Senior NPI Manufacturing Engineer – Cardiovascular Devices

North County SD

Join a San Diego-based medical device startup developing breakthrough technologies in the electrophysiology space. The company is led by a seasoned team with strong financial backing and strategic partnerships, creating an exciting opportunity to join at a high-growth stage.

In this role, you’ll be a key player driving continuous improvement, partnering closely with R&D to enhance manufacturability, and supporting transfer activities to their contract manufacturer.

Key Responsibilities:

• Lead process development and improvement initiatives, including validation activities (IQ/OQ/PQ)
• Design and develop tooling and fixtures to optimize production
• Collaborate with R&D to enhance design for manufacturability (DFM)
• Drive cost reduction (COGS) and process efficiency projects
• Support V&V testing, documentation, and regulatory compliance

Qualifications:

• Experience in process development, validation, and manufacturing engineering within a regulated environment
• Proven ability to improve manufacturability and scale processes efficiently
• Hands-on experience with tooling and fixture design
• Strong communication and collaboration skills across R&D and manufacturing teams