Senior Mechanical Engineer

Job Summary:
The Senior Mechanical Engineer will lead the design and development of next-generation active implantable medical devices (AIMDS). This role involves architecting complex mechanical systems that interact with electrical systems and components while ensuring compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate in a cross-functional team to translate clinical needs into manufacturable, high-performance products.

Responsibilities:

• Lead the design, development, prototyping, and testing of mechanical systems and components for implantable devices, including miniaturized electronics housing, hermetic enclosures, biocompatible materials, and implantable leads for signal and power delivery.
• Design mechanical delivery systems and active implantable, considering implantable constraints such as miniaturization, biocompatibility, hermeticity, and long-term reliability.
• Perform CAD modeling, tolerance analysis, and oversee manufacturing processes for precision components, including lead routing and strain relief design.
• Conduct risk analyses (e.g., dFMEA), root cause investigations, and reliability testing to ensure device safety and efficacy.
• Collaborate with cross-functional teams (electrical, firmware, systems, clinical, and quality engineering) to integrate mechanical subsystems and support closed-loop therapies.
• Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, and IEC 60601 series.
• Mentor and provide technical guidance to junior mechanical engineers; lead design reviews and contribute to strategic technology roadmaps.
• Support sustaining engineering for existing products, including troubleshooting, design improvements, and regulatory submissions.
• Stay current with advancements in implantable mechanical design, such as novel biocompatible materials, hermetic sealing technologies, and miniaturization techniques.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 7+ years of experience in mechanical design for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class III devices).
• Expertise in precision mechanical design, biocompatible materials, hermetic enclosures, miniaturization, and implantable lead design.
• Proven track record in medical device development, including full product lifecycle from concept to commercialization.
• Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management.
• Ability to travel up to 15%.

Preferred Qualifications:

• Master’s in Mechanical Engineering or related field. Experience with neuromodulation or cardiac rhythm management.
• Familiarity with advanced manufacturing techniques, hermetic sealing, fatigue analysis, and lead insulation and connector technologies.
• Experience leading technical teams, design reviews, FMEA sessions, or regulatory audits.
• Proficiency in tools such as SolidWorks, ANSYS, or similar for CAD and simulation.