R&D Engineer; Product Development - Exp in Medical Device Industry

R&D Engineer (Product Development) - Exp in Medical Device Industry

Position: R&D Engineer – Required experience in Medical Device Industry

Location: San Diego, CA

Duration: 6 Months

Total Hours/week: 40.00

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Industrial

Level of

Experience:

Mid-Level

Employment Type: Contract on W2 (US Citizens, GC Holders, OPT, EAD, CPT)

• Research and Development Engineering is responsible for development and lifecycle management of products through medical device design control processes and good engineering and documentation practices.
• The Infusion Preparation and Delivery (IPD) platform seeks a hardworking and passionate leader to develop and drive technical strategies.
• Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
• Demonstrates working knowledge of product design, development, and design control processes.
• Develops technical plans for design inputs and outputs, conducts analytical and empirical feasibility studies, develops test methods to verify and validate subsystems and systems in order to transfer designs alongside Manufacturing.
• Provides design documentation to support global Regulatory filing strategies.
• Applies basic statistical techniques and utilizes design of experiments with moderate guidance.
• Collaborates within a cross‑functiona team to plan, develop, modify, implement, and support IPD products through rigorous engineering practices.
• Works with moderate guidance to achieve project objectives.
• Flexible work arrangements allow collaboration remotely and onsite.
• R&D engineers lead and support projects as part of a global cross‑functional team.
• Requires excellent leadership, verbal, and written communication skills.
• Projects involve requirements definition, test methods, protocols, reports, verification testing, solving design issues and other mechanical engineering activities.
• Position required to be in the lab and office >80% of the time in San Diego or Brea, CA.

• Drive 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 rigorous engineering practices.
• Engineer robust products through strong 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, transfer designs alongside Manufacturing and Operations, and provide design documentation for global Regulatory filing strategies.
• Execute design verification testing to confirm design outputs meet design inputs.

• 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.
• Solid Works 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.