Sr Product Engineer

Medtronic • North Haven, CT

23h

About The Position

The Sr Product Engineer supports Released Product Engineering (RPE) activities for surgical stapling devices. RPE is responsible for product design, Corrective Actions and Preventive Actions (CAPA), and product enhancements that support product sustainability and improve clinical performance. The engineer leads or champions initiatives from concept through implementation, presents initiative status to management, and provides leadership and mentorship to junior engineers.

The role addresses complex technical issues involving medical devices, develops and evaluates designs, verifies products against internal and external requirements, investigates customer complaints, and incorporates applicable regulatory standards. It also involves project management and documentation under design controls and risk-analysis processes, along with preparing analytical reports and presentations for peers, executives, and customers.

Requirements

• Bachelor’s degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of experience.
• For baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Unrestricted U.S. work authorization at the time of hire and for the duration of employment; sponsorship is not offered for roles below Principal level.
• Ability to interpret a variety of technical information and work with abstract and concrete variables.
• Good communication and teamwork skills.
• In-depth knowledge and application of Microsoft Office.

Nice To Haves

• Mechanical design experience.
• Knowledge and understanding of the design change control process.
• DRM, DFSS, and/or Six Sigma training or experience.

Responsibilities

• Lead or champion engineering initiatives from concept through implementation and present their status to management.
• Provide leadership and mentorship to junior engineers.
• Develop imaginative, practical solutions to difficult technical issues associated with specific products.
• Anticipate and investigate complex technical problems, including conducting research or analysis as needed.
• Work on highly complex technical problems and provide innovative solutions.
• Collaborate with peers to develop testing that verifies products meet internal and external customer requirements.
• Review and evaluate development protocols, results, and conclusions.
• Apply understanding of functional and customer requirements to product development and sustaining work.
• Set appropriate specifications to support product reliability and manufacturability.
• Investigate customer complaints about existing products, help determine root causes, and identify corrective actions when necessary.
• Incorporate required regulatory standards into developmental and sustaining engineering projects.
• Contribute inventions, designs, and techniques to specific projects; provide primary technical contributions and potentially lead subprojects.
• Conduct project-management tasks and prepare documentation using design controls and risk analysis in accordance with established SOPs.
• Prepare analytical and interpretative reports, presentations, and spreadsheets for peers, executives, and customers.
• Design and redesign medium- to high-complexity medical devices and subsystems.
• Test and optimize designs through experiments and evaluations, including numerical verification such as FEA and tolerance analysis.
• Prepare documentation in accordance with relevant internal SOPs and design control requirements.
• Interact with suppliers and participate in Design for Manufacturability (DFM) and Design for Assembly (DFA) activities to assess component and assembly manufacturability.
• Participate in FMEA and follow up on generated recommendations.
• Participate in pre-clinical in vivo labs, observe cases in hospitals, and engage in planned and unplanned customer interactions.
• Create and evaluate prototypes to support concept and model approvals.
• Adhere to safety policies and procedures.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance or reimbursement
• Global well-being program
• Incentive plans, including eligibility for the Medtronic Incentive Plan short-term incentive
• 401(k) plan with 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior