Medical Device 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

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