Senior Mechanical Engineer

Senior Level Mechanical Engineer

We are seeking a senior level Mechanical Engineer to provide technical leadership for sustaining and improving complex Class II and Class III medical devices. The role focuses on mechanical and electromechanical design, verification and validation, reliability, failure investigation, and product improvement. This position will lead complex technical investigations and collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, and supplier teams. The engineer will support product safety, reliability, compliance, manufacturing performance, and lifecycle improvement while providing technical guidance to engineering teams.

Key Responsibilities:

• Lead sustaining engineering initiatives involving complex Class II and Class III medical devices.
• Lead technical investigations related to product performance, complaints, CAPAs, nonconformances, and field issues using structured root cause analysis.
• Research, develop, test, and sustain mechanical and electromechanical systems.
• Develop test strategies, test methods, protocols, fixtures, and engineering equipment for verification, reliability testing, and failure analysis.
• Apply analytical, experimental, empirical, and numerical methods to evaluate product performance and investigate failures.
• Analyze complaint, post market, manufacturing, and reliability data to identify trends and improvement opportunities.
• Create and review engineering drawings, specifications, GD&T, tolerance analyses, and engineering stack ups.
• Identify technical risks and develop mitigation strategies using risk management methodologies.
• Evaluate manufacturing processes including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly.
• Support supplier selection, qualification, technical evaluations, regulatory activities, audits, inspections, and technical inquiries.
• Collaborate with cross functional teams and provide technical coaching and mentorship to engineers.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.
• 15 or more years of progressively increasing engineering responsibility supporting Class II or Class III medical devices.
• Experience with product development, sustaining engineering, verification and validation, manufacturing support, and risk management.
• Strong understanding of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.
• Experience leading complex technical investigations and root cause analysis.
• Strong expertise in mechanical design, GD&T, tolerance analysis, materials, manufacturing processes, and assembly methods.
• Experience with FMEA and medical device risk management.
• Demonstrated technical leadership across complex cross functional programs and ability to influence technical decisions without direct authority.
• Strong written, verbal, presentation, and technical communication skills.
• Ability to travel approximately 10 percent including domestic and occasional international travel.

Preferred Qualifications:

• Master's degree in Mechanical Engineering, Biomedical Engineering, or related discipline.
• Experience with ventricular assist devices, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.
• Experience with post market surveillance, complaint investigations, CAPA, reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.
• Experience in medium to high volume medical device manufacturing environments.
• Experience with CAD systems, DOE, SPC, Six Sigma, and project management methodologies.
• Knowledge of ISO 13485, ISO 14971, EU MDR, and other applicable medical device standards.
• Experience working with external manufacturing partners and global suppliers.
• Exposure to electrical systems, software controlled devices, polymers, biomaterials, and biological systems.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - as applicable.