PRODUCT DEVELOPMENT ENGINEER OVERVIEW: This position is responsible for the design and development of medical devices, device accessories and quality system requirements for the current product lines in neurological, orthopedic, and plastic / reconstruction surgery areas. This position also involves training technicians, inspectors, engineers, sales representatives, customers, etc., to processes and principles associated with the technology, as well as providing ongoing technical support.
DUTIES OF THE PRODUCT DEVELOPMENT ENGINEER (include but not limited to): - Design and develop medical devices and accessories.
- Complete design drawings in SolidWorks and create feasibility prototypes.
- Use established procedures to improve existing medical devices and accessories.
- Perform statistical analysis of test data and required sample sizes.
- Execute test procedures to verify and validate current product quality and efficacy.
- Perform equipment qualifications (IQ, OQ, PQ), ensure tools are calibrated and complete process validation testing.
- Accomplish new or updated product design verification and validation testing.
- Document all testing results in scientific notebooks and design history files.
- Complete Change Controls (CC) to document procedures and designs.
- Ensure new product development is document through the required design stages.
- Complete design input and design output verifications.
- Continually optimize manufacturing procedures to produce less expensive, higher quality medical devices.
- Design new and / or repair existing tooling and equipment.
- Assist in training PMT personnel with manufacturing and / or inspection processes.
- Develop efficient (i.e. cost, material, time, etc.), user-friendly manufacturing processes.
- Support Regulatory Affairs with FDA 510K submissions and audits of the Quality System.
- Assist with maintenance of required documentation and the Quality System.
- Investigate root causes of product complaints and assist in resolution, documentation, customer responses and corrective actions, (as needed).
- Investigate root cause of non-conformity reports (NCR), product rejects and assist in resolution, documentation, and corrective actions, (as needed).
- Coordinate, manage and assist in corrective and preventative actions.
- Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, MDR, etc.) and associated quality systems described in PMT's documentation.
- Support PMT customers and Sales representatives from a technical standpoint and attend trade shows, as needed.
- Design customer requested non-standard or custom devices.
- Communicate with surgeons and suppliers.
- Design team leader or team member.
- Risk Management team leader or team member.
QUALIFICATIONS: - 4 yr degree in applicable field of study, preferably engineering (ME, ChE, EE, BioMed)
- Minimum 2 years work experience in industry
- Good written and verbal communication skills
- Project management, self-starter and self-organizer. Excellent problem solving and design skills.
- Strong personal computer skills, including experience with SolidWorks, and Microsoft software; Word, Outlook, Excel and etc.
