Senior NPI Engineer — Medical Device Launch Lead

Viant Medical Inc.; Fremont (CA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Viant Medical, a leader in medical device design and manufacturing, seeks a Senior NPI Engineer to drive the transition of new devices from development into manufacturing with emphasis on quality, regulatory compliance, and producibility. You will partner with R&D, Manufacturing, QA, Regulatory Affairs, Supply Chain and Operations to meet timelines and budgets.

Responsibilities include leading design transfers, establishing process validations, and implementing cost-effective processes while

Qualifikationen

• BS in Industrial / Mechanical Engineering or equivalent.
• 5+ years in medical device quality, development, manufacturing and/or program management.
• Familiarity with FDA QSR and ISO 13485 medical device regulations.
• Lean and Six Sigma methodologies knowledge.
• Experience transferring products between domestic and international sites.
• Knowledge of GMP, 21 CFR 820 and ISO 13485.
• Strong problem-solving and communication skills.

Aufgaben

• Lead new product introductions from design transfer through commercial manufacturing.
• Develop and execute manufacturing readiness plans for new product launches.
• Implement robust manufacturing processes improving flow, quality and safety.
• Lead equipment development and implementation.
• Create manufacturing documentation (BOMs, DMRs, WIs, process flow diagrams).
• Perform root cause investigations and containment measures.
• Coordinate with R&D, Manufacturing, QA, Regulatory and Supply Chain.

Kenntnisse

NPI

Medical devices

Problem solving

Lean manufacturing

Six Sigma

Quality systems

Cross-functional collaboration

English proficiency

Ausbildung

BS in Industrial/Mechanical Engineering

Bachelor’s in engineering or equivalent

Tools

MS Office

ERP

Document Control systems

Jobbeschreibung

Viant Medical, a leader in medical device design and manufacturing, seeks a Senior NPI Engineer to drive the transition of new devices from development into manufacturing with emphasis on quality, regulatory compliance, and producibility. You will partner with R&D, Manufacturing, QA, Regulatory Affairs, Supply Chain and Operations to meet timelines and budgets.

Responsibilities include leading design transfers, establishing process validations, and implementing cost-effective processes while