New Product Development Engineer II

The role is for a New Product Introduction (NPI) Engineer responsible for technical support in manufacturing transfer operations, specifically for bioelectronics or complex interventional catheters production.

• Follow company policies and procedures.
• Develop cost-effective manufacturing processes and improve product flow and quality.
• Lead design transfer of new products to production.
• Collaborate with cross-functional teams for design for manufacturability.
• Implement process improvements and cost reduction programs.
• Maintain project schedules and timelines.
• Organize interdepartmental activities to deliver business solutions to customers.

• BS in Industrial/Mechanical Engineering or equivalent.
• 3+ years of experience in medical device Quality, Manufacturing, or Program Management.
• Familiarity with FDA QSR and ISO 13485 regulations.
• Experience in contract manufacturing and lean manufacturing techniques.
• Strong computer skills and knowledge of GMP regulations.
• Excellent communication skills and ability to work in a fast-paced environment.
• Problem-solving skills and ability to work both independently and in a team.