Product Development Engineer

Roles & Responsibilities

• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices.
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices.
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify, and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies.
• Execute design verification testing to confirm design outputs meet design input requirements.

Experience Required

• 5yr experience regulated devices and Engineering degree or
• 3yr experience regulated devices and Engineering degree with Masters.

Skills & Certifications

• This is a highly collaborative position and requires excellent leadership, verbal, and written communication skills.
• Projects will involve requirements definition, developing test methods, writing test protocols, reports, executing verification testing, solving test or design issues and other types of mechanical engineering activities.
• Applies basic statistical techniques and utilizes design of experiments with moderate guidance.

Eligibilities & qualifications

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering.
• Work experience 5 years or 3 years plus an advanced degree.
• Critical thinking – able to work with moderate guidance in own area of knowledge.
• SolidWorks or equivalent CAD tool.
• Ability to manage multiple projects of varying scopes in parallel.
• Ability to work leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Experience with medical device design control processes and creating and maintaining design control documentation.