SR. Director or VP of Mfg jobs in United States
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Medical Instrument Development Laboratories, Inc. · 1 day ago

SR. Director or VP of Mfg

Medical Instrument Development Laboratories is a rapidly expanding medical device company dedicated to the research, innovation, design, engineering, and manufacturing of surgical devices. The Senior Director / Vice President of Manufacturing will oversee and optimize all manufacturing functions, ensuring excellence in quality, cost, delivery, and compliance while supporting product development and commercialization.

Health CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote

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

Qualification

Manufacturing leadershipFDA regulationsLean manufacturingSix SigmaProcess validationProduct commercializationSupplier managementCross-functional collaborationMicrosoft OfficeCommunication skills

Required

8 – 15+ years of progressive manufacturing leadership experience, preferably within the medical device industry
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
Bachelor's degree in Operations, Engineering, Manufacturing, or a related field, or equivalent experience required

Preferred

Master's degree preferred

Company

Medical Instrument Development Laboratories, Inc.

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MID Labs was founded by Dr. Carl Wang in 1981 and has been associated with vitreoretinal surgery from its infancy.

H1B Sponsorship

Medical Instrument Development Laboratories, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2020 (1)

Funding

Current Stage
Growth Stage
Total Funding
$51M
2018-10-18Acquired
2014-10-16Series Unknown· $51M

Leadership Team

A
Arlene Alvarez
Director, QA/RA
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C
Carl Wang
Founder
Company data provided by crunchbase