Product Engineer II

Medtronic; North Haven (CT); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) plan with employer match

Paid time off

Job summary

Medtronic in North Haven, CT, is seeking a Product Engineer in the Released Product Engineering (RPE) group. This role focuses on sustaining engineering for stapling devices, collaborating with Manufacturing, Quality, Regulatory Affairs and suppliers to maintain performance and supply while ensuring compliance.

The position offers a hybrid work model (on-site four days per week) with minimal travel and opportunities to contribute to design changes, process improvements, and regulatory compliance

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 2 years of relevant experience.
• Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP.
• Experience with statistical analysis tools (Minitab) and DOE.
• Knowledge of DFA/DFM, GD&T and design documentation.
• CAPA/root cause investigations and quality tools.
• Travel up to 10%.
• BS earned outside the United States must meet requirements of 8 CFR 214.2(h)(4)(iii)(A).

Responsibilities

• Evaluate and implement product and process changes for stapling devices.
• Develop design and test documentation and support investigations.
• Collaborate with Manufacturing, Quality, Regulatory Affairs and suppliers.
• Resolve product, supplier and manufacturing issues while maintaining compliance.
• Lead sub projects and provide primary technical contributions.
• Adhere to design controls, risk analysis and SOPs; prepare reports and analyses.

Job description

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

The product engineering II supports sustaining engineering activities for stapling products in the Released Product Engineering (RPE) group within the CSI. This role is responsible for evaluating and implementing product and process changes, developing design and test documentation, supporting investigations, and collaborating across functions to resolve product, supplier, and manufacturing issues while maintaining compliance with medical device regulations and design control requirements.

Within the RPE group, this role focuses on sustaining engineering for commercially released products, including Open, Laparoscopic stapling devices and GYN products. The team partners closely with Manufacturing, Quality, Regulatory Affairs, and suppliers to maintain product performance, quality, compliance, and continuity of supply throughout the product lifecycle. This position is based in North Haven, CT and follows a hybrid work model requiring on-site presence four days per week. Travel is expected to be minimal and may include visits to manufacturing sites or suppliers as needed.

Responsibilities may include the following and other duties may be assigned. Represents the organization in providing imaginative, thorough, practical solutions to difficult technical issues associated with specific products that are consistent with the organizations objectives. Anticipates and identifies problems of a unique and challenging nature, including those requiring research and/or analysis to identify. Work on highly complex technical problems and provide solutions that are highly innovative and ingenious to a broad range of problems. Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements. Reviews and evaluates development protocols, results and conclusions. Demonstrates an understanding of functional and customer requirements. Collaborates with peers to develop appropriate testing to verify product meets requirements and sets appropriate specifications to ensure product reliability and manufacturability. Investigates customer complaints on existing products and helps to determine root cause of complaint and corrective actions if necessary. Incorporates required regulatory standards in developmental and/or sustaining engineering projects. Contributes inventions, new designs and techniques associated with the completion of specific projects. Provides primary technical contributions and or may lead sub projects. Adheres to safety policy and procedures. Conducts project management tasks and documentation with design controls and risk analysis in accordance with established SOPs. Prepares reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, and customers.

Must Have: Minimum Requirements Bachelors degree required Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience Nice to Have BS in Engineering Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP Experience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis Process V&V, IQ, OQ, PQ and TMV Knowledge of DFMEA and PFMEA, process mapping and critical to quality reviews Demonstrated knowledge DFA/DFM, design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&T PTC Creo or Solidworks CAPA, root cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts Experience or knowledge of engineering drawings and GD&T Traveling maybe required-up 10%. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$80,000.00 - $120,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertaining solely to candidates hired within the United States (local market compensation and benefits will apply for others). 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
• 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)
• 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

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.

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 other: 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