Sr. Mechanical Engineer

Job Description

Provide technical leadership for sustaining and improving Class II and Class III cardiovascular medical devices, including VADs, blood pumps, and oxygenators. Lead investigations, testing, risk mitigation, manufacturing and supplier support, and cross-functional product lifecycle improvements while ensuring regulatory and quality compliance.

Requirements: A bachelor's degree in mechanical, biomedical, manufacturing, or a related engineering discipline and 15 years of progressively responsible medical-device engineering experience are required. Candidates should bring expertise in mechanical design, GD&T, tolerance analysis, manufacturing, risk management, FDA design controls, and complex investigations; a relevant master's degree and cardiovascular device experience are preferred.

Key Skills: Mechanical Engineering, Medical Device Design, Sustaining Engineering, Root Cause Analysis, FDA Design Controls, 21 CFR Part 820, GD&T, Tolerance Analysis, Risk Management, FMEA, Verification And Validation, Reliability Engineering, Failure Analysis, Manufacturing Processes, Supplier Qualification, Cross-Functional Technical Leadership

Benefits: Medical Insurance, Dental Insurance, Vision Insurance, Critical Illness Insurance, Accident Insurance, Hospital Insurance, 401(k) Retirement Plan, Life Insurance, Short-Term Disability, Long-Term Disability, Health Savings Account, Transportation Benefits, Employee Assistance Program, Paid Time Off, Vacation Leave, Sick Leave