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.
EDUCATION: Bachelor’s degree in operations, Engineering, Manufacturing, or a related field, or equivalent experience required. Master’s degree preferred.
“Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance”
