R&D Engineer-Medical Device

Key Responsibilities:

• Provide R&D support for market-released cardiovascular catheters, ensuring performance and compliance.
• Conduct feasibility studies and develop solutions to enhance product functionality and manufacturability.
• Lead investigations into design changes, CAPAs, NCMRs, and customer complaints, documenting findings.
• Write and submit Engineering Change Orders (ECOs) and maintain rigorous development documentation.
• Collaborate with vendors and cross-functional teams to drive cost-effective design and process improvements.
• Direct support personnel and coordinate project activities to meet timelines.

Qualifications:

• 2 years of medical device R&D experience (cardiovascular devices highly preferred).
• Strong problem-solving skills with a focus on design optimization and manufacturing processes.
• Proficiency in engineering documentation, regulatory standards, and change control (e.g., ECOs).
• Ability to manage multiple priorities in a fast-paced, regulated environment.

Preferred Skills:

• Familiarity with catheter design, biomaterials, or minimally invasive devices.
• Experience with CAPA, NCMR, or complaint investigations.