Mechanical Engineer - Implantable Drug Delivery Systems

Company: Vivani

Job Overview

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

Come Join Us!

You'll be part of a talented and dedicated team of engineers, scientists, and other professionals at Vivani Medical, an emerging biopharmaceutical company developing a pipeline of miniature, long-term drug implants with its proprietary NanoPortal platform technology for obesity/weight management and other chronic diseases.

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 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.

Requirements

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

Salary

Salary range: $140-$175K

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