Mechanical Engineer

We are seeking a detail-oriented Mechanical Engineer to drive product design and development and commercialization for implantable drug delivery systems. The ideal candidate will have extensive experience in medical device design, design for manufacturability (DFM), process development and scale-up, and a solid grounding in Good Manufacturing Practice (GMP) and regulatory requirements. Familiarity with unique challenges and regulatory requirements for implantable devices, and a strong orientation toward application-specific tolerances is desired.

Key Responsibilities

• Drive the mechanical design of implantable drug delivery systems, from conceptualization through commercialization, with a focus on meeting demanding implantable device standards.
• Apply design for manufacturability principles to ensure robust, scalable, and regulatory-compliant implantable products.
• Ensure designs and processes are fully compliant with relevant GMP, FDA, and ISO requirements specific to long-term implantable medical devices.
• Specify attributes, tolerances, and material requirements with clear justification tied to the end-use environment (e.g., biocompatibility, sterilizability, in-body durability, etc.), and anchored in URS and clinical requirements.
• Develop assembly, processing, and testing techniques, identifying and controlling critical process parameters to assure robust repeatable processes that meet GMP compliance standards.
• Collaborate closely with cross-functional stakeholders (R&D, manufacturing, supply management, regulatory, clinical) to capture and implement requirements unique to implantation, such as long-term reliability and risk management.
• Participate actively in design reviews, Design History File (DHF) creation, risk analyses, and verification/validation activities, with emphasis on documenting design controls for regulatory traceability and audit readiness.
• Support the transition from prototyping to scaled manufacturing, addressing material selection, assembly, and cleaning processes, and sterilization suitable for implantable products.
• Interact with and manage external venders to source component parts and design/fabricate process equipment.

Requirements

• Bachelor’s degree in Mechanical Engineering (or related biomedical engineering field)
• A minimum of 10 years of medical device experience.
• Experience with design, development, and manufacturing of implantable drug delivery devices or other active implant systems.
• Experience in clinical and regulatory requirements and regulatory interactions as they apply to development and commercial settings.
• Deep understanding of GMP and regulatory demands of implantable devices (including design history files, design controls, risk management).
• Proficiency in design for manufacturability, specifically for products requiring robustness in vivo, sterilization compatibility, and miniaturization.
• Strong hands-on experience assigning and reviewing specifications and tolerances including GD&T for precision assemblies
• Proficiency with solid modeling and drawing software (SolidWorks, AutoCAD, or similar), and engineering documentation in a regulated environment.
• Experience in medical device design control methods and documentation for compliance with FDA and ISO requirements
• Effective communicator with a collaborative spirit who's also adept at dealing with shifting priorities (flexible).
• The role requires 3 days minimum in the office.

Salary range: $140-$180K

Final compensation will be determined based on job‑related factors such as experience, education, and training.

Benefits

• Medical
• Dental and Vision
• Flexible Spending Account (FSA)
• 401K with Company Safe Harbor Match: 100% /up to 4%
• Life Insurance
• Long Term Disability
• Home Office Stipend
• Commuter benefits