Based in Fremont, California, PrinterPrezz is the first medifacturing™ company in the world, combining polymer and metal 3D printing, nanotechnologies and surgical expertise to design and manufacture next generation medical devices. We help customers at every stage of the product life cycle from early concept development to volume production.
Medical Device Project Manager Position Summary
- Work with company’s sales and manufacturing teams and prospects to manage 3DP medical device development and manufacturing projects from inception through regulatory approval, ensuring a clean handoff to manufacturing.
- Productize and monetize the company’s medical device development know how to maximize customer acquisition and product development revenue potential.
- Lead product commercialization efforts for major third party and OEM implantables, including design and prototyping, V&V and manufacturing and regulatory documentation.
- The scope of opportunities includes 3D printed plastic and metal implantables, primarily Class II, but with a strong focus on volume 3D printed implants and instruments.
- Work collaboratively with Marketing, Operations and Sales to understand customer requirements and production timelines.
- Collaborate with partners, contract manufactures, and specialists to optimize designs for manufacturability and product quality.
- Lead design control activities for new product development (NPI) from initial concept and prototyping through commercialization.
- Perform troubleshooting on products/processes as related to design, material, or process.
- Manage verification and validation activities to ensure product designs meet customer requirements. Establish build qualification metrics and product acceptance criteria.
- Generate documentation relevant to design control and other applicable regulatory requirements.
- Develop and manage medical device product launch plans and schedules and lead cross-functional commercialization teams.
- Communicate effectively with customers and the sales and manufacturing teams, insuring timely and accurate project updates.
- Resolve conflicts and deliver scheduled milestones.
- Ensure compliance with documentation guidelines and hold design reviews in accordance with product development procedures.
- Maintain proper design controls, risk management and design history files.
- Complete engineering deliverables for all FDA filings.
- Lead team in developing, validating, and documenting product, test and process requirements.
- Generate test protocols, reports and supporting documentation for formal design verification.
- B.S. in Mechanical or Biomedical Engineering or other relevant engineering field.
- Minimum 5 years of experience in product development for medical devices, preferably orthopedic implants in an ISO 13485 and 21 CFR Part 820 environment.
- Experience with orthopedic implant design, prototyping and development activities.
- Proficiency maintaining design control activities for new product development from first article of inspection (FAI) through commercialization.
- Experience developing and leading verification and validation activities for customer design projects.
- Knowledge in additive manufacturing (DFAM) and understanding in developing process specifications to control product quality a plus.
- Hands-on design and prototyping skills and proficiency in SolidWorks and ideally FEA.
- Ability to create procedures, work instructions, and forms to ensure compliance with regulatory requirements.
- Demonstrated ability to develop detailed project schedules and manage execution.
- Strong verbal & written communication skills including ability to present technical information before peers, leadership, surgeons, and outside partners
- Experience with scripting and programming for design.
- Ability to create engineering drawings, including assignment of dimensions and tolerances to designs.
- Ability to solve complex problems, deliver on assigned tasks on time and work with minimum guidance and supervision. Knowledge of conventional manufacturing processes and ASTM Standards (complementary to AM processes, such as CNC machining, inspection, coating, plating, infiltrating, painting, injection molding, casting, investment casting, etc.).
Job Type: Full-time