We anticipate the application window for this opening will close on - 13 Aug 2025
Position Description:
Principal Manufacturing Engineer for Medtronic, Inc located in Danvers, MA. Responsible for design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling. Design arrangement of machines within plant facilities to ensure most efficient and productive layout. Design sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance. Work to develop various validation protocols, test methods and test fixtures. Navigate various risk activities to include PFMEA (Process Failure Mode Effect Analysis) and DFMEA (Design Failure Mode & Effects Analysis). Navigate complex industry and government regulations to include ISO quality system - ISO 9001, ISO 14971, ISO13485, FDA QSR (Quality Systems Regulation) Part 820 and relevant international standards. Coordinate process validations using IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) and CAPA (corrective and preventative actions). Develop manufacturing processes and equipment at contract manufacturers and internal operations facilities. Utilize processes including Root cause and defect analysis, 5S, Statistical Process Control (SPC), and Process Capabilities for quality outcomes. Utilize various industry systems and CAD software packages. Conduct statistical analyses and work with policy stakeholders regarding risk-based sampling methodologies. Utilize Lean manufacturing and Six Sigma methodologies, incorporating GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices). *Relocation assistance not available for this position. #LI-DNI.
Basic Qualifications:
Master's Degree in Manufacturing, Mechanical, Industrial, or Biomedical Engineering, or related engineering field, and five (5) years of experience as a Manufacturing engineer or related occupation. Must possess a minimum of five (5) years of experience with each of the following: Developing validation protocols, test methods and test fixtures; PFMEA & DFMEA; ISO 9001, ISO 14971, ISO13485, and FDA QSR Part 820; IQ/OQ/PQ and CAPA; Developing manufacturing processes and equipment; Root cause and defect analysis, 5S, SPC, and Process Capabilities; Lean manufacturing, Six Sigma methodologies, GDP and GMP; and CAD software. Relocation assistance not available for this position.
Salary: $130,600 to $177,600 per year
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\name=signon&co\num=30601&co_affid=medtronic)
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email AskHR@medtronic.com
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