQ/OQ/PQ principles. * Create packaging development timelines for NPD and/or LCM projects that integrate into larger initiatives. * Follow ISO11607, applicable ASTM and ISTA procedures to ensure compliance. * Create material and drawing documents; ensure supplier validations are performed. * Utilize SolidWorks, AutoCAD, or similar tools; apply TOPS or CAPE as needed. * Understand packaging equipment (e.g., blister sealer, F/F/S, bar sealer) and their critical inputs/outputs. * Perform gap analysis of proposed vs. current documentation; author/revise technical documentation. * Apply basic statistical knowledge for data-driven decisions. * Perform Portfolio Management tasks and maintain documentation. * Ability to collaborate with department peers and cross functions partners to communicate information. * Support dFMEA and pFMEA input and creation. * Ability to listen, learn, and retain technical information while demonstrating growing autonomy. * Performs other duties as assigned. Qualifications: * Minimum of a Bachelor's degree and/or equivalent University degree is required; focused degree in Package Engineering Degree (or degree in an engineering or scientific field e.g., Mechanical, Chemical, Biomedical Engineering) preferred. * Related work experience is required. * Experience with new product development and commercialization of products in a regulated industry as an engineer preferred. * Experience as a package development engineer or a strong understanding of the package development process and responsibilities. * Experience as a technical lead of projects. * Six Sigma Certifications preferred. * Proficiency in computers, technology including MS office applications. * Strong verbal and written communication skills to clearly convey ideas, instructions, and feedback across cross functional team. * Ability to build relationships and collaborate effectively through active listening, clear messaging, and professional presentation. * Experience working with medical device package development. * Knowledge of sterile barrier packaging systems and design verification including ASTM or ISTA test methods. * Knowledge of Package Assembly and Packaging Processes/Equipment. * Knowledge and experience with ISO11607. * Medical Device and/or Pharmaceutical industry experience. * Understanding of sterilization modes used in medical devices. * Project management skills. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $65,000.00 - $104,650.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Career Programs Job Sub Function: Non-LDP Intern/Co-Op Job Category: Career Program All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: As a Co-op in the MedTech (MT) Quality Engineering organization, you will have the chance to: * Collaborate with teams across J&J MedTech on Quality Engineering projects. * Support and/or perform risk management activities. * Learn and apply various statistical techniques to analyze data. * Develop and contribute to training materials including procedures and work instructions. * Strengthen presentation, communication, and leadership skills. * Work with a diverse team of quality, development, test, and design engineers. * Take advantage of training courses offered at J&J. * Support project teams in ensuring the product being developed is safe and effective for patient use. The Quality Engineer Co-op will: * Have the opportunity to work at and support J&J MedTech in Cincinnati, Ohio * Work in MT Quality Engineering with the chance to support various project teams. * Report directly to and receive assignments from their assignment manager while also working with the broader team for additional assignments. * Participate in and/or lead on-campus activities such as learning committees, volunteer events, and meet and greet luncheons with full time associates. Qualifications * Enrolled in an accredited College/University pursuing a Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or similar degree. * Completed at least one year of given degree at the beginning of the co-op term in May 2026 with a graduation date after August 2026. * GPA of 3.0 or above. * Authorized to work in the United States during the full duration of the co-op (05/2026 - 08/2026). * Detail-oriented, highly organized and able to manage multiple tasks. * Demonstrated ability to work independently as well as on a team. * Ability to work with other teams and individuals using virtual tools (Microsoft Teams, etc). * Proficiency with Microsoft Office (Word, Excel, Power Point) and have strong oral and written communication skills. Preferred: * Demonstrated leadership/participation in campus programs and/or community service activities. * Previous quality related experiences. * Knowledge of FDA or regulatory guidance. * Medical related experience (previous co-op at medical device company, working volunteering at a hospital, etc.). * Experience with Minitab or other statistical analysis software. Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $23.00/hr to $51.50/hr Additional Description for Pay Transparency: The expected pay range for this position is between $23.00 per hour and $51.50 per hour but will be based on candidate's program year, discipline, degree and/or experience. Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company's consolidated retirement plan (pension). For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 8/14/2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Cincinnati, Ohio, United States of America **Job Description:** **About Surgery** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **We are searching for the best talent for** **Senior Supplier Quality Engineer to be located in Cincinnati, OH.** The Supplier Quality Engineers are responsible for supplier-related quality engineering activities in support of New Product Development and ongoing manufacturing. Supplier Quality Engineers have the opportunity to support activities associated with External Manufacturers, Direct Material (Component) Suppliers, and Indirect Service Suppliers. **You will be responsible for** **:** + Issues resolution with suppliers - investigating challenging issues with significant business impact. + Developing and maintaining suppliers - executing Supplier Reviews, audit related activities and deep dive Technical Assessments at suppliers. + Development/negotiation of Quality Agreements with suppliers. + Changing the way we do business - continuously improving our policies and procedures. + Supplier process changes - assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities). + Stabilizing new products at suppliers - working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities. + The technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. + Provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product. + Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements. **Qualifications / Requirements:** + A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science , Physical Science and/or related is preferred. An advanced degree is preferred. + A minimum of 2 years Quality/Manufacturing experience or related experience is required. + Experience in the medical device, pharmaceutical or other highly regulated industry is preferred. + Knowledge of ISO and/or cGMP regulations is preferred. + Experience in a FDA regulated environment is preferred. + An ASQ certification (CQE, CQM, CRE or CQA) is preferred. + Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred. + Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred. + It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc. + Auditing experience is preferred. + Strong root cause analysis skills are required. + Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred. + This position may require up to 10% domestic travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy **The anticipated base pay range for this position is :** $79,000.00 - $127,650.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for Senior Supplier Quality Engineer to be located in Cincinnati, OH. The Supplier Quality Engineers are responsible for supplier-related quality engineering activities in support of New Product Development and ongoing manufacturing. Supplier Quality Engineers have the opportunity to support activities associated with External Manufacturers, Direct Material (Component) Suppliers, and Indirect Service Suppliers. You will be responsible for: Issues resolution with suppliers - investigating challenging issues with significant business impact. Developing and maintaining suppliers - executing Supplier Reviews, audit related activities and deep dive Technical Assessments at suppliers. Development/negotiation of Quality Agreements with suppliers. Changing the way we do business - continuously improving our policies and procedures. Supplier process changes - assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities). Stabilizing new products at suppliers - working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities. The technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. Provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product. Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements. Qualifications / Requirements: A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science , Physical Science and/or related is preferred. An advanced degree is preferred. A minimum of 2 years Quality/Manufacturing experience or related experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is preferred. Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is preferred. An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred. Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred. It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc. Auditing experience is preferred. Strong root cause analysis skills are required. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred. This position may require up to 10% domestic travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy The anticipated base pay range for this position is : $79,000.00 - $127,650.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************