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 the Director of Manufacturing.
Major Duties and Responsibilities/Authority:
- 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.
- 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
- 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;
- Medical experience and/or familiarity with FDA QSR’s and ISO 13485 is desirable.
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.