SR Director or VP of Manufacturing

Senior Director / VP of Manufacturing

We are a revenue-generating, well-financed, and rapidly expanding medical device company dedicated to the research, innovation, design, engineering, and manufacturing of surgical devices used to prevent blindness caused by disease and traumatic injury. Our team is driven by purpose, quality, and innovation, and we seek leaders who are passionate about making a meaningful impact through operational excellence.

The Senior Director / Vice President of Manufacturing is a senior leadership role primarily responsible for overseeing, optimizing, and scaling all manufacturing-related functions. This role has a strong hands-on focus on manufacturing execution, production planning, sustaining engineering, and supply chain readiness within a regulated medical device environment. The position ensures manufacturing excellence across quality, cost, delivery, and compliance, while partnering with R&D and Quality to support product development, transfer, and commercialization. Success is defined by building scalable manufacturing processes, improving efficiency, and ensuring consistent, compliant production to support business growth.

Key Responsibilities

• Provide executive leadership and direct oversight of all manufacturing operations, including production, assembly, kitting, purchasing, supplier management, and sustaining engineering.
• Develop and execute a manufacturing strategy aligned with company growth, product roadmap, and commercialization timelines.
• Own manufacturing readiness for new product introductions (NPI), including design transfer, process validation, equipment qualification, and scale-up.
• Drive manufacturing efficiency, yield, cost reduction, and capacity planning through Lean manufacturing, Six Sigma, and continuous improvement initiatives.
• Establish and maintain best practices for production planning, inventory management, component sourcing, and supplier performance.
• Oversee sustaining engineering activities, including manufacturing engineering, equipment maintenance and qualification, root cause investigations, and product failure analysis.
• Partner closely with R&D to ensure manufacturability, process robustness, and smooth transition from development to production.
• Collaborate with Quality Assurance to define, implement, and maintain manufacturing and production procedures compliant with FDA, ISO 13485, MDD/MDR, and other applicable international regulations.
• Ensure manufacturing operations consistently meet quality, regulatory, and documentation requirements.
• Lead, mentor, and develop manufacturing managers and staff, fostering accountability, engagement, and a culture of safety, quality, and continuous improvement.
• Establish manufacturing KPIs (e.g., throughput, yield, scrap, on-time delivery, cost) and use data-driven insights to drive performance improvements.
• Manage multiple manufacturing projects and priorities through clear policies, procedures, and systems.
• Serve as the primary manufacturing interface with suppliers, contract manufacturers, auditors, and regulatory agencies, as needed.

Required Skills & Experience

8 15+ years of progressive manufacturing leadership experience, preferably within the medical device industry. Final leveling (Senior Director or Vice President) will be determined based on experience, scope, and organizational needs.

At least 7+ years of progressive responsibility leading manufacturing, production, and sustaining engineering teams in a regulated environment.

Deep working knowledge of FDA, ISO 13485, MDD/MDR, and international manufacturing and quality requirements.

Proven experience leading manufacturing scale-up, process validation, and product commercialization.

Strong background in Lean manufacturing, Six Sigma, and driving measurable improvements in cost, quality, yield, and delivery.

Demonstrated success in manufacturing transfer from R&D to production and supporting ongoing sustaining activities.

Experience managing suppliers, component sourcing, and external manufacturing partners.

Ability to work effectively with cross-functional teams, including R&D, Quality, Regulatory, and Supply Chain, to resolve manufacturing and production challenges.

Excellent verbal, written, and interpersonal communication skills, with the ability to influence across technical and leadership teams.

Advanced proficiency in Microsoft Word, Excel, and PowerPoint.

Other Responsibilities

May require domestic and international (including China) travel.

Education

Bachelor's degree in Operations, Engineering, Manufacturing, or a related field, or equivalent experience required. Master's degree preferred.

Annual Base Salary: $200,000 $290,000 DOE (Depending on Experience)

Location: San Leandro, CA (Onsite, Full-time)