Biomedical Product Design Engineer

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 Client's Biomet's mission and grow Client's Biomet's market leadership position.

Principal Duties and Responsibilities:

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 Client's Biomet cross-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 Client's Biomet 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 Client's Biomet procedures and global regulatory requirements

Supports Client's Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

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 Client's Biomet's mission and grow Client's Biomet's market leadership position.

Principal Duties and Responsibilities:

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 Client's Biomet cross-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 Client's Biomet 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 Client's Biomet procedures and global regulatory requirements

Supports Client's Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities