Our client is a global leader in musculoskeletal healthcare. They design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products. Their products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Alongside some of the world's top healthcare professionals, they help deliver new possibilities to patients. You have a key support role with responsibility for new product design, development, and commercialization; and/or to maintain in the market innovative medical device products in order to further company's mission and grow company's market leadership position.

Principal Duties and Responsibilities:

With oversight from supervisor and mentorship by senior peers: Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features Prepares and reviews information for invention disclosures and patents Initiates, provides instruction for and coordinates with support from company across-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with company procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations) Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with company procedures and global regulatory requirements Supports company Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Education:

Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.

Pay:

$42.00 - $47.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Work Location:

In person