Engineer I, R&D – Medical Device Manufacturing

About the role

The Engineer I, R&D will support medical device manufacturing for existing and new product development. The role involves creating and verifying specifications, designing fixtures and equipment, and ensuring processes meet quality standards.

Key responsibilities

• Support new and existing manufacturing processes, tooling, and fixtures.
• Draft and execute validation of products, equipment, and processes.
• Provide mechanical design concepts using SolidWorks to improve capacity, efficiency, cost, and quality.
• Lead prototype and pilot builds, train operators, and coordinate with production planning.
• Analyze data to improve process robustness and repeatability.
• Develop manufacturing documentation such as MP, routers, BOMs, drawings, and specifications.
• Collaborate with quality teams to establish testing and inspection protocols.

Required profile

• Bachelor of Science in Engineering or related field.
• 0‑2 years of manufacturing process development experience.
• Strong written and verbal communication, organizational skills, and ability to work in a fast‑paced, self‑directed environment.

Required skills

• SolidWorks mechanical design.
• Statistical process analysis techniques (DOE, Cpk).
• Proficiency with MS Word, Excel, Teams, Outlook.
• Technical documentation and CAD modeling.
• Knowledge of Six Sigma or Lean methodologies (advantageous).