Piper Companies is seeking a Sr. Product Development Engineer for a large clinical development company in King of Prussia, Pennsylvania (PA). The Sr. Product Development Engineer will design & development of medical implant/instruments systems in the orthopedic arena, particularly spinal constructs. Work is expected to encompass both the development of new products and maintenance of existing products.
Responsibilities for the Sr. Product Development Engineer:
- Be the lead engineer in the development of medical devices, including implants and surgical instrumentation.
- Complete all quality system requirements per ISO 13485 and FDA Quality System Regulations (Ex. 21 CFR 820), including documentation and training.
- Develop DHF documents that meet the requirements of the applicable Quality System.
- Utilize 3D CAD and FEA software for CAD models, drawings, and specifications.
- Conduct, support, and record Design Verification and Validation activities (Ex. Mechanical Testing, Cadaver Labs, etc.); and Design Reviews.
- Support and the development of its products, through on-site and off-site meetings, trade shows/society meetings, and educational events. Travel as needed.
- Interact with Faculty Physicians to define clinical needs, generate intellectual property, and gather Design Input for new/improved medical devices.
- Initiate and follow through with the generation of Regulatory Submissions with outside consultants.
- Assist on the generation and evaluation of Intellectual Property with outside counsel.
Requirements for the Sr. Product Development Engineer:
- Solidworks, Creo, 3D Cad drafting expertise. Need someone that can take an idea from a napkin and turn it into a 3D Image.
- Medical device 13485 background - Not just new products but existing product alterations to meet client requests.
- Self-motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
- Excellent communication skills -- verbal and written.
Compensation for the Sr. Product Development Engineer:
- $80,000 - $85,000 based on relevant experience
- Comprehensive Benefits Package