Senior NPI Engineer - Medical Device Launch Leader

Viant Medical Inc.; Fremont (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Viant Medical is seeking a Senior NPI Engineer in Fremont, CA to lead the transition of new medical devices from product development to manufacturing. You will collaborate with R&D, Manufacturing, Quality, Regulatory, and Supply Chain to ensure quality, regulatory compliance, and readiness for production.

The role requires strong knowledge of GMP, ISO 13485, and FDA processes, plus hands-on leadership during pilots and scale-up, with emphasis on DFM/ DFA improvements and ECO management.

Qualifications

• BS in Industrial/Mechanical Engineering or equivalent.
• 5+ years in medical device quality, development, manufacturing, or program management.
• Experience transferring designs for neurovascular, cardiovascular, catheter-based, bioelectronics or minimally invasive devices.
• Knowledge of Lean Manufacturing and Six Sigma.
• Familiarity with FDA QSR and ISO 13485.
• Fluent English with strong communication.
• Experience in contract manufacturing or manufacturing environment.
• Knowledge of GMP, 21 CFR 820 and ISO 13485.

Responsibilities

• Lead new product introductions from design transfer to commercial manufacturing.
• Develop and execute manufacturing readiness plans for new product launches.
• Establish assembly time, yield targets, training needs, and quality control.
• Lead manufacturing equipment development and implementation.
• Coordinate with R&D, Quality, Regulatory, Supply Chain, and Operations.
• Maintain manufacturing documentation: BOM, DMR, WIs, Process Flows.
• Mentor junior engineers and provide technical guidance during launches.

Skills

5+ years medical device experience

Fluent English

Problem solving & critical thinking

Cross-functional collaboration

Teamwork

Education

BS in Industrial / Mechanical Engineering

Bachelor’s degree in engineering or equivalent experience

Tools

Automation equipment development

Job description

Viant Medical is seeking a Senior NPI Engineer in Fremont, CA to lead the transition of new medical devices from product development to manufacturing. You will collaborate with R&D, Manufacturing, Quality, Regulatory, and Supply Chain to ensure quality, regulatory compliance, and readiness for production.

The role requires strong knowledge of GMP, ISO 13485, and FDA processes, plus hands-on leadership during pilots and scale-up, with emphasis on DFM/ DFA improvements and ECO management.