Development Engineer I

Aequor; Warsaw (IN); On-site; USD 90,000 - 135,000; Full time

Job summary

Aequor is seeking a Principal Engineer for medical device design to advance new product development and market-ready products. You will work under supervision and with senior peers to ensure compliance with global regulatory standards and robust product design rationale.

Responsibilities include translating user needs into design inputs, supporting prototype development, verification and validation activities, and collaborating with quality, sourcing, and manufacturing teams for market release

Qualifications

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical, Biomedical, or related fields.
• Strong ability to translate user needs into design inputs and measurable requirements.
• Experience with design verification, design validation, and process validation.
• Familiarity with invention disclosures and patents is a plus.

Responsibilities

• Stays current with arthroplasty product use, procedures, and related regulations.
• Identifies user needs through engagement with product users (e.g., Orthopedic Surgeons).
• Translates user needs into design inputs and documents design rationale.
• Coordinates with cross-functional teams for prototypes, V&V, and design transfer.

Skills

Product design

Regulatory compliance

Education

Minimum B.S. degree in ABET accredited engineering program

Job description

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 our client's mission and grow our client'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 Client 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 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 procedures and global regulatory requirements
• Supports Client Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Skills

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 our client's mission and grow our client'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 Client 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 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 procedures and global regulatory requirements
• Supports Client 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.