Company: Parcus Medical
Posted on: April 11, 2021
Summary of Functions:
Participates in all aspects of design and development of new
products and changes to existing products including, but not
- 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
- 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
- Supporting industrialization and tech-transfer activities of
newly developed products into production at internal and external
- 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
- 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
- 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 prefererd.
Work out of the Sarasota office during the hours of 8:00 AM to 5:00
PM M-F (subject to change).
Keywords: Parcus Medical, Sarasota , Senior Engineer, Engineering , Sarasota, Florida
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