Sustaining Product Engineer – Medical Devices

Medtronic; North Haven (CT); Hybrid; 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 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