This position is responsible for the design and development of orthopedic medical devices, device accessories and processes that compliment our current product line.
COMPETENCIES & RESPONSIBILITIES (included but not limited to):
- Design and develop medical devices and accessories.
- Organize projects and maintain Design History Files (DHF)
- Write and Submit 510(k)s to the FDA
- Use established procedures to improve existing medical devices and accessories.
- Continually optimize manufacturing procedures to produce less expensive, higher quality medical devices.
- Perform test procedures to verify and validate product quality and efficacy.
- Document all developments in scientific notebooks
- Complete Document Change Orders (DCO) document and control processes and procedures.
- Assist in the completion of new and existing product design validations.
- Complete design drawings in Solidworks or similar drafting program and create prototypes to progress the development through its design stages.
- Assist in training personnel to processes associated with design and development of medical devices and accessories.
- Develop efficient (i.e. cost, material, time, etc.), user-friendly manufacturing processes.
- Assist in the resolution, documentation, customer responses of product complaints.
- Coordinate and assist in corrective and preventative action activities and solutions
- Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems.
- Communicate with strategic vendors and suppliers.
- 4yr degree in applicable field of study, preferably engineering (ME, BioMedE)
- 3+ years experience in medical device industry
- Strong understanding of design controls
- Understanding of quality and regulatory requirements for Class 1 and Class 2 devices
- Good written and verbal communication skills
- Project management, self-starter and self-organizer.
- Excellent problem Solver