Product Development Engineer

Accede Solutions Inc (accedesolution.com); Warsaw (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Accede Solutions Inc is seeking a key support role focused on new product design, development, and commercialization of innovative medical devices. The role emphasizes understanding arthroplasty devices, translating user needs into design inputs, and ensuring compliance with global regulatory standards.

Responsibilities include prototyping, design transfer, verification/validation, and contributing to patent disclosures, with close collaboration across manufacturing, quality, and regulatory

Qualifications

• Bachelor of Science in an ABET-accredited program in Mechanical, Biomedical, Bioengineering or related field.
• Experience translating user needs into design inputs and documenting design rationale.
• Familiarity with design control, risk management, verification, validation and process validation.
• Ability to collaborate with cross-functional teams and contribute to invention disclosures/patents.

Responsibilities

• Stays current with arthroplasty devices and relevant regulations and standards.
• Translates user needs into design inputs and documentation.
• Creates product designs addressing user needs with rationale and manufacturability considerations.
• Prepares invention disclosures and patents as needed; supports IP activities.
• Coordinates prototyping, verification, validation, and process validation with cross-functional teams.

Skills

Product design

Regulatory compliance

Risk management

Design for manufacturability

Design control documentation

Education

ABET accredited B.S. degree in Mechanical Engineering or related

Biomedical/Bioengineering degree

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 Client’s mission and grow 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’s 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 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 procedures and global regulatory requirements
• Supports Client’s 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 Client’s mission and grow Client’s market leadership position.

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.