Post job

Product Engineer jobs at Takeda Pharmaceuticals U.S.A., Inc.

- 471 jobs
  • Senior CQV Engineer

    IPS-Integrated Project Services 4.3company rating

    Cary, NC jobs

    At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Senior CQV Engineer to join our team at our office located in _____________. In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients. Additional Responsibilities Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms C/Q/V Protocols and Summary Reports Standard Operating Procedures Impact Assessments Specifications (URS/FRS/DDS) FATS/SATs Perform field/site activities including, but not limited to, the following: Attend and witness FATs and SATs as a representative of IPS clients. Execution of commissioning forms and witnessing of vendor start-up and testing. Execution of C/Q/V protocols. Walkdown and verification of system drawings (P&IDs, as-builts, etc.) Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons! Qualifications & Requirements Bachelor of Science in Engineering. This is an entry-level position. 7 or more years of relevant experience. Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software. General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA. Context & Safety This position will have up to 100% travel to the site, or as required by the assigned project. You may be assigned to a client site for an extended period. Overnight travel or staying in the city of the client's location is possible depending on the assignment. Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan. You may visit active construction sites and will be required to take site safety training and adhere to site safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
    $80k-108k yearly est. 5d ago
  • Associate Field Application Engineer

    Hypermarcas S/A 4.2company rating

    Coppell, TX jobs

    Associate Field Application Engineer Are you ready to develop the future of retail? As the world's leader in IoT and data technologies for commerce, our mission is to help retailers and brands use digitalization to become more efficient, more intelligent, and more sustainable-and in doing so, enable more positive commerce. VusionGroup is a fast-growing, fast-paced retail tech company. We believe that by thinking big and working together as one team-agile thinkers, tech makers, and change agents-we can build the largest retail IoT platform in the world. Job Description As an Associate Field Application Engineer on the Application team, you will make a positive impact by being responsible for: Address and resolve challenges in assessing product readiness through comprehensive alpha and beta testing. Perform on-site analysis to diagnose and pinpoint root causes of technical issues. Ensure optimal conditions for testing and finalizing products, including environment setup and tool configuration. Participate in installing alpha and beta tests, ensuring consistent monitoring, troubleshooting, and delivering actionable feedback to R&D teams. Coordinate and facilitate technical installations by coordinating with customers, partners, Operations, and R&D teams. Ensure products are scalable and supportable post-launch, facilitating transitions from testing to full-scale deployment. Conduct on-site visits to troubleshoot beta test issues, ensuring timely resolutions and seamless operation. Provide regular project status updates and key insights to internal and external stakeholders, ensuring clear communication and transparency. Collaborate with support teams to assist with new product deployments, providing training and guidance as necessary. Escalate unresolved issues promptly, following internal protocols and addressing high-priority concerns effectively. Facilitate continuous feedback loops between customers and internal teams, ensuring customer feedback informs product iterations and improvements. Qualifications Qualifications we're looking for. Experience: At least 2+ years of experience as a Field Service Engineer, Application Engineer, Pre-Sales Engineer or Product Manager in the field of IoT devices, electronic consumer products or SaaS products. Skills: Software: basic coding skills, scripting (e.g. Python), SQL knowledge, Log analysis (like Azure Kusto Query, Sumologic, Splunk) preferred. You have experience with Embedded/IoT devices: radio protocols like Wi-Fi/BLE/Zigbee/LoRa is required. Abilities: Excellent verbal and written communication; ability to convey complex information clearly and understandably. Ability to liaise with individuals across a wide variety of operational, functional, and technical disciplines and work within a virtual global team environment preferred. Ability to travel up to 40% is required. Ability to travel internationally is preferred. Education: University of Applied Sciences or Higher Technical College (with experience) for engineering or equivalent experience. Preferred: Bachelor's Degree in Computer, Electronics or Electrical Engineering We innovate. We help communities thrive. VusionGroup has an international presence in 19 countries. In joining us, you'll be part of a globally distributed team of intellectually curious, committed, and collaborative co-workers. The work is fast paced, challenging, and ambitious. Here, you will feel valued for your contributions as we reinvent modern commerce-together. We feel supported. You will too. VusionGroup is a place where people feel safe, happy, and respected. We offer programs and benefits to support you in whatever comes next in your life, including: Generous paid time off (PTO ): 35 days PTO to enable work/life integration and promotes a culture of trust. Health & Wellness : Eligibility for healthcare benefits begin day one, plus retirement savings plans. Financial future : While retirement savings plans vary by country, we help you plan for your future. Family-First Support : Navigate family challenges with our assistance, securing time for both your loved ones and self-care. Hybrid work : Find your balance with two days working from home, three days in the office, plus the freedom to work anywhere for up to two weeks a year. Time off to volunteer and give back to your community. Career Growth: E-learning opportunities and workshops, and global mobility potential Commute benefits : up to $100/month per employee for commuting expenses. Philanthropy : Our company matches employee donations up to $500 per year for causes close to your heart. Additional Information All your information will be kept confidential according to EEO guidelines.
    $85k-117k yearly est. 19h ago
  • Engineer III, Product Development

    Capsugel Holdings Us 4.6company rating

    Bend, OR jobs

    Location: Bend, OR. This is an on-site position. Relocation assistance is available for eligible candidates and their families, if needed. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. This role is based in Bend, OR, where you'll join a dynamic team focused on developing oral solid dosage forms. You'll contribute to innovative product design and collaborate with cross-functional teams. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. The full list of our global benefits can be found at *************************************** Key Responsibilities: Collaborate with clients and internal teams to define strategy and execute research plans. Apply scientific knowledge to solve challenges in drug delivery, formulation, and manufacturing. Design and interpret experiments to guide product development. Use model-based and risk-based approaches for development and scale-up. Mentor peers and contribute technical expertise. Support products through clinical development and manufacturing. Drive continuous improvement and safety initiatives. Key Requirements: Doctoral degree or equivalent experience in Pharmaceutical Sciences or Engineering. Strong skills in formulation development and bioavailability enhancement. Ability to adapt techniques for various chemicals and dosage forms. Excellent communication and teamwork skills. Experience leading teams and managing deliverables. Understanding of pharmaceutical regulations and GMP. Experience with late-stage clinical development is a plus. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $74k-99k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Engineer III

    Cretex 4.0company rating

    Brooklyn Park, MN jobs

    Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Manufacturing Engineer III Position Summary: The Manufacturing Engineer lll is responsible for leading the manufacturing process development of new products and implementation of new manufacturing processes.This position will also be responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes (such machining, packaging, welding, assembly, and molding). Responsibilities Supports new product development team within Cretex Medical - working on projects that are aimed on bringing in new technology and manufacturing solutions to Cretex Medical Responsible for creating manufacturing solutions for new projects either customer driven or internally driven Interface with external and internal stakeholders of the project and take ownership of providing timely project updates, communicating schedule, risks, or delays. Owner of process flow and implementation of all processes required for assigned project/product Support implementation of new technology to Cretex Medical - may include vendor selection, equipment ordering, IQ/SAT, process development, and training. Write Technical reports summarizing builds as well as maintain applicable work instructions. Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology Interface with quality and manufacturing to integrate new products or processes into the existing production area Maintain and approve device routers and bill of materials Maintain and approve manufacturing procedures Design and coordinate fabrication and implementation of process fixturing or gauging Analyze and map processes, assesses efficiency, and implements complex project activities Assist with part cost estimation Mentor Engineer I and II Support and comply with the company Quality System, ISO, and medical device requirements Qualifications Bachelor's Degree in Mechanical, Industrial, or other Engineering Science 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions Experience in an ISO13485/GMP environment Engineering experience with medical devices Manufacturing process design and validation Manufacturing equipment and fixture/gauge design Lean manufacturing experience Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict) DOE, SPC, FMEA, GMP, QSR Knowledge of statistical software Knowledge of materials and related processes Manufacturing automation, including electronic visual inspection 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.) Excellent communication and influencing skills High level of energy, personal accountability, and integrity Highly detail oriented; checks own work, keeps accurate records, organizes information effectively Ability to tolerate ambiguity, multiple priorities, and short deadlines Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint) What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.” “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.” “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.” We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $89,000.00 - USD $133,600.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $89k-133.6k yearly Auto-Apply 5d ago
  • Manufacturing Engineer III

    Cretex 4.0company rating

    Brooklyn Park, MN jobs

    Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at ********************** Manufacturing Engineer III Position Summary: The Manufacturing Engineer lll is responsible for leading the manufacturing process development of new products and implementation of new manufacturing processes.This position will also be responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes (such machining, packaging, welding, assembly, and molding). Responsibilities * Supports new product development team within Cretex Medical - working on projects that are aimed on bringing in new technology and manufacturing solutions to Cretex Medical * Responsible for creating manufacturing solutions for new projects either customer driven or internally driven * Interface with external and internal stakeholders of the project and take ownership of providing timely project updates, communicating schedule, risks, or delays. * Owner of process flow and implementation of all processes required for assigned project/product * Support implementation of new technology to Cretex Medical - may include vendor selection, equipment ordering, IQ/SAT, process development, and training. * Write Technical reports summarizing builds as well as maintain applicable work instructions. * Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology * Interface with quality and manufacturing to integrate new products or processes into the existing production area * Maintain and approve device routers and bill of materials * Maintain and approve manufacturing procedures * Design and coordinate fabrication and implementation of process fixturing or gauging * Analyze and map processes, assesses efficiency, and implements complex project activities * Assist with part cost estimation * Mentor Engineer I and II * Support and comply with the company Quality System, ISO, and medical device requirements Qualifications * Bachelor's Degree in Mechanical, Industrial, or other Engineering Science * 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions * Experience in an ISO13485/GMP environment * Engineering experience with medical devices * Manufacturing process design and validation * Manufacturing equipment and fixture/gauge design * Lean manufacturing experience * Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict) * DOE, SPC, FMEA, GMP, QSR * Knowledge of statistical software * Knowledge of materials and related processes * Manufacturing automation, including electronic visual inspection * 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.) * Excellent communication and influencing skills * High level of energy, personal accountability, and integrity * Highly detail oriented; checks own work, keeps accurate records, organizes information effectively * Ability to tolerate ambiguity, multiple priorities, and short deadlines * Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint) What is it like to work at Cretex Medical? We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical: * "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right." * "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it." * "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives." We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member. Pay Range USD $89,000.00 - USD $133,600.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $89k-133.6k yearly Auto-Apply 5d ago
  • Manufacturing Engineer II or III - NPI

    Cretex 4.0company rating

    Bloomington, MN jobs

    About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at ******************** and ********************** Responsibilities Manufacturing Engineer II or III - NPI Manufacturing Engineer II or III - NPI Ideal Candidate Profile QTS is currently seeking an energetic, responsive, and well-organized full-time Manufacturing Engineer. This position is within our New Product Introduction (NPI) team and will be responsible for developing and executing project plans to source, clean, assemble, package, label, and sterilize new medical devices. Manufacturing Engineer II or III - NPI Job Summary Develop, maintain, and improve procedures, documentation, tools, fixtures, and programs for end-of-line manufacturing of new and existing medical devices, based on external customer specifications. Work closely with Project Managers to assist with planning, cost estimation, and timeline development for defined projects. Interface with Quality to integrate new products or processes into the existing production area. Initiates and completes technical activities leading to new or improved products or design for manufacturability or processes for current and next generation programs and to meet strategic goals and objectives of the company. Analyze and solve problems from basic engineering principles, theories, and concepts. Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though the corrective and preventative action process. Perform and document process risk analysis (pFMEA) and implement risk mitigations. Develop and implement manufacturing process, business process, and product improvements with minimal supervisory guidance. Maintain and approve device routers and bill of materials. Develop manufacturing processes utilizing statistical process control as appropriate. Maintain and approve manufacturing procedures. Design and coordinate fabrication and implementation of process fixturing or gauging. Specify and lead qualification activities for new packaging and device components. Qualifications Manufacturing Engineer II / III - NPI Skills and Experience Bachelor's Degree in Mechanical, Industrial, or other Engineering Science. 3 - 7 years of experience in the medical device industry. Knowledge of Medical Device part / production process approval processes (PPAP) for medical devices. Experience with cleaning, sterilization, packaging, and/or sealing process validations for terminally sterilized medical devices. Experience working directly with suppliers in a regulated industry. Understanding of 3D CAD software (i.e., ProE, Unigraphics, SolidWorks, etc.). Excellent communication and influencing skills. High level of energy, personal accountability, and integrity. Detail oriented; checks own work, keeps accurate records, organizes information effectively. Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher). Clear and effective verbal and written communication skills. Ability to work in a fast-paced team environment. Ability to prioritize and communicate with stakeholders. Desirable Criteria & Qualifications Continuing Education; including participation in local chapters, associations, and/or organizations. Experience in an ISO13485/GMP environment. Engineering experience in a manufacturing facility. Manufacturing process design and validation. Manufacturing equipment and fixture/gauge design. Lean manufacturing, including statistical analysis. Manufacturing automation, including electronic visual inspection. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: “I would describe my coworkers as kind and friendly.” “… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!” “Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!” We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. Pay Range USD $75,000.00 - USD $136,200.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $75k-136.2k yearly Auto-Apply 42d ago
  • Manufacturing Engineer II or III - NPI

    Cretex 4.0company rating

    Bloomington, MN jobs

    About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at ******************** and ********************** Responsibilities Manufacturing Engineer II or III - NPI Manufacturing Engineer II or III - NPI Ideal Candidate Profile QTS is currently seeking an energetic, responsive, and well-organized full-time Manufacturing Engineer. This position is within our New Product Introduction (NPI) team and will be responsible for developing and executing project plans to source, clean, assemble, package, label, and sterilize new medical devices. Manufacturing Engineer II or III - NPI Job Summary * Develop, maintain, and improve procedures, documentation, tools, fixtures, and programs for end-of-line manufacturing of new and existing medical devices, based on external customer specifications. * Work closely with Project Managers to assist with planning, cost estimation, and timeline development for defined projects. * Interface with Quality to integrate new products or processes into the existing production area. * Initiates and completes technical activities leading to new or improved products or design for manufacturability or processes for current and next generation programs and to meet strategic goals and objectives of the company. * Analyze and solve problems from basic engineering principles, theories, and concepts. * Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though the corrective and preventative action process. * Perform and document process risk analysis (pFMEA) and implement risk mitigations. * Develop and implement manufacturing process, business process, and product improvements with minimal supervisory guidance. * Maintain and approve device routers and bill of materials. * Develop manufacturing processes utilizing statistical process control as appropriate. * Maintain and approve manufacturing procedures. * Design and coordinate fabrication and implementation of process fixturing or gauging. * Specify and lead qualification activities for new packaging and device components. Qualifications Manufacturing Engineer II / III - NPI Skills and Experience * Bachelor's Degree in Mechanical, Industrial, or other Engineering Science. * 3 - 7 years of experience in the medical device industry. * Knowledge of Medical Device part / production process approval processes (PPAP) for medical devices. * Experience with cleaning, sterilization, packaging, and/or sealing process validations for terminally sterilized medical devices. * Experience working directly with suppliers in a regulated industry. * Understanding of 3D CAD software (i.e., ProE, Unigraphics, SolidWorks, etc.). * Excellent communication and influencing skills. * High level of energy, personal accountability, and integrity. * Detail oriented; checks own work, keeps accurate records, organizes information effectively. * Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher). * Clear and effective verbal and written communication skills. * Ability to work in a fast-paced team environment. * Ability to prioritize and communicate with stakeholders. Desirable Criteria & Qualifications * Continuing Education; including participation in local chapters, associations, and/or organizations. * Experience in an ISO13485/GMP environment. * Engineering experience in a manufacturing facility. * Manufacturing process design and validation. * Manufacturing equipment and fixture/gauge design. * Lean manufacturing, including statistical analysis. * Manufacturing automation, including electronic visual inspection. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: * "I would describe my coworkers as kind and friendly." * "… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!" * "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!" We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. Pay Range USD $75,000.00 - USD $136,200.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************
    $75k-136.2k yearly Auto-Apply 41d ago
  • Manufacturing Engineer II/III

    Eyepoint Pharmaceuticals 4.5company rating

    Northbridge, MA jobs

    Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our: * focus on science and innovation, we aim to offer a lifetime of clearer vision * commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases * Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases. We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. EyePoint is seeking a motivated Manufacturing Engineer II/III with excellent interpersonal skills to join our team. This person will be responsible for process sustaining and improvement of all component, device, and packaging related projects. This position requires the application of continuous improvement, equipment oversight, trending, layout plans, testing, data analysis and report writing to resolve and improve manufacturing efficiencies. Candidate must be able to effectively collaborate with internal R&D, Quality, Regulatory and Operations departments and with external vendors and suppliers to deliver against project timelines and maintain process sustaining activities. The ideal candidate possesses the ability to develop credibility and trust as a technical leader to contribute to the company's growth, productivity, and innovation. This position is reporting to the Director, Manufacturing and Technical Operations and is located at our Northbridge, MA facility. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual responsibilities * Ability to identify and lead engineering related projects to continuously review and revise processes in production to enhance quality, yield, and efficiency. * Author and execute equipment commissioning and qualification protocols and reports. * Apply lean manufacturing methodologies to reduce costs and increase efficiency. * Oversee production operations and troubleshoot technical issues in cleanroom environments. * Coordinate and communicate engineering related activities with product vendors and suppliers. * Support the design, development, and optimization of processes, including upstream and downstream operations. * Troubleshoot process-related issues and lead quality investigations and implementation of corrective actions. * Create, customize and implement tooling and fixturing to increase efficiency and product quality in manufacturing. * Generate and maintain process documentation, including standard operating procedures, work instructions, and batch records. * Work in cross-functional teams and work with other departments to implement changes. * Serve as subject matter expert from functional area. * Ensure compliance with GMP and regulatory standards. Qualifications Primary skills and knowledge required include, but are not limited to the following: * Strong mathematical and statistical abilities to gather data and calculate optimal output. * Proficiency with equipment, facility, and process validations. * Analytical skills to analyze process steps and seek optimization. * Mechanical skills to oversee the use of equipment used in production. * Familiarity with engineering software like AutoCAD and SOLIDWORKS. * Proficient in Microsoft Applications (Word, Excel, PowerPoint, Visio) * Strong commitment to compliance and ethical standards. * Proficiency with cGMP regulations and quality management systems. Other Requirements: * Proactive and creative problem solver who is highly organized and detail oriented. * Strong listening and communication skills -both written and verbal. * Ability to contribute to development of project timelines. Ability to complete tasks within agreed timelines and resources through manager guidance. * Adaptability, resiliency, and ability to thrive in fast paced organization. * Ability to influence and drive organizational success. * Exceptional project management skills; proficiency in tracking processes and projects. * A demonstrated willingness to collaborate cross-functionally and build relationships on projects of diverse scope. * Experience in life sciences, medical devices, or regulated industry preferred. * Ability to lift up to 25 pounds on occasion. Level of Education Required: * Bachelor of Science Preferred Field of Study: Engineering Number of Years of Experience in the Function and in the Industry: * A minimum of 3-5 years of experience in the medical device and/or pharmaceuticals industry. Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to improving the lives of patients with serious retinal diseases by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Onsite Min USD $85,490.00/Yr. Max USD $128,750.00/Yr.
    $85.5k-128.8k yearly Auto-Apply 7d ago
  • Manufacturing Engineer III

    PCI Pharma Services 4.1company rating

    San Diego, CA jobs

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. SUMMARY: Maintain and provide input to specify manufacturing equipment supporting biopharmaceutical manufacturing, including aseptic filling. Supports end users in specifying, diagnosing, repairing, and upgrading manufacturing systems, including completion of GMP-related documentation. ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED: Maintain and troubleshoot manufacturing equipment. Update manufacturing systems. Provide input and author URS, FDS, SAT, I/O/PQ, and SOP documents. Document changes to systems per change management procedures. Research new technologies and make recommendations. Travel between facilities to support all functional areas. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. EDUCATION AND EXPERIENCE: High School Diploma or equivalent required. Bachelor's degree preferred (Bioengineering, ChE, EE, IE, ME, or similar). Minimum 5 - 8 years of relevant experience. Minimum 4 years of cGMP experience. Broad understanding of filling, facility and utility systems. Well-developed hands-on experience with manufacturing equipment. Understanding of manufacturing systems and GMP requirements. The base salary hiring range for this position is ($106,800 - $120,150) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $106.8k-120.2k yearly Auto-Apply 43d ago
  • Manufacturing Engineer III

    PCI Pharma Services 4.1company rating

    San Diego, CA jobs

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **SUMMARY:** Maintain and provide input to specify manufacturing equipment supporting biopharmaceutical manufacturing, including aseptic filling. Supports end users in specifying, diagnosing, repairing, and upgrading manufacturing systems, including completion of GMP-related documentation. **ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:** + Maintain and troubleshoot manufacturing equipment. + Update manufacturing systems. + Provide input and author URS, FDS, SAT, I/O/PQ, and SOP documents. + Document changes to systems per change management procedures. + Research new technologies and make recommendations. + Travel between facilities to support all functional areas. + Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. + Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. + Embodies PCI Pharma Service's cultural values and aligns daily actions with department goals and company culture. **EDUCATION AND EXPERIENCE:** + High School Diploma or equivalent required. + Bachelor's degree preferred (Bioengineering, ChE, EE, IE, ME, or similar). + Minimum 5 - 8 years of relevant experience. + Minimum 4 years of cGMP experience. + Broad understanding of filling, facility and utility systems. + Well-developed hands-on experience with manufacturing equipment. + Understanding of manufacturing systems and GMP requirements. The base salary hiring range for this position is ($106,800 - $120,150) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). \#LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
    $106.8k-120.2k yearly 45d ago
  • Manufacturing Engineer

    Eaton Aerospace 4.0company rating

    Orchard Park, NY jobs

    Eaton's IS AER MSD division is currently seeking a Manufacturing Engineer. The expected annual salary range for this role is $67500.0 - $99000.0 a year. Please note the salary information shown above is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as market and business considerations. What you'll do: Eaton's Aerospace Division is seeking a Manufacturing Engineer, at our Orchard Park, NY facility. The Manufacturing Engineer position will support manufacturing cells of new and existing products. Responsible for managing process documents, tooling and fixturing for programs, driving continuous improvement by utilizing Lean Six Sigma tools, performing ergonomic assessments and providing typical Manufacturing Engineering rigor required for Aerospace Industry product realization. Essential Duties and Responsibilities include the following. Other duties may be assigned. • Learn and implement Safety, Ergonomics, and Management of Change activity in support of site safety goals. • Generate and maintain Manufacturing Processes and Manufacturing Work Instructions • Identify when/where there is a need for standard or special gauging, and special equipment/tooling for production • Drive First Pass Yield (FPY) and Overall Process Effectiveness (OPE) improvement • Work with a multifunctional team including Continuous Improvement and the Tool Design Group to develop tooling and fixtures to improve work flow, though-put, and quality • Provide timely support in resolving manufacturing issues • Assist in developing Work Cell Design, Integration and Validation • Utilize Lean Six Sigma tools to reduce waste and variation in processes focused on improving KPIs • Support 5S and visual management efforts in manufacturing areas Qualifications: Basic Qualifications: • Bachelors Degree, in Engineering or Industrial/OperationsTechnology, from an accredited institution. • Minimum of 1 year of professional experience, in a Manufacturing environment. • This position requires use of information or access to hardware which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. "Green Card Holder"), Political Asylee or Refugee. • Candidates must be legally authorized to work in the United States without company sponsorship now or in the future. • Relocation is not provided - candidates must reside within a 50 mile radius of the Eaton Orchard Park, NY facility. Preferred Qualifications: • Experience in Developing and Supporting Electrical / Electro - mechanical product manufacture processes • Practioner of Lean manufacturing and Visual Control implementations • Experience in developing tooling used in the support Assembly of Mechanical and Electrical Products • Understanding of Design for Manufacture and Assembly (DFMA) principals • Knowledge of PFMEAs (Failure Modes and Effects Analysis - within Manufacturing) • Experience with Continuous Improvement and root cause problem solving activities • Ability to work in a multi project, team environment • Organizational, communication, leadership, personal computing, performance management skills We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law. Eaton considers qualified applicants regardless of criminal histories, consistent with local laws. To request a disability-related reasonable accommodation to assist you in your job search, application or interview process, please call us at 1-800-###-#### to discuss your specific need. Only accommodation requests will be accepted by this phone number. We know that good benefit programs are important to employees and their families. Eaton provides various Health and Welfare benefits as well as Retirement benefits, and several programs that provide for paid and unpaid time away from work. Click here for more detail: Eaton Benefits Overview. Please note that specific programs and options available to an employee may depend on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
    $67.5k-99k yearly 9d ago
  • Engineer I, Commercial Manufacturing

    Xeris Pharmaceuticals 4.2company rating

    Chicago, IL jobs

    Support all functions of the pharmaceutical supply chain for all commercial products. Ensure product is manufactured in a quality manner under cGMP's and available for sale based on commercial forecasts. Ensure inventory and supplies are available at every point within the supply chain to meet production schedule. The Engineer I will provide a broad understanding of the manufacturing supply chain from drug substance manufacturing through commercial packaging and working within a matrixed organization. The Engineer I / II will assist with planning and execution of routine technical assignments and demonstrates firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing. Responsibilities Support manufacturing operations at Contract sites (CMOs, etc.). Responsibilities include, but may not be limited to: Assist in commercial production planning Support colleagues in the day-to-day manufacturing activities on a routine basis to ensure commercial supply Helps with logistics activities such as quotes, invoices, inventory management and shipment of products and intermediates Frequently interacts with other functional peer group managers and CMOs to support the commercial manufacturing or development activities Accurately collects / performs data mining and appropriately records / trends observations Aid in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations Collaborate with other functions such as Device Development, Quality Assurance, Quality Control, Regulatory, and Finance Qualifications Bachelor's degree required, master's degree preferred in Engineering or relevant Supply Chain, Scientific, or equivalent degree with 3 to 5 years of experience working in pharmaceuticals Minimum 3 years of experience in a GMP pharmaceutical/biopharmaceutical environment with sterile drug product manufacturing Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management Skills preferred: Data Management, Manufacturing/Supply Chain background Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel may be required up to 20% at times to CMOs and CSPs location. Periodic overnight travel may occur for work. This position is based in Xeris' Chicago office. A minimum of four days per week on site is required. On site requirement may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $80,000 to $110,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
    $80k-110k yearly Auto-Apply 11d ago
  • Manufacturing Engineer

    Hanwha Aerospace USA 4.1company rating

    Cheshire, CT jobs

    Manufacturing Engineer - Exempt Hanwha Aerospace USA has long been recognized as a leader in the development and supply of flight critical Aerospace/Defense components and assemblies. Operating out of four state-of-the-art facilities located in Connecticut, Hanwha Aerospace USA offers growth and career development opportunities to enrich your talents. This challenging positon is a great opportunity for the right candidate to become a part of a dedicated team of aerospace manufacturing professionals. This position will be responsible for performing general engineering tasks that optimize processing capabilities of the facility through process development and verification. The Manufacturing Engineer will analyze process flow, developing performance enhancements and monitoring production results. Location: Cheshire, CT Reports to: Engineering Manager Essential Duties & Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform. Create and / or improve on systems that optimize the efficiency of material flow throughout the facility. Develop the most efficient and cost effective manufacturing process, and sequence of production operations from blueprints, quality documents, and purchase orders. Coordinate production processes by creating operation sheets and providing all manufacturing related information. Create material process requisitions with technical data requirements for special manufacturing processes. Develop most effective solutions to production and quality problems that are related to material, production processes and tools. Manage product and process engineering related activities during the development stage from raw material to finished product Research and develop process sheets with proper work instructions for the operators, inspectors and shipping. Will act as a liaison for the shop process development, integrating with management, shop personnel, purchasing, production control, vendors and customers to make the job as productive as possible. Implement all Engineering Changes from the Customer to the process sheets, programs, etc. Interact with various internal functions to provide manufacturing engineering support for production. Participate in Root Cause Analysis and implementation of Corrective Actions. Initiate and lead optimization projects to improve quality outcomes, reduce production costs, and shorten cycle time. Build trust and confidence with customers to resolve engineering, manufacturing, and quality issues. Participate in training as required 5-10% Domestic Travel required Requirements: Must be a “US Person” as defined by US Government and able to work without restriction with ITAR related data. Bachelor's Degree in Mechanical Engineering or other related field required 2+ years experience as an Engineer in a manufacturing environment Must have the ability to work with CAD Systems such as Solidworks, NX 7.5 and above, Microsoft Office to generate work instructions / process sheets. Desire for practical and tangible ‘hands-on' work in a manufacturing environment. Knowledge/experience in the machining of nickel and titanium based alloys preferred (i.e. milling, turning, broaching, and special processes) Demonstrated record or desire of same for the self-directed management of multiple tasks in a high-tempo manufacturing environment. An determined commitment to overcome challenges in order to resolve issues and accomplish both company and personal objectives. Must possess excellent skills in blueprint reading and interpretation, have the ability to understand customer requirements and specifications. Must be able to read, write, understand, and speak English at a functional level. AAP Statement Hanwha Aerospace USA is an Equal Opportunity Employer. We conform to all the laws, statutes, and regulations concerning equal employment opportunities and affirmative action. We strongly encourage women, minorities, individuals with disabilities, and veterans to apply to all of our job openings. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability status, Genetic Information & Testing, Family & Medical Leave, Sexual Orientation, and Gender Identity or Expression, protected veteran status, or any other characteristic protected by law. We prohibit Retaliation against individuals who bring forth any complaint, orally or in writing, to the employer or the government, or against any individuals who assist or participate in the investigation of any complaint or otherwise oppose discrimination. *Subject to change with or without notice*
    $72k-94k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Engineer

    Hanwha Aerospace USA LLC 4.1company rating

    Cheshire, CT jobs

    Job Description Manufacturing Engineer - Exempt Hanwha Aerospace USA has long been recognized as a leader in the development and supply of flight critical Aerospace/Defense components and assemblies. Operating out of four state-of-the-art facilities located in Connecticut, Hanwha Aerospace USA offers growth and career development opportunities to enrich your talents. This challenging positon is a great opportunity for the right candidate to become a part of a dedicated team of aerospace manufacturing professionals. This position will be responsible for performing general engineering tasks that optimize processing capabilities of the facility through process development and verification. The Manufacturing Engineer will analyze process flow, developing performance enhancements and monitoring production results. Location: Cheshire, CT Reports to: Engineering Manager Essential Duties & Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform. Create and / or improve on systems that optimize the efficiency of material flow throughout the facility. Develop the most efficient and cost effective manufacturing process, and sequence of production operations from blueprints, quality documents, and purchase orders. Coordinate production processes by creating operation sheets and providing all manufacturing related information. Create material process requisitions with technical data requirements for special manufacturing processes. Develop most effective solutions to production and quality problems that are related to material, production processes and tools. Manage product and process engineering related activities during the development stage from raw material to finished product Research and develop process sheets with proper work instructions for the operators, inspectors and shipping. Will act as a liaison for the shop process development, integrating with management, shop personnel, purchasing, production control, vendors and customers to make the job as productive as possible. Implement all Engineering Changes from the Customer to the process sheets, programs, etc. Interact with various internal functions to provide manufacturing engineering support for production. Participate in Root Cause Analysis and implementation of Corrective Actions. Initiate and lead optimization projects to improve quality outcomes, reduce production costs, and shorten cycle time. Build trust and confidence with customers to resolve engineering, manufacturing, and quality issues. Participate in training as required 5-10% Domestic Travel required Requirements: Must be a “US Person” as defined by US Government and able to work without restriction with ITAR related data. Bachelor's Degree in Mechanical Engineering or other related field required 2+ years experience as an Engineer in a manufacturing environment Must have the ability to work with CAD Systems such as Solidworks, NX 7.5 and above, Microsoft Office to generate work instructions / process sheets. Desire for practical and tangible ‘hands-on' work in a manufacturing environment. Knowledge/experience in the machining of nickel and titanium based alloys preferred (i.e. milling, turning, broaching, and special processes) Demonstrated record or desire of same for the self-directed management of multiple tasks in a high-tempo manufacturing environment. An determined commitment to overcome challenges in order to resolve issues and accomplish both company and personal objectives. Must possess excellent skills in blueprint reading and interpretation, have the ability to understand customer requirements and specifications. Must be able to read, write, understand, and speak English at a functional level. AAP Statement Hanwha Aerospace USA is an Equal Opportunity Employer. We conform to all the laws, statutes, and regulations concerning equal employment opportunities and affirmative action. We strongly encourage women, minorities, individuals with disabilities, and veterans to apply to all of our job openings. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability status, Genetic Information & Testing, Family & Medical Leave, Sexual Orientation, and Gender Identity or Expression, protected veteran status, or any other characteristic protected by law. We prohibit Retaliation against individuals who bring forth any complaint, orally or in writing, to the employer or the government, or against any individuals who assist or participate in the investigation of any complaint or otherwise oppose discrimination. *Subject to change with or without notice*
    $72k-94k yearly est. 3d ago
  • Manufacturing Engineer

    CMI Group Aerospace & Defense 4.5company rating

    Phoenix, AZ jobs

    (Aerospace & Defense Manufacturing) Due to the nature of work performed within our facilities, U.S. citizenship or Valid Permanent Resident status is required. Responsibilities: Develop detailed manufacturing process plans for new products Improve manufacturing process plans and equipment for existing products Verify and update existing manufacturing process plans for subsequent product lots Design work-holding fixtures for CNC machining and related production processes Troubleshoot manufacturing issues with demonstrated urgency Collaborate and coordinate with programming, production, and management Maintain high product quality and manufacturing yield Basic Qualifications: Engineering degree or equivalent experience Comprehensive knowledge of and solid experience with CNC machining 3D CAD experience - Solidworks strongly preferred Experience with working as a supplier for large aerospace manufacturers Experience with creating comprehensive process routers and manufacturing drawings Familiar with ancillary processing of metals (i.e. heat treat, nitride, anodize, plating, etc.) Ability to quickly and accurately interpret blueprints and associated technical specifications, strong GD&T interpretation Ability and willingness to work under pressure, manage competing demands and tight deadlines Strong operational instruction writing and editing skills Ability to work independently and in a team, effectively Excellent verbal, interpersonal, and written communication skills Lean manufacturing skills and experience are a plus Team oriented company with top paying wages and benefits in the valley in regards to the Aerospace Industry. To qualify for consideration, all candidates must be able to work in a fast paced, high-demand, quality environment. All candidates must also have sufficient verbal and written communication skills as well as good problem solving skills. CMI Group is equal opportunity employer providing competitive wages and benefits. Medical, dental, vision, disability and life insurance available. 401(k) with company match. This is an equal opportunity employer and will not discriminate against any employee or applicant due to age, race, disability, veteran status, religion, sexual orientation, gender or any other protected classification. VEVRAA federal subcontractor. This company provides provide equal employment opportunities to applicants without regard to race, color, religion, gender, age, national origin, or disabilities in compliance with federal and state laws including: The Civil Rights Act of 1964 as Amended Age Discrimination Act of 1967 as Amended Rehabilitation Act of 1973 Vietnam Era Veterans Readjustment Act of 1974 Americans with Disabilities Act Amendment Act of 2009 (ADAAA) The Wagner-Peyser Act as Amended. The Workforce Innovation and Opportunity Act Fair Credit Reporting Act, 15 U.S.C. 1681 et seq
    $75k-98k yearly est. 60d+ ago
  • Manufacturing Engineer III

    Diality 3.9company rating

    Irvine, CA jobs

    The purpose of the Manufacturing Engineer III is to assist in manufacturing engineering activities including design transfer, process validation, and design for manufacturability. Responsibilities: Other duties as assigned or required Works under moderate supervision. Can work independently or within a team on larger, moderately complex projects or assignments. Work with the Design Team to ensure manufacturability and effective design transfer of new products to commercialization Develop, document, evaluate, monitor, and improve manufacturing processes Review technical drawings such as mechanical design and tolerance stack-ups Conduct risk analyses to ensure safe design/processes, write pFMEA documents Represents the operations group in projects to ensure manufacturability and serviceability are incorporated into a design plan Work closely with vendors and contract manufacturers on technical and operational issues Assist with design transfer activities Design and create tooling and fixtures as needed for the manufacturing line, including using common rapid prototyping tools, and conventional machining, as well as incorporating basic electronics and programming as needed Requirements: 10 years minimum related work experience Four-year engineering degree At least 2 years of design transfer experience is a mus Biomedical or Mechanical Engineering degree a plus Knowledge and experience of DOE Knowledge of mechanical drawings including GD&T Experience with IQ/OQ/PQ Familiarity with thermodynamic, electromechanical, electrical, and chemical systems Excellent communication skills with all levels within and outside of the organization Previous experience with design transfer to contract manufacturers a plus Good documentation skills Demonstrated ability to work on problems of a complex scope where analysis of situations or data involves multiple competing factors. Experience with system design architecture preferably Python (preferred) Medical Device experience a plus Experience in Lean/six sigma Ability to verbally communicate ideas and issues effectively to other Product development lifecycle knowledge is required Experience with design transfer and on-going manufacturing of single-use sterile disposables and/or complex electro-mechanical devices Understanding of Medical Device design/process control process is desired Works well with other engineers in a collaborative, fast-paced goal-driven environment Founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission. Solidworks/PDM Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to comprehend and apply mathematic and descriptive statistic principles to the degree required to perform the job based upon job requirements.
    $75k-97k yearly est. 60d+ ago
  • Manufacturing Engineer

    Aphena Pharma Solutions 4.2company rating

    Easton, MD jobs

    Job Details Liquid and Topicals Division MD - Easton, MD $80000.00 - $85000.00 SalaryDescription Qualifications
    $80k-85k yearly 54d ago
  • Manufacturing Engineer

    Composite Motors 3.9company rating

    Florida jobs

    Position Overview: This position is created for a proactive and detail-oriented Manufacturing Engineer to bridge the gap between Engineering and Production in our ISO 13485-compliant medical device manufacturing environment. This role is responsible for developing and maintaining robust manufacturing processes, documentation, and the utilization of our quality systems to ensure product reliability, regulatory compliance, and operational efficiency. Essential Job Functions: Process Development & Documentation: Create and maintain manufacturing routers, work instructions, and standard operating procedures (SOPs). Develop and update process flow charts and PFMEAs Lead and support process validations (IQ/OQ/PQ) in accordance with ISO 13485 and FDA requirements. Conduct First Article Inspections (FAI) and ensure proper documentation and traceability. Coordinate with Quality to develop and maintain Production Part Approval Process documentation. Evaluate existing tools and fixtures for efficacy. Create new tools and fixtures to support production utilizing Solid Works when necessary. Inspection and Quality Control Design and implement incoming inspection procedures for raw materials and components. Monitor and analyze non-conforming material, lead root cause investigations, and define rework processes. Support and participate in Corrective and Preventive Actions (CAPA). Conduct and analyze Statistical Process Control (SPC) studies to monitor and improve process performance. Training and Support Train production personnel on new and revised manufacturing procedures and equipment. Provide technical support to resolve production issues and improve process capability. Continuous Improvement Collaborate with cross-functional teams to identify and implement process improvements. Collaborate with cross-functional teams to reduce waste and improve efficiency. Required Qualifications: Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or related field. Minimum of 3-5 years of experience in a regulated manufacturing environment, preferably medical devices. Strong working knowledge of ISO 13485. Experience with process validation, FAI, PFMEA, SPC, and PPAP documentation. Proficiency in CAD software, ERP systems, and Microsoft Office Suite. Excellent documentation, communication, and organizational skills. Preferred Skills: Familiarity with risk management tools and statistical analysis software (e.g., Minitab).
    $61k-78k yearly est. 60d+ ago
  • Manufacturing Engineer I

    Zoetis 4.9company rating

    Durham, NC jobs

    The Manufacturing Engineer I will provide sustaining engineering activities in the Zoetis Diagnostic & Biodevice (Dx/BD) platform. Assignments may include, but are not limited to, support of manufacturing operations, process characterization and optimization, change control projects, and engineering support of non-conformances and CAPAs. The engineer will provide support for strategic capital projects under the direction of a project lead. POSITION RESPONSIBILITIES Participate in projects relating to the development and optimization of production processes, including plant design, process equipment/workflows, material handling and automation. Provide engineering support to maintain production equipment and tooling. Support product variant projects to transfer product designs from development to commercial manufacture. Evaluate existing manufacturing processes for improvements in capacity, efficiency and product quality in alignment with business needs. Support activities to validate new or modified equipment and processes. Conduct testing of alternate materials to study their impact to product performance. Provide engineering support to troubleshoot and assess root cause for quality deviations that occur during manufacturing operations. Support continuous improvement projects. Create/update Standard Operating Procedures and manufacturing Work Instructions. Prepare Material Specification Sheets and manufacturing Bill of Materials. EDUCATION AND EXPERIENCE Education: BS in a field of engineering (Mechanical or Electrical Engineering preferred) Experience: > 5 years experience in a regulated manufacturing environment, preferably in the diagnostics or biodevice industries. Functional understanding of common electromechanical components. Experience with automated control systems. Proven experience in the application of engineering principles to the design and improvement of manufacturing processes. Relevant experience in the design and fabrication of production tooling. Experience in optimizing production workflows in increase productivity and reduce waste. TECHNICAL SKILLS and COMPETENCIES Able to quickly learn new processes Proven ability to identify, assess and solve complex problems Able to analyze process data for trends and effects Application of Lean 6-Sigma tools Experienced in AutoCAD and SolidWorks Understanding of cGMP Able to work in a team and independently Attention to detail Good written and oral communication skills Proficient in English Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $61k-82k yearly est. Auto-Apply 5d ago
  • Manufacturing Engineer I

    Zoetis 4.9company rating

    Durham, NC jobs

    The Manufacturing Engineer I will provide sustaining engineering activities in the Zoetis Diagnostic & Biodevice (Dx/BD) platform. Assignments may include, but are not limited to, support of manufacturing operations, process characterization and optimization, change control projects, and engineering support of non-conformances and CAPAs. The engineer will provide support for strategic capital projects under the direction of a project lead. POSITION RESPONSIBILITIES * Participate in projects relating to the development and optimization of production processes, including plant design, process equipment/workflows, material handling and automation. * Provide engineering support to maintain production equipment and tooling. * Support product variant projects to transfer product designs from development to commercial manufacture. * Evaluate existing manufacturing processes for improvements in capacity, efficiency and product quality in alignment with business needs. * Support activities to validate new or modified equipment and processes. * Conduct testing of alternate materials to study their impact to product performance. * Provide engineering support to troubleshoot and assess root cause for quality deviations that occur during manufacturing operations. * Support continuous improvement projects. * Create/update Standard Operating Procedures and manufacturing Work Instructions. * Prepare Material Specification Sheets and manufacturing Bill of Materials. EDUCATION AND EXPERIENCE Education: * BS in a field of engineering (Mechanical or Electrical Engineering preferred) Experience: * > 5 years experience in a regulated manufacturing environment, preferably in the diagnostics or biodevice industries. * Functional understanding of common electromechanical components. * Experience with automated control systems. * Proven experience in the application of engineering principles to the design and improvement of manufacturing processes. * Relevant experience in the design and fabrication of production tooling. * Experience in optimizing production workflows in increase productivity and reduce waste. TECHNICAL SKILLS and COMPETENCIES * Able to quickly learn new processes * Proven ability to identify, assess and solve complex problems * Able to analyze process data for trends and effects * Application of Lean 6-Sigma tools * Experienced in AutoCAD and SolidWorks * Understanding of cGMP * Able to work in a team and independently * Attention to detail * Good written and oral communication skills * Proficient in English Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
    $61k-82k yearly est. Auto-Apply 4d ago

Learn more about Takeda Pharmaceuticals U.S.A., Inc. jobs

Most common jobs at Takeda Pharmaceuticals U.S.A., Inc.

View all jobs