Principal Engineer jobs at Johnson & Johnson - 642 jobs

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 Operations **Job Sub** **Function:** Clinical/Medical Operations **Job Category:** Professional **All Job Posting Locations:** Santa Clara, California, United States of America **Job Description:** Johnson & Johnson is hiring for a Sr. Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote with 80% travel. 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 *******************/ . Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success. **Essential Job Functions** + Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. + Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms. + Provide clinical and technical support for key study investigators and clinical leaders at assigned sites. + Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues. + Administrative activities including training to procedures at site level. + Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals. + Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools. + Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. + Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals. + Partner with assigned physician advisors to create and deliver recruitment strategies. + Partner with vendors that support recruitment activities. + Other duties as assigned. **Requirements** + Bachelor's Degree in a scientific field of study or equivalent work experience. + Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional Cardiology or surgical procedures in a cardiovascular Lab. + Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials. + Thorough knowledge of Good Clinical Practice (GCP) is required. + Ability to attain and maintain hospital credentials. + Ability to work in a fast-paced environment while managing multiple priorities. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + Experience with electronic data capture (EDC) systems. + Must have excellent verbal and written communication skills. + High attention to detail and accuracy. + Able to manage multiple project teams with guidance + Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) + Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America. + May be required to lift up to 25 pounds. 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, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Schedule, Research and Development, Study Management **The anticipated base pay range for this position is :** $106,000.00 - $170,200.00 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)). For additional general information on Company benefits, please go to: - ********************************************* 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

A pioneering neuroscience company based in Boston, MA is seeking a firmware developer to create embedded solutions for advanced brain stimulation devices. The ideal candidate will have a strong background in C programming, experience with BLE protocols, and a passion for building innovative healthcare technologies. The role offers comprehensive benefits, including health insurance and stock options. #J-18808-Ljbffr

At Nia Therapeutics, we are engineering solutions at the frontier of neuroscience to make memory loss reversible. We are a team of scientists and engineers developing advanced implantable brain stimulation devices to reverse memory loss from brain injury and degenerative disease. Our core technology, developed at the University of Pennsylvania and funded by DARPA, is built on a foundation of human clinical studies that demonstrate its efficacy. This is a rare opportunity to help develop a product that will not only improve patient lives but also redefine what's possible in neural engineering. What you will do Develop embedded firmware in C to support BLE communication between an implantable device and mobile apps Design and implement custom GATT services and characteristics to enable secure, low-latency data exchange Support real-time signal processing, sensor interfaces, and closed-loop control logic Contribute to the design of system-level communication protocols across implant, wearable, and cloud platforms Help build automated test systems for wireless and embedded functionality Required Qualifications BS in Electrical Engineering / Computer Science plus 5+ / 8+ / 11+ years experience OR an advanced degree plus 3+ / 6+ / 9+ years of experience Strong programming skills in C for embedded systems Hands-on experience developing and debugging BLE firmware, including custom profiles and characteristics Understanding of BLE stack behavior (advertising, connection parameters, bonding, encryption) Comfortable working with microcontroller toolchains, oscilloscopes, and logic analyzers Ability to read datasheets and electrical schematics and develop device drivers Strong troubleshooting, communication, and cross-functional collaboration skills Preferred Skills Experience with ST or Nordic microcontrollers RTOS based firmware development (e.g. FreeRTOS, Zephyr) Hands-on experience developing and debugging Bluetooth Low Energy (BLE) communication protocols, including creating custom GATT services and characteristics Experience integrating mobile applications with embedded firmware, ensuring robust and reliable data exchange Experience developing active implantable medical devices, medical device quality systems, standards (e.g. ISO-14708) and risk management activities (e.g. FMEA) Proficiency in cross-platform (Android, iOS) mobile application development Broad circuit design experience including analog, digital, power supply and comms functions Setting up and maintaining testing environments for hardware and software systems Our Culture This position is 5 days per week in person based in Boston, MA. We're a small team tackling big challenges. We move quickly, think rigorously, and care deeply about the impact of our work. If you're excited by the idea of helping build a product that integrates neuroscience, embedded systems, and mobile UX, and you're eager to grow in a fast-paced startup, we'd love to meet you. Benefits Nia Therapeutics provides comprehensive health benefits to support our employees' well-being, including medical, dental, and vision insurance. We also offer stock options, giving team members a direct stake in the company's success and long-term mission. #J-18808-Ljbffr

A leading biotechnology firm in California seeks an experienced professional with a Ph.D. in biochemistry or a related field, or an extensive background in protein therapeutics and antibody engineering. Candidates should have significant experience in advancing therapeutic candidates through preclinical development and be proficient in molecular biology techniques and computational design tools. Excellent collaboration and communication skills are essential for this role. #J-18808-Ljbffr

A leading biotech company in California is seeking an Associate Director of Device Engineering to oversee the lifecycle of drug-device combination products. This role involves leading cross-functional teams, managing product development, and ensuring supply chain continuity. Ideal candidates will have a doctoral degree and extensive experience in medical device commercialization. The company offers competitive compensation and a full benefits package. #J-18808-Ljbffr

About the Role Home Solutions is seeking a Vice President / Principal Software Engineer and Architect to lead the vision, architecture, and hands-on development of the critical systems that power our fast-growing business. You will be a senior technical leader within the organization - defining architecture, building modern, scalable systems, guiding engineering excellence, and solving the highest impact technical problems in our stack. This is a highly impactful role at the intersection of back-end engineering, enterprise architecture, data systems, cloud infrastructure, and AI-driven automation. Your Day-to-Day Architecture, Technical Strategy & Roadmap: Lead and define the architecture of our backend systems, ensuring they scale with the needs of the business. Architect and guide the build of marketing technologies, predictive systems, and intelligent decisioning engines supporting the home-services consumer journey. Own and evolve core backend systems, including: Lead Management Platform (intelligent routing, partner integrations, auctions) Ad Targeting & Conversion Upload Systems (real-time pipelines optimizing platform feedback loops) Oversee infrastructure, codebases, and data flows across lead management, conversion upload systems, and backend integrations. Drive technical strategy and roadmap creation across backend engineering and integrations. Collaborate with data engineering and front-end teams. Partner with business, product, and data leaders to ensure systems meet performance, reliability, and scalability goals. Serve as a strategic thought partner to evaluate new technologies, architecture patterns, and long-term platform investments. Hands-On Principal Engineering Leadership: Demonstrate deep technical expertise by designing and building high-scale, high-reliability systems. Implement scalable services using modern languages and frameworks (e.g., Elixir Phoenix, Python, JavaScript/TypeScript). Build cloud-native systems leveraging modern DevOps and AWS practices: IaC, CI/CD, identity management, observability, cost-optimized service design. Integrate predictive models, decisioning frameworks, and real-time data pipelines into mission-critical workflows. Apply an AI-superuser mindset - using AI-driven tooling, automation, and workflows to accelerate engineering output and quality. Take ownership of complex problems and deliver high-impact solutions with speed, clarity, and craftsmanship. Mentor, Develop, and Champion Excellence: Shape a culture of engineering excellence while growing and guiding a high-performing team. Mentor a team of software and data engineers, supporting their technical growth and delivery. Establish and uphold best practices for testing, code quality, automation, security, and system reliability. Provide architectural guidance, conduct deep technical reviews, and support engineers in making strong, scalable design decisions. Foster a mindset of high ownership, continuous improvement, and operational excellence across the engineering team. Create clarity in technical decision-making and help maintain a fast-paced, accountable environment. About You You are a senior technical leader with a continuous improvement mindset and a passion for architecting and building modern, scalable systems. 8+ years of engineering experience with increasing architectural and technical leadership responsibility. Significant experience designing and owning enterprise tech stacks for high-growth or complex digital businesses. Deep expertise in backend engineering, distributed systems, and modern API protocols. Experience with cloud infrastructure design in AWS. Programming expertise in languages such as Elixir, Python, JavaScript/TypeScript. Strong communicator able to partner effectively with Product, Data Science, and business stakeholders. Comfortable owning ambiguous, high-impact problems and driving them to completion. Proactive risk mitigation mindset with high urgency when critical issues arise. Motivated by autonomy, craftsmanship, and leveraging automation or AI to deliver better, faster outcomes. Nice to have: Data Architecture and Engineering Experience. Experience building or integrating modern data warehouses and pipelines (Postgres, Airflow, Fivetran). Strong SQL skills and experience with PostgreSQL and high-volume transactional systems. About Us Launched Fall 2017, Home Solutions targets the rapidly digitizing home services vertical and matches homeowners with the right service provider to meet their needs. Through our websites, Home Solutions has a proprietary audience of 47M+ homeowners and prime real estate in search engines. We are on a mission to make homeownership easier by creating high quality content that pairs consumers with providers in a range of related categories. Home Solutions was incubated within Three Ships, a growth equity firm that launches and invests in digital companies, builds great leadership teams, and helps them rapidly scale. The Three Ships portfolio currently includes several businesses - Home Solutions, Pillar 4, and Guardian Service. Why You Should Join Us Results: Home Solutions is the fastest-growing marketplace company in the home services category. Opportunity: Home services is a $600 billion market that largely still operates like it's 1999. During the next decade, we anticipate a huge digital transformation in the category, and marketplace companies will lead the way. Ownership & Impact: We seek talented people with the desire to own and run parts of the business that drive company performance. Leadership is fully aligned and incentivized around our growth-focused mission. Exposure & Learning: You will have a front-row seat in growing a business. Your teammates have built and sold companies, managed 100s of employees, and run campaigns with Fortune 500 brands. The opportunity to build new skills and learn from smart people is endless. Career Growth: There is no cap on growth, promotions, or the opportunity to own and put your stamp on important projects. Prove your value and you will be rewarded accordingly. Fun: The team has a high bar for excellence, but also a real interest in each other and making work fun The Package As a full-time employee of Home Solutions, you'll have access to competitive benefits, including flexible time off, health/dental/vision, 401k match, an annual Relax & Recharge Bonus, an annual Learning & Development stipend to enroll in class(es) of your choosing, and up to $75 mobile reimbursement. If you join us in person in our Raleigh or Charlotte locations, we have an office stocked with snacks, coffee, and just about every other beverage you can imagine. EEOC Statement All applicants are considered without regard to race, color, religion, sex, national origin, age, disability, veteran status, gender identity, or any other discriminatory factors. Please note that we do not provide immigration sponsorship for this role. All offers are subject to a background check.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Builds relationship and demonstrates the clinical outcome and benefits of company products to thought leaders, medical groups, government agencies, key opinion leaders and health systems with drug formularies, consumer-ready medical and dental products. Educates and demonstrates the benefits of key products to clinical professors, teaching-hospital faculty, residents, and students. Provides medical information to internal/external health sources such as the sales force, outside health professions, public, and government. Explores and identifies sites for clinical trial in all stages of development. Coordinates continuing education workshops, seminars, and programs for graduate physicians, pharmacists, and scientists. Responds to unsolicited inquiries to establish and/or further the knowledge and understanding of marketed products and related topics. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS:\ Product/Therapeutic Area Support to Stakeholders · Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding. · Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups. · Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests. · Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested. · Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities. · Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource · Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data · Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives · Serve as technical/scientific subject matter resource to Eisai cross functional partners · Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning. · Ability to lead and motivate team members without a direct reporting relationship Research Support · Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials. · The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: · 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title · Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred · 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting. · Strong broad-based scientific and pharmaceutical knowledge · Clinical trial development and drug launch experience is strongly preferred · Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required. · Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: · Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs. · Committed to the concept of team and working within the framework of the Medical Affairs · Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately. · Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately. · Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs. · Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies. · Interest in leading and participating in projects while effectively balancing field work. · Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them. · Seamlessly adapts to field situations and effectively problem solves within your territory · Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies · Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing · Possesses and maintains a valid driver's license and clean driving record. · Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends. · This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Sr. MSL, Neurology - Alzheimer's Disease, Southern Ohio- Field based is from :$160,100-$210,100Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

This person will be responsible for the day-to-day administration of the Microsoft 365 Purview and Entra ID platforms, as well as the Veritas Data Insight platform, in a heavily-regulated GxP environment. This person will be responsible for working with business and technical leaders to identify systems containing critical data and labeling them accordingly. S/he will be responsible for creating data protection awareness programs for end-users and using standardized metrics to document compliance. S/he will participate in incident investigations and assist, when necessary, to resolve complex software and hardware problems. This person will be required to follow strict change control processes and perform other tasks as assigned by management. Key Duties and Responsibilities: Must have expert-level experience with managing and configuring Microsoft Purview and Entra ID as it relates to Conditional Access policies, Sensitivity Labels, data classification, data sensitivity labels, e-Discovery, management of the Entra ID synchronization process, and creation of rules and alerts within Microsoft CASB. Ability to use Microsoft Purview to produce operational metrics on a regular basis for management review. Proven experience supporting and deploying functionality provided through the Microsoft Defender Portal and the Microsoft 365 Security & Compliance Center, including Audit, Activity Explorer, and other data protection controls. Support initiatives performed by the Vertex Microsoft 365 team to ensure compliance and operational effectiveness from an Information Security and data protection perspective. Create training materials to expand the adoption of identifying and labeling data using Microsoft 365 Sensitivity Labels. Must have expert-level experience with Veritas Data Insight. Ability to independently create data usage reports (including DQL reports), integrate new sources of Vertex data, create and deploy policies, generate sensitive information tags, create usage metrics for senior leadership, and other tasks related to identifying/tagging data through the Data Insight platform Experience with SailPoint ISC and Data Access Security is a plus. Any other tasks assigned by the Vertex management team. Knowledge and Skills: Must have 3-5 years of experience with Microsoft 365 Purview and the Microsoft 365 Compliance suite. Must have 3-5 years of experience using Veritas Data Insight, especially policy creation, report creation and DQL. Must have experience with data classification policies and proven abilities to identify data and assign policies accordingly. Experience supporting Microsoft CoPilot as it relates to data discovery. Experience supporting SailPoint is a plus. Ability to work well with peers and all levels of management. Must be able to work independently and produce positive results. Pays strict attention to detail. Very strong organizational, task management and prioritization skills. Desire to learn new technologies. Understands the importance of accuracy and responsiveness. 3-5 years working in an Information Security organization. Excellent written skills. Previous experience in an FDA regulated environment is a plus. Education and Experience: Bachelor's degree or equivalent experience Typically requires 6 years of experience or the equivalent combination of education and experience #LI-HYBRID Pay Range: $147,600 - $221,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

We are Generac, a leading energy technology company committed to powering a smarter world. Over the 60 plus years of Generac's history, we've been dedicated to energy innovation. From creating the home standby generator market category, to our current evolution into an energy technology solutions company, we continue to push new boundaries. We are seeking a Principal Product Compliance Engineer to provide both technical leadership and team guidance in ensuring our energy storage systems and related technologies meet global safety, certification standards. This role blends hands-on design-for-compliance expertise with mentorship of compliance engineers, while also representing the company in key standards committees to anticipate and influence regulatory changes. You will drive compliance strategy from concept through certification, ensuring safe, reliable, and innovative products that align with evolving industry requirements. Key Responsibilities: Act as design-for-compliance lead, ensuring safety and compliance requirements are integrated into products from concept through production. Partner with R&D, electrical, and mechanical engineering teams to embed UL, IEC, NFPA, and IEEE requirements into architecture, schematics, BOMs, and design reviews. Define and maintain compliance design guidelines and checklists for battery packs, modules, and complete ESS. Provide expertise on fire mitigation strategies, protective circuits, insulation systems, and safety-critical components. Standards & Regulatory Engagement Represent the company in standards committees and regulatory working groups (UL, IEEE, NFPA, IEC, NEC, NERC CIP, etc.). Anticipate and influence regulatory changes to ensure standards support innovation while maintaining safety. Prepare technical white papers and provide input to regulatory initiatives. Communicate upcoming changes, impacts, and risk mitigation strategies internally across engineering and product teams. Qualifications: Minimum BSEE. MS or PhD preferred. 12+ years of experience in product compliance and certification Deep knowledge of ESS standards, including: ESS & Hybrid Systems: UL 9540, UL 1973, UL 9540A/B, UL 1741, UL 2941, UL 6200, NFPA 855, NEC, IEEE 1547 International & Transport: IEC 62619, IEC 62933, UN 38.3 Prior experience mentoring engineers strongly preferred. Deep knowledge of UL, IEC, NFPA, IEEE, and NEC standards for energy storage and generation systems. Demonstrated experience engaging with standards committees and certification bodies. Strong communication skills, with ability to translate regulatory requirements into practical design guidance. Proven ability to manage multiple priorities, projects, and deadlines in a fast-paced environment. Excellent organizational, communication, and stakeholder management skills Demonstrated ability to connect regulatory requirements with system-level design decisions Physical Demands: While performing the duties of this job, the employee is regularly required to talk and hear; and use hands to manipulate objects or controls. The employee is regularly required to stand and walk. On occasion the incumbent may be required to stoop, bend or reach above the shoulders. The employee must occasionally lift up to 25 - 50 pounds. Specific conditions of this job are typical of frequent and continuous computer-based work requiring periods of sitting, close vision and ability to adjust focus. Occasional travel. “We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.”

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com Provides expertise in the optimization of product development. How you will make an impact: Design and develop components and systems utilizing SolidWorks design tools while applying mechanical engineering principals. Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work. Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystems Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements Develop project plans to assess technology and drive project results Train, coach, and guide lower-level employees on more complex procedures What you'll need (Required): Bachelor's Degree in Mechanical Engineering with a minimum of 8 years' experience including either industry or industry/education or Master's Degree or equivalent in in Engineering or Scientific field with a minimum of 6 years' experience, including either industry or industry/education Required or What else we look for (Preferred): Experience with Ansys and or Icepak FEA tools Excellent documentation and communication skills Excellent interpersonal relationship skills including negotiating and relationship management skills Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering Advanced problem-solving, organizational, analytical and critical thinking skills Extensive understanding of processes and equipment used in assigned work Ability to influence others Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts Represents organization in providing solutions to difficult technical issues associated with specific projects Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Irvine Laguna CanyonAdditional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $124,700.00 - $205,800.00 USD Annual

Conducts performance and reliability testing for hardware and devices, ensures adherence to quality standards and specifications, identifies issues, sets testing parameters, and documents and improves test processes.Responsibilities The Professional performs some or all of the following accountabilities as assigned: Testing standard and/or custom products, devices, and/or hardware to assess their performance and reliability Ensuring products/devices are designed and implemented in accordance to established quality standards and specifications Serving as a primary source for problem identification and improvement Selecting testing specifications for new/existing products/devices and ensuring testing procedures are in compliance to industry standards Documenting procedures for all phases of testing and test results Improving and automating the test methodology All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. REQUIREMENTS Bachelor's degree in Engineering (Mechanical, Computer, Biomedical or related) or equivalent experience ·Knowledge of electro-mechanical medical device and software testing Strong organizational skills Exceptional analytical and technical writing skills Knowledge of quality systems and medical device standards Ability to work in a laboratory environment Self-motivated, curious, and detail-oriented team member with proven critical thinking skills Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

For a Biotech Company We are looking for an Instruments Engineer: The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms. LOCATION On -site 3 -4 days/week between Marlborough, MA JOB RESPONSIBILITIES Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives Identify opportunities to optimize current processes and implement upgraded solutions Ensure GMP compliance in the design, delivery, and maintenance of all systems Maintain inspection readiness throughout the duration of the project Participate in internal and external audits as required Requirements Bachelor's degree or equivalent in science, engineering, or computer science discipline 5 to 7+ years' experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a bio pharmaceutical GMP environment Direct experience with automation solutions such as Hamilton Venus Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers Experience with GAMP and GxP compliance regulation Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization Experience with Digital systems hosted in the cloud and an understanding of connectivity between on -prem systems and SAAS/Cloud Strong understanding of core laboratory systems, related processes, and quality management workflows Ability to work independently and in a team setting, with the ability to effectively communicate cross -functionally Ability to support multiple concurrent projects in a fast -paced environment Strong interpersonal and relationship -building skills BenefitsAttractive Base Salary plus Benefits No Sponsorship Available for this Role.

Principal Engineering Investigator exists to ensure the accuracy, integrity, and timeliness of all technical investigations and CAPAs associated with sterile compounding and injectable manufacturing operations. This role is accountable for collaborating with the team that identifies true root causes, develops effective and implements sustainable corrective/preventive actions, and communicates results that withstand regulatory scrutiny. The role is pivotal in supporting continuous improvement initiatives that enhance and transform the quality, compliance, and operational efficiency while fostering a strong culture of accountability and excellence across Quva. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Principal Engineering Investigator Does Each Day: Lead end-to-end analytical and manufacturing-related investigations, including out-of-specification (OOS), out-of-trend (OOT), analytical deviations, data anomalies, and lab incidents Ensure investigations are scientifically sound, compliant, and completed within defined timelines, meeting all cGMP and regulatory expectations (FDA, EMA, USP /, and 503B guidance) Apply structured problem-solving tools (e.g., 5 Whys, Fishbone Diagram, Fault Tree, FMEA, KT Analysis) to determine true root causes and recommend durable corrective and preventive actions Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams to collect data, review trends, and verify CAPA effectiveness Review, approval, and/or author high-complexity investigation reports, technical assessments, and CAPA documentation to ensure technical accuracy and regulatory compliance Identify and trend recurring issues, conducting periodic reviews to drive continuous improvement initiatives that enhance product quality and operational consistency Perform thorough data review, analytical method assessments, equipment troubleshooting, and sample/laboratory workflow evaluation Lead investigation, readiness, efforts and support internal and external audits, providing detailed summaries of investigation history, CAPA status, and site performance metrics Collaborate with stakeholders to implement CAPAs, track progress, and verify effectiveness Promote a culture of accountability and right-first-time documentation Train others on Root Cause methodologies Implement CAPA's with a mindset of driving the process with a Poke Yoke solution The end state of the role is to reduce errors to the point where they can shift to more continuous improvement opportunities and release capacity and capture business opportunities as a result of their efforts Prepare clear, concise, and defensible investigation reports that meet internal quality standards and FDA/EMA regulatory expectations Support internal, customer, and regulatory inspections by presenting investigation logic, risk reasoning, and CAPA justification Our Most Successful Principal Engineering Investigator: Has deep understanding of aseptic manufacturing processes and regulatory standards Ability to mentor, coach, and develop high-performing technical staff Applies sound judgment in resolving complex technical and quality issues Has strong data analysis and trend evaluation capabilities. Ability to set data sets up to measure process capability, control charts for ongoing monitoring/effectiveness Builds effective partnerships across cross-functional teams. Ability to work with the shop floor to engage in problem solving and also have executive presence to present to leadership Champions a culture of compliance, integrity, and continuous improvement Delivers clear, concise, and scientifically sound documentation and presentations Minimum Requirements for this Role: Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or related discipline required Minimum 5-7 years of experience in pharmaceutical or sterile injectable manufacturing Demonstrated success managing investigations, CAPA programs, and technical documentation in a cGMP-regulated environment KT Analysis certified Strong working knowledge of sterile compounding, aseptic processing, cleanroom operations, and environmental control systems Deep understanding of FDA and EMA inspection expectations, particularly regarding data integrity, documentation practices, and deviation management Expertise in root cause analysis and problem-solving methodologies Proficiency with electronic Quality Management Systems (eQMS) such as MasterControl, TrackWise, or Veeva Strong technical writing and documentation review skills Proficiency in Microsoft Office Suite and analytical tools (specifically Visio, Excel, Mini-Tab or JMP; Mind Manager or other brainstorming software preferred) Ability to lead/facilitate Kaizan in problem solving Any of the Following Will Give You an Edge: Lean or Six Sigma qualified. Experience with Lean Transformation is a plus, specifically McKinsey transformation Experience supporting 503B outsourcing facilities, sterile injectables, or hospital compounding preferred Benefits of Working at Quva: Set, full-time, consistent work schedule Comprehensive health and wellness benefits including medical, dental and vision 401k retirement program with company match 17 paid days off plus 8 paid holidays per year National, industry-leading high growth company with future career advancement opportunities The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions Range: $88,792 - $116,838 Annually About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.” California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

Purpose: The Principal Metrology Engineer provides measurement services to support product development, benchmarking, production, and manufacturing process development for JTEKT North America. The role is primarily focused on current products and their mating components. Essential Duties and Accountabilities: Metrology fundamentals activities: Leads metrological work covering a variety of products and mating components. Performs or guides collection of measurements per established methods when available. Defines gaging methods when not previously established Properly interprets and applies GD&T to measurements; may be called upon to advise designers on use and application of GD&T to product prints. Suggests improvements to methods as appropriate. Resonsible for metrology equipment (with Metrology Consultant): Operation, calibration, and maintenance. Equipment includes TSK and Taylor Hobson. CMM is Sheffield, and there is a variety of other more specific instruments. Works with Metrology Consultant to identify trends and technology improvements; assists in the development of mid- and long-term metrology plan; participates in developing recommendations for purchase of new technology/machines as appropriate; assists with training technical staff to maintain/improve lab capability. Support of Production, Product Validation, and New Business Launches: Works alongside with Metrology Lab Manager, Metrology Consultant, and with Application and Product Engineering management to identify gaps in capability to support new product/business launches; directly supports and/or leads project teams (as appropriate) to develop new gages or gaging methods; trains staff in current and new techniques as needed/appropriate. Works with lab managers to secure technician support as needed. Perform other duties as assigned Supervisory Responsibilities This position has no direct supervisory responsibilities, though providing specific task direction to technicians is expected. May be called upon to participate or lead a Cross-Functional Project Team if required. Requirements: BS in Engineering (STEM) or equivalent; advanced degree preferred 10 - 15 years' experience Demonstrated expertise with metrology equipment, and data acquisition systems. Ability to troubleshoot problems with hardware and software Demonstrated expertise in programming of metrology equipment Recognized expertise with the application and interpretation of GD&T; gaging development Demonstrated skill with mechanical and electrical systems Experience with quality management systems, specifically TS16949 (ISO9001) Other Desirable Experience: Knowledge of bearing design, applications, manufacturing, and/or damage analysis Strong written and verbal communication skills Team skills TSK Calypso programming knowledge is a plus Work Environment/Physical Demands: Primarily office/Metrology Lab, but may occasionally require exposure to manufacturing areas which require the use of personal protective equipment such as safety glasses with side shields and mandatory hearing protection. Working with components up to 50 lbs PPE (when required): safety glasses, steel toe shoes, ear plugs, and requirements to follow all safety guidelines Majority of work required to be on site in Greenville Test Lab.

Vertex is a global biotechnology company that invests in scientific innovation. The Data, Technology and Engineering (DTE) Research, Pre-Clinical, Manufacturing & Supply (RPMS) Group's mission is to improve the lives of patients through digital, data, and technology innovation. Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission and enable Vertex to grow in scale; ensuring we remain on the forefront of science, medicine and technology. Role Overview We are seeking a data driven, scientifically literate, and technically skilled Principal Engineer to serve as the Automated Data QC and Reporting Solutions lead to automate and streamline pre-clinical data pipelines and reporting processes and ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories.We are seeking a data driven, scientifically literate, and technically skilled Principal Engineer to serve as the Automated Data QC and Reporting Solutions lead to automate and streamline pre-clinical data pipelines and reporting processes and ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories. This role will drive the modernization and standardization of data pipelines and reporting processes, ensuring accuracy, consistency, and integrity of high-impact, business-critical regulatory documents across research laboratories. The Principal Engineer will also develop and execute strategies for data consumption solutions and reporting, leveraging advanced technology, agentic workflows, and AI capabilities to modernize and scale data consumption environments. Key Duties and Responsibilities Develop and execute modernization and standardization initiatives for automated QC and reporting of research data, ensuring alignment with business objectives and digital transformation goals. Lead the development of data consumption solution strategies and reporting frameworks to enable scalable, future-ready, and unified data environments. Identify and implement innovative digital and AI-powered technologies, including agentic workflows, to enhance data consumption, reporting, and scientific insight generation. Collaborate with cross-functional teams to align global digital QC, reporting, and data consumption strategies across multiple research sites. Operational Execution Design, configure, develop, and maintain automated solutions, tools, and workflows for QC, report generation, and standardized data consumption. Regularly evaluate and optimize solutions, scripts, and workflows to enhance performance, scalability, and interoperability. Identify and prepare raw data files in response to regulatory requests. Deliver solutions to automate and digitalize by identifying and preparing raw data files in response to regulatory requests. Design, configure, develop and maintain automated solutions, tools and workflows for automated QC and report generation. Ensure the accuracy, completeness, traceability and consistency of data across research business-critical documents (e.g. research study reports). Ensure generated reports meet formatting, regulatory, data integrity, and quality standards. Identify and resolve data discrepancies using automated processes, collaborating with stakeholders. Collaborate across our Data Technology & Engineering (DTE) organization and with research scientists to ensure solutions integrate with our broader data platform and data engineering strategy. Ensure the accuracy, security, quality and business continuity of solutions in line with Vertex and external data and technology standards. Modernization and AI Enablement Drive the adoption of agentic workflows and AI capabilities to automate and accelerate scientific data workflows, reporting, and consumption interfaces Develop and deploy AI-enhanced visualization, reporting, and QC interpretation tools. Champion the use of cloud-native and unified semantic consumption layers for scalable data access and analysis. Collaboration and Communication Partner with scientists, statisticians, and program representatives to understand reporting and QC requirements. Partner with DTE leaders to understand and deliver to data and technical requirements. Provide leadership and training to a team of super users on automated QC and report generation workflows to ensure business continuity. Develop a sustainable suite of solutions that minimize future training. Deliver solutions and insights with clear and actionable QC and reporting summaries to stakeholders. Required Knowledge and Skills Experience designing and implementing data and technology solutions in life sciences research and development. Advanced programming skills in R, Python, and experience with database access, query, and large dataset interrogation. Expertise in agentic workflows, AI/ML technologies, and cloud-native platforms for data engineering and reporting. Proficiency in evaluating and implementing new tools and technologies, including AI and agentic workflows. Proficiency in data management and automation principles and methodologies. Knowledge of statistics, data visualization, and scientific reporting. Familiarity with data quality, reporting, and compliance requirements in regulated environments. Excellent collaboration, interpersonal, and communication skills, with the ability to present complex technical concepts to diverse audiences. Strong analytical, problem-solving, and decision-making skills using data-driven approaches. Strong collaboration and inter-personal skills. Proven track record of working in a complex, fast-paced environment. Willingness to travel as needed (up to 10%) to support business objectives. Required Education and Experience Bachelor's degree in a relevant field such as Computer Science, Data Science, Engineering, or a related discipline or equivalent experience; advanced degree preferred. 5+ years of experience in technical leadership, data management, or related roles within the biotechnology or pharmaceutical industry. Proven track record of leveraging data engineering, software engineering and or data science skills to automate reporting. Proficiency in digital platforms and technologies, with the ability to evaluate and implement new tools and technologies. Proven track record in leading digital transformation, modernization, and standardization initiatives. #LI - Hybrid Pay Range: $148,000 - $222,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Vertex is a global biotechnology company that invests in scientific innovation. The Data, Technology and Engineering (DTE) Research, Pre-Clinical, Manufacturing & Supply (RPMS) Group's mission is to improve the lives of patients through digital, data, and technology innovation. Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission and enable Vertex to grow in scale; ensuring we remain on the forefront of science, medicine and technology. Role Overview We are seeking a data driven, scientifically literate, and technically skilled Principal Engineer to serve as the Automated Data QC and Reporting Solutions lead to automate and streamline pre-clinical data pipelines and reporting processes and ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories.We are seeking a data driven, scientifically literate, and technically skilled Principal Engineer to serve as the Automated Data QC and Reporting Solutions lead to automate and streamline pre-clinical data pipelines and reporting processes and ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories. This role will drive the modernization and standardization of data pipelines and reporting processes, ensuring accuracy, consistency, and integrity of high-impact, business-critical regulatory documents across research laboratories. The Principal Engineer will also develop and execute strategies for data consumption solutions and reporting, leveraging advanced technology, agentic workflows, and AI capabilities to modernize and scale data consumption environments. Key Duties and Responsibilities * Develop and execute modernization and standardization initiatives for automated QC and reporting of research data, ensuring alignment with business objectives and digital transformation goals. * Lead the development of data consumption solution strategies and reporting frameworks to enable scalable, future-ready, and unified data environments. * Identify and implement innovative digital and AI-powered technologies, including agentic workflows, to enhance data consumption, reporting, and scientific insight generation. * Collaborate with cross-functional teams to align global digital QC, reporting, and data consumption strategies across multiple research sites. Operational Execution * Design, configure, develop, and maintain automated solutions, tools, and workflows for QC, report generation, and standardized data consumption. * Regularly evaluate and optimize solutions, scripts, and workflows to enhance performance, scalability, and interoperability. * Identify and prepare raw data files in response to regulatory requests. * Deliver solutions to automate and digitalize by identifying and preparing raw data files in response to regulatory requests. * Design, configure, develop and maintain automated solutions, tools and workflows for automated QC and report generation. * Ensure the accuracy, completeness, traceability and consistency of data across research business-critical documents (e.g. research study reports). * Ensure generated reports meet formatting, regulatory, data integrity, and quality standards. * Identify and resolve data discrepancies using automated processes, collaborating with stakeholders. * Collaborate across our Data Technology & Engineering (DTE) organization and with research scientists to ensure solutions integrate with our broader data platform and data engineering strategy. * Ensure the accuracy, security, quality and business continuity of solutions in line with Vertex and external data and technology standards. Modernization and AI Enablement * Drive the adoption of agentic workflows and AI capabilities to automate and accelerate scientific data workflows, reporting, and consumption interfaces * Develop and deploy AI-enhanced visualization, reporting, and QC interpretation tools. * Champion the use of cloud-native and unified semantic consumption layers for scalable data access and analysis. Collaboration and Communication * Partner with scientists, statisticians, and program representatives to understand reporting and QC requirements. * Partner with DTE leaders to understand and deliver to data and technical requirements. * Provide leadership and training to a team of super users on automated QC and report generation workflows to ensure business continuity. * Develop a sustainable suite of solutions that minimize future training. * Deliver solutions and insights with clear and actionable QC and reporting summaries to stakeholders. Required Knowledge and Skills * Experience designing and implementing data and technology solutions in life sciences research and development. * Advanced programming skills in R, Python, and experience with database access, query, and large dataset interrogation. * Expertise in agentic workflows, AI/ML technologies, and cloud-native platforms for data engineering and reporting. * Proficiency in evaluating and implementing new tools and technologies, including AI and agentic workflows. * Proficiency in data management and automation principles and methodologies. * Knowledge of statistics, data visualization, and scientific reporting. * Familiarity with data quality, reporting, and compliance requirements in regulated environments. * Excellent collaboration, interpersonal, and communication skills, with the ability to present complex technical concepts to diverse audiences. * Strong analytical, problem-solving, and decision-making skills using data-driven approaches. * Strong collaboration and inter-personal skills. * Proven track record of working in a complex, fast-paced environment. * Willingness to travel as needed (up to 10%) to support business objectives. Required Education and Experience * Bachelor's degree in a relevant field such as Computer Science, Data Science, Engineering, or a related discipline or equivalent experience; advanced degree preferred. * 5+ years of experience in technical leadership, data management, or related roles within the biotechnology or pharmaceutical industry. * Proven track record of leveraging data engineering, software engineering and or data science skills to automate reporting. * Proficiency in digital platforms and technologies, with the ability to evaluate and implement new tools and technologies. * Proven track record in leading digital transformation, modernization, and standardization initiatives. #LI - Hybrid Pay Range: $148,000 - $222,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Vertex is a global biotechnology company that invests in scientific innovation. The Data, Technology and Engineering (DTE) Research, Pre-Clinical, Manufacturing & Supply (RPMS) Group's mission is to improve the lives of patients through digital, data, and technology innovation. Vertex is in a transformational period where we are accelerating our capabilities, technology and data to augment our scientific mission and enable Vertex to grow in scale; ensuring we remain on the forefront of science, medicine and technology. Role Overview We are seeking a data driven, scientifically literate, and technically skilled Principal Engineer to serve as the Automated Data QC and Reporting Solutions lead to automate and streamline pre-clinical data pipelines and reporting processes and ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories.We are seeking a data driven, scientifically literate, and technically skilled Principal Engineer to serve as the Automated Data QC and Reporting Solutions lead to automate and streamline pre-clinical data pipelines and reporting processes and ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories. This role will drive the modernization and standardization of data pipelines and reporting processes, ensuring accuracy, consistency, and integrity of high-impact, business-critical regulatory documents across research laboratories. The Principal Engineer will also develop and execute strategies for data consumption solutions and reporting, leveraging advanced technology, agentic workflows, and AI capabilities to modernize and scale data consumption environments. Key Duties and Responsibilities * Develop and execute modernization and standardization initiatives for automated QC and reporting of research data, ensuring alignment with business objectives and digital transformation goals. * Lead the development of data consumption solution strategies and reporting frameworks to enable scalable, future-ready, and unified data environments. * Identify and implement innovative digital and AI-powered technologies, including agentic workflows, to enhance data consumption, reporting, and scientific insight generation. * Collaborate with cross-functional teams to align global digital QC, reporting, and data consumption strategies across multiple research sites. Operational Execution * Design, configure, develop, and maintain automated solutions, tools, and workflows for QC, report generation, and standardized data consumption. * Regularly evaluate and optimize solutions, scripts, and workflows to enhance performance, scalability, and interoperability. * Identify and prepare raw data files in response to regulatory requests. * Deliver solutions to automate and digitalize by identifying and preparing raw data files in response to regulatory requests. * Design, configure, develop and maintain automated solutions, tools and workflows for automated QC and report generation. * Ensure the accuracy, completeness, traceability and consistency of data across research business-critical documents (e.g. research study reports). * Ensure generated reports meet formatting, regulatory, data integrity, and quality standards. * Identify and resolve data discrepancies using automated processes, collaborating with stakeholders. * Collaborate across our Data Technology & Engineering (DTE) organization and with research scientists to ensure solutions integrate with our broader data platform and data engineering strategy. * Ensure the accuracy, security, quality and business continuity of solutions in line with Vertex and external data and technology standards. Modernization and AI Enablement * Drive the adoption of agentic workflows and AI capabilities to automate and accelerate scientific data workflows, reporting, and consumption interfaces * Develop and deploy AI-enhanced visualization, reporting, and QC interpretation tools. * Champion the use of cloud-native and unified semantic consumption layers for scalable data access and analysis. Collaboration and Communication * Partner with scientists, statisticians, and program representatives to understand reporting and QC requirements. * Partner with DTE leaders to understand and deliver to data and technical requirements. * Provide leadership and training to a team of super users on automated QC and report generation workflows to ensure business continuity. * Develop a sustainable suite of solutions that minimize future training. * Deliver solutions and insights with clear and actionable QC and reporting summaries to stakeholders. Required Knowledge and Skills * Experience designing and implementing data and technology solutions in life sciences research and development. * Advanced programming skills in R, Python, and experience with database access, query, and large dataset interrogation. * Expertise in agentic workflows, AI/ML technologies, and cloud-native platforms for data engineering and reporting. * Proficiency in evaluating and implementing new tools and technologies, including AI and agentic workflows. * Proficiency in data management and automation principles and methodologies. * Knowledge of statistics, data visualization, and scientific reporting. * Familiarity with data quality, reporting, and compliance requirements in regulated environments. * Excellent collaboration, interpersonal, and communication skills, with the ability to present complex technical concepts to diverse audiences. * Strong analytical, problem-solving, and decision-making skills using data-driven approaches. * Strong collaboration and inter-personal skills. * Proven track record of working in a complex, fast-paced environment. * Willingness to travel as needed (up to 10%) to support business objectives. Required Education and Experience * Bachelor's degree in a relevant field such as Computer Science, Data Science, Engineering, or a related discipline or equivalent experience; advanced degree preferred. * 5+ years of experience in technical leadership, data management, or related roles within the biotechnology or pharmaceutical industry. * Proven track record of leveraging data engineering, software engineering and or data science skills to automate reporting. * Proficiency in digital platforms and technologies, with the ability to evaluate and implement new tools and technologies. * Proven track record in leading digital transformation, modernization, and standardization initiatives. #LI - Hybrid Pay Range: $148,000 - $222,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Why Should You Join Our Success Story? Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient's own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S. What We're Looking For: The Senior Embedded Engineer contributes significantly to the development of Myomo's advanced wearable robotics platform, focusing primarily on embedded firmware for microcontrollers and software in the Linux environment. This role combines technical depth, architectural insight, and cross-functional collaboration to deliver safe, secure, and high-quality software in alignment with business and regulatory goals. The Senior Embedded Engineer collaborates with the cross-functional team and consultants to lead the design and implementation of the core software for the MyoPro. The role includes helping others on the team grow with opportunities to establish technical standards, mentor engineers, and contribute to knowledge sharing. How You'll Drive Impact: Software Development * Define and maintain software architectures in collaboration with Engineering, IT, and Product Management, prioritizing safety, cybersecurity, reliability, scalability, and maintainability. * Design, implement, test and document robust embedded firmware and Linux-based software solutions. * Review code and technical designs with a focus on quality and long-term maintainability. Leadership * Collaborate closely with Engineering, Product, Quality, and Clinical teams to translate user needs into robust deliverable solutions. * Improve software quality through test-driven development, code standards, and continuous integration practices. * Foster knowledge-sharing and technical growth through mentorship. What You'll Bring: * Bachelor's degree in Computer Science, Engineering or related field. * 8-10+ years' professional experience in embedded/software engineering. * Demonstrated expertise in Embedded firmware for electromechanical devices. * Extensive experience with software delivery in regulated environments. (E.g. medical, automotive, aerospace) * Strong proficiency in at least one embedded-level programming language (E.g., C/C++), and one application-layer language. (E.g., Python, Dart, JavaScript/TypeScript) * Proficiency with Linux, FreeRTOS, and real-time or resource-constrained environments. * Experience with communication libraries and interface design for BLE, UART, I2C, SPI, and CAN. * Familiarity in Agile methodologies and modern DevOps tools. (E.g., Git, CI/CD pipelines, Docker, automated testing frameworks) * Strong communication and interpersonal skills; ability to work collaboratively across disciplines. Preferred: * Experience in software development for Class II medical devices. * Experience with cybersecurity requirements related to HIPAA, GDPR, and ISO 27001. * Experience configuring CI/CD and automated testing frameworks. * Ability to debug PCBs using logic analyzers and oscilloscopes. * Background in wearable devices, robotics, or human-centered systems. * Familiarity with process standards including IEC 62304, ISO 13485, ISO 14971. * Familiarity with STM32 ecosystem, ESP32 ecosystem, Torizon Linux. * Familiarity with mobile app development and cloud service integration such as Flutter and AWS.

Senior Power Electronics Engineer Who we are… We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living. Who you are… You love details and precision. You find enjoyment in solving puzzles, designing and mapping systems, and building efficient circuitry. Words that describe you are focused, curious, and collaborative. What you can expect to work on… The Power Electronics Engineer role at Niowave has responsibility over design, implementation and integration of accelerator power systems. These systems are varied and include critical accelerator subsystems like the cathode heater, the electron gun tuners, etc. This position will also involve support to cryogenics, RF, and high voltage subsystems and some involvement in circuits that enable or control specialized accelerator systems like RF and beam loss detectors. Design, implement and maintain accelerator power systems including controlled heaters and tuners. Consult with controls engineers on the proper power layout for normal-conducting beamline magnets and beamline diagnostics. Interface with nuclear engineers concerning the design and operation of the x-ray conversion target. Be part of the team designing the concept, architecture, and components of future systems. Conduct optimization work on existing systems, perform measurements and validation tests Confirm system capabilities by designing testing methods What you need to succeed… Bachelor's degree in the fields of electrical engineering, specifically power electronics and circuits 5+ years of power electronics experience. Experience designing, building and testing systems. Broad understanding of power electronics/circuitry technology. Regularly engages in mentoring multiple team members in all aspects of RF Engineering. Expert level analytical and problem-solving skills; Organizational and project management skills for self and teams. Embrace and model the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understand how to integrate into a new team/organization - appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understand their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two. Great to have… Master's or Doctorate degree in the fields of electrical engineering, power electronics, circuits, etc. 8+ years of power electronics related experience. 5+ or more years of experience with power electronics and accelerators in a research or production environment. Experience leading teams to complete large projects. 2+ years' experience of direct supervisory experience of five or more people. Work Environment… Full-time position. The company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to meet technical objectives and to meet with staff working outside of the standards operating hours as needed. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. Please provide a cover letter specifically describing the nature of your technical expertise.