Medical Device Design Engineer I

Creative Solutions Services, LLC; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Development Engineer I for a 1 year contract in Warsaw, IN, onsite only. The role focuses on new product design, development, and commercialization of orthopedic devices, with strong emphasis on regulatory alignment and risk management.

You will work under supervision and with senior peers to translate user needs into design inputs, develop production specifications, and participate in verification and validation activities for market-ready products.

Qualifications

• ABet-accredited bachelor of science in engineering (or global equivalent) inMechanical, Biomedical, or related fields.
• Understanding of product design processes and regulatory standards.

Responsibilities

• Stays current with arthroplasty product use, clinical procedures, regulations and standards.
• Identifies user needs via engagement with surgeons and observation of device usage.
• Translates user needs into design inputs to meet market needs and regulatory requirements.
• Creates product designs and documents rationale for design features.
• Prepares invention disclosures and patent-related information.
• Coordinates prototype production, verification, validation and process validation with cross-functional teams.
• Creates production specs accounting for manufacturability and inspection.
• Documents critical-to-quality features and generates inspection plans.
• Evaluates designs to reduce user risk and complies with regulatory requirements.
• Authorizes design control and risk management documents for development.
• Supports design transfers for production of market release quantities.

Education

ABET-accredited BS in engineering

Job description

Creative Solutions Services, LLC is seeking a Development Engineer I for a 1 year contract in Warsaw, IN, onsite only. The role focuses on new product design, development, and commercialization of orthopedic devices, with strong emphasis on regulatory alignment and risk management.

You will work under supervision and with senior peers to translate user needs into design inputs, develop production specifications, and participate in verification and validation activities for market-ready products.