Senior Director / Vice President of Manufacturing

Medical Device Manufacturing & Operations Leadership
San Francisco Bay Area | Onsite

Company Overview

A well-funded and rapidly growing medical device company is seeking a Senior Director or Vice President of Manufacturing to lead and scale manufacturing operations in support of commercial growth and product expansion. The organization develops innovative surgical technologies within a highly regulated medical device environment and is focused on operational excellence, quality, and scalable production.

Position Summary

The Senior Director / VP of Manufacturing will provide strategic and hands-on leadership across manufacturing operations, sustaining engineering, production planning, supplier management, and operational scale-up activities.

This individual will play a critical role in driving manufacturing readiness, operational efficiency, product commercialization, and cross-functional collaboration with Engineering, Quality, Regulatory, and Supply Chain teams.

The ideal candidate will bring deep expertise in regulated medical device manufacturing environments and a strong background in scaling operations, continuous improvement, and manufacturing transfer.

Key Responsibilities

Manufacturing Leadership & Operations

• Lead and oversee all manufacturing-related functions, including production, assembly, purchasing, supplier management, and sustaining engineering
• Develop and execute manufacturing strategies aligned with company growth and commercialization objectives
• Drive operational scalability, manufacturing readiness, and production efficiency initiatives
• Establish KPIs and metrics focused on throughput, yield, quality, delivery, and cost optimization
• Manage production planning, inventory strategy, sourcing activities, and supplier performance

New Product Introduction & Commercialization

• Lead manufacturing readiness for new product introductions (NPI)
• Support design transfer, process validation, equipment qualification, and production scale-up efforts
• Partner closely with Engineering teams to improve manufacturability and process robustness
• Support successful transition from development into commercial production

Sustaining Engineering & Continuous Improvement

• Oversee sustaining engineering activities, including manufacturing engineering support, equipment qualification, root cause investigations, and failure analysis
• Drive Lean manufacturing, Six Sigma, and continuous improvement initiatives across operations
• Implement scalable manufacturing systems, processes, and operational best practices

Quality & Regulatory Compliance

• Partner with Quality and Regulatory teams to maintain compliance with FDA, ISO 13485, and applicable international standards
• Ensure manufacturing documentation, procedures, and production activities meet regulatory and quality requirements
• Support audits, supplier quality initiatives, and manufacturing compliance activities as needed

Leadership & Cross-Functional Collaboration

• Build, mentor, and develop high-performing manufacturing and engineering teams
• Foster a culture of accountability, operational excellence, quality, and continuous improvement
• Collaborate cross-functionally with Engineering, Quality, Regulatory, Supply Chain, and executive leadership teams

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Operations, or related field required
• Advanced degree preferred
• 8–15+ years of progressive manufacturing leadership experience within the medical device industry or other regulated environments
• Strong experience leading manufacturing operations, sustaining engineering, and production teams
• Proven success with manufacturing scale-up, commercialization, and process validation
• Deep knowledge of FDA, ISO 13485, and regulated manufacturing environments
• Experience with Lean manufacturing, Six Sigma, and operational improvement methodologies
• Strong supplier management and external manufacturing oversight experience
• Excellent leadership, communication, and cross-functional collaboration skills
• Ability to manage multiple priorities in a fast-paced growth environment

Additional Information

• Domestic and international travel may be required
• Full-time onsite position in the San Francisco Bay Area
• Base Salary: $200,000 – $290,000 DOE