Senior Director​/VP of Manufacturing

POSITION SUMMARY:

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.

• 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.

May require domestic and international (including China) travel.

• 12–15+ 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, PowerPoint and Net Suite.

Bachelor’s degree in Operations, Engineering, Manufacturing, or a related field, or equivalent experience required. Advanced degree desirable.

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

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

Company Website:

Employment Type: Full-time

Medical Instrument Development Laboratories, Inc. (MIDLabs) is an equal opportunity employer. We are committed to fostering an inclusive, diverse, and respectful work environment and do not discriminate based on race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other legally protected characteristic. Applicants from all backgrounds are encouraged to apply.

Note:

This post is for informational purposes only. We are not accepting unsolicited recruiter inquiries at this time.