Mechanical Engineer - Implantable Drug Delivery Systems

Role Summary

Mechanical Engineer to drive product design and development for implantable drug delivery systems. Requires extensive experience in medical device design, design for manufacturability (DFM), GD&T, and GMP. Familiarity with regulatory requirements for implantable devices and tolerance-focused engineering.

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 early in the design phase to ensure robust, scalable, and regulatory-compliant implantable products.
• Ensure all designs are fully compliant with relevant GMP, FDA, and ISO requirements specific to long-term implantable medical devices.
• Assign all tolerances and material selections with clear justification tied to the end-use environment (e.g., biocompatibility, sterilizability, in-body durability), and anchored in URS and clinical requirements.
• Collaborate closely with cross-functional stakeholders (R&D, manufacturing, 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 the unique aspects of implantable device safety and performance.
• Support the transition from prototyping to scaled manufacturing, addressing material selection, assembly, and cleaning processes suitable for implantables.
• Document design decisions thoroughly for full regulatory traceability and audit readiness.

Qualifications

• Required: Bachelor‚Äôs degree in Mechanical Engineering (or related biomedical engineering field).
• Required: A minimum of 6 years of medical device experience.
• Required: Product design experience for implantable medical devices.
• Required: Experience with design, development, and manufacturing transfer of implantable drug delivery devices or other active implant systems.
• Required: A proven track record in meeting clinical and regulatory requirements.
• Required: Deep understanding of GMP and regulatory demands of implantable devices (including design history files, design controls, risk management).
• Required: High-level proficiency in design for manufacturability, specifically for products requiring robustness in vivo, sterilization compatibility, and miniaturization.
• Required: Strong command of GD&T for precision assemblies, with hands-on experience assigning and reviewing tolerances.
• Required: High proficiency with solid modeling and drawing software (SolidWorks, AutoCAD, or similar), and engineering documentation in a regulated environment.
• Required: Skillful at translating user needs into clear, actionable URS - including consideration of implant environment, mechanical stresses, and biocompatibility.
• Required: Effective communicator with a collaborative spirit who's also adept at dealing with shifting priorities (flexible).
• Required: The role requires 3 days in the office.
• Required: Legally authorized to work in the US.

Skills

• Design for manufacturability (DFM)
• GD&T (geometric dimensioning and tolerancing)
• Regulatory compliance (GMP, FDA, ISO) for implantables
• Design History File (DHF) and design controls
• Risk management and verification/validation
• Material selection, biocompatibility, sterilization considerations
• Solid modeling and engineering documentation in regulated environments
• URS translation and cross-functional collaboration

Education

• Bachelor‚Äôs degree in Mechanical Engineering or related biomedical engineering field

Additional Requirements

• The role requires 3 days in the office.