Location: Sarasota, FL
Summary of Functions:
Participates in all aspects of design and development of new products and changes to existing products including, but not limited to:
- Generating related design documentation;
- Assisting with inspection, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ) as necessary;
- Performing product testing;
- Assisting with document control as necessary.
This position reports to President Sports Medicine.
Major Duties and Responsibilities/Authority:
- Developing and innovating new Procedure Enabling medical devices including instruments, suture anchor systems, and orthopedic delivery enable devices.
- Generating, reviewing, and/or approving product documentation including, but not limited to, design documentation (e.g. design plan, design inputs, etc.), drawings/prints, inspection procedures, protocols, reports, labeling, risk management documentation (e.g. risk management plan, risk analysis, etc.), deviation requests, and regulatory submissions.
- Supporting industrialization and tech-transfer activities of newly developed products into production at internal and external sites.
- Maintaining Design History File (DHF), Risk Management File, Device Master Record (DMR), and Technical File as necessary.
- Assistance with design related issues (e.g. nonconformances, customer complaints, etc.)
- Project management and training as necessary.
- Ensure safety and quality considerations and requirements are pro-actively addressed and implemented in product production processes.
- Assist in the timely resolution of safety and quality issues raised by customers or staff.
- Support Parcus Medical Quality System and Safety and Health Program by following procedures and advising others, utilizing Quality by Design, Design Control, and Design for Manufacturability best practices to enable smooth transition of products from development to manufacturing.
- Ability to work at a desk.
- The employee might be frequently required to climb stairs, kneel, or crouch, in accordance with job duties.
- Ability to lift up to 30lbs.
Experience and/or Educational Requirements:
- Engineering degree, preferably Mechanical or Biomedical;
- Experience with or ability to learn MS Office, SolidWorks and/or other CAD/CAM packages, and inspection/testing software;
- A minimum of 3+ years designing and developing medical devices with Class I and Class II device experience.
- 5+ years Sports Medicine experience and/or familiarity with FDA QSR’s and ISO 13485 preferred.
Work out of the Sarasota office during the hours of 8:00 AM to 5:00 PM M-F (subject to change).
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.