VP Engineering & Production Quality jobs in United States
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LifeNet Health · 16 hours ago

VP Engineering & Production Quality

LifeNet Health is dedicated to saving lives and restoring health through innovation and collaboration. The Vice President of Engineering and Production Quality will lead engineering strategy and ensure compliance in human tissue processing and medical device manufacturing, while fostering operational excellence and innovation.

CharityHealth CareMedicalMedical DeviceNon Profit
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H1B Sponsor Likelynote

Responsibilities

Develops and executes the multi-year engineering strategy supporting growth, capacity expansion, automation, and modernization across all product lines
Provides senior leadership to engineering, process development, maintenance, capital projects, validation, and facilities teams
Partners with executive leadership to align engineering priorities with corporate strategy, operational goals, and regulatory expectations
Leads engineering activities for human tissue processing, medical device manufacturing, and cellular therapy operational platforms, ensuring robust process performance, scalability, and compliance
Oversees execution of major capital projects, including facility expansions, cleanroom upgrades, aseptic processing enhancements, and new technology installations
Ensures equipment reliability programs meet uptime, utilization, and performance metrics
Drives continuous improvement initiatives leveraging Lean, Six Sigma, and advanced manufacturing principles
Ensures all engineering programs, processes, and equipment meet applicable regulatory and industry standards (FDA 21 CFR 1271, 820, 210/211, AATB, ISO 13485, cGMPs for ATMPs, etc.)
Oversees validation, qualification, and change control activities in alignment with Quality systems
Partners closely with Quality and Regulatory Affairs to prepare for inspections, submissions, and external audits
Champions engineering innovation to enhance product quality, safety, and manufacturability across biological tissues, medical devices, and cell therapy products
Supports R&D and Process Development teams with technology transfer, scale-up, and commercialization of new products and processes
Introduces digital technologies, automation, and data-driven tools to optimize operations and improve process robustness
Builds and develops a high-performing engineering organization with strong technical depth and leadership capability
Strengthens cross-functional collaboration with Operations, Quality, Supply Chain, R&D, and Program Management
Develops and manages departmental budgets, ensuring resource optimization and effective cost control

Qualification

Engineering LeadershipRegulatory ComplianceContinuous ImprovementTechnical OperationsData AnalyticsLean Six SigmaStrategic ThinkingPeople DevelopmentResearch Problem SolvingRelationship ManagementCommunication Skills

Required

Bachelor's Degree in Engineering (Mechanical, Biomedical, Chemical, Electrical, or related discipline)
Fifteen (15) years experience Operations/ Production/ Manufacturing experience in Life Sciences, Tissue Banking, Medical Device, Pharmaceuticals or related industry (Preferred 20 years)
Twelve (12) years' experience of managing direct reports (Preferred 15 years)
Proficient with engineering and operations systems and data analytics tools; able to leverage digital platforms to drive efficiency and decision-making
Strong ability to interpret and utilize digital dashboards, automation interfaces, and technical software to support process control and continuous improvement
Communicates complex technical concepts clearly and effectively to both technical and non-technical audiences, including executive leadership and regulatory agencies
Skilled in high-impact written and verbal communication, including presentations, technical reports, and cross-functional alignment
Expert knowledge of FDA regulations, cGMPs, ISO standards, validation practices, and technical documentation
Demonstrates long-term, strategic thinking with the ability to translate vision into actionable engineering and operational roadmaps
Leads continuous improvement initiatives using Lean, Six Sigma, and data-driven methodologies to enhance quality, reliability, and throughput
Anticipates future operational, technological, and regulatory needs, developing forward-looking strategies that position the organization for scalable growth and long-term competitive advantage
Committed to building high-performing teams through coaching, mentoring, and structured development plans that elevate technical capability and leadership strength
Creates a culture of accountability, empowerment, and collaboration while fostering growth in staff at all levels
Applies strong analytical skills and scientific reasoning to troubleshoot complex engineering, process, or product-related challenges
Utilizes structured problem-solving tools (DMAIC, 8D, root cause analysis) to identify root causes and implement robust, sustainable solutions
Builds and maintains strong partnerships across Operations, Quality, R&D, Supply Chain, and external partners to accelerate execution and maintain alignment
Influences and negotiates effectively with stakeholders at all levels to drive consensus, resolve conflicts, and achieve strategic objectives

Preferred

Preferred 20 years of experience in Operations/ Production/ Manufacturing experience in Life Sciences, Tissue Banking, Medical Device, Pharmaceuticals or related industry
Preferred 15 years of experience managing direct reports

Benefits

Affordable Medical, Dental, and Vision Coverage- Comprehensive care that won’t break the bank.
Profit Sharing Plan- Share in the success you help create.
403(b) Retirement Plan- Invest in your future with confidence.
Paid Parental Leave- 6 weeks to bond with your newest family member.
Corporate Sponsored Events- Celebrate milestones and build connections.
Generous Paid Time Off- Because balance matters: 18 vacation days (based on position, tenure, and state laws)
9 sick days (subject to local and state regulations)
9 holidays (7 standard + 2 floating)
Flexible Work Program- For approved roles, how and where you perform best.
Tuition reimbursement- We invest in your growth and education.
Career & Leadership Development- Expand your impact and potential.
Wellness Program- Prioritize your health with holistic resources.
Employee Assistance Program (EAP)- Support for you and your household.
Incredible teammates- Collaborate with passionate, dedicated professionals.

Company

LifeNet Health

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LifeNet Health is a charitable organization in the field of regenerative medicine.

H1B Sponsorship

LifeNet Health 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
2023 (1)
2022 (3)
2021 (3)
2020 (1)

Funding

Current Stage
Late Stage

Leadership Team

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Phil Jones
Chief Financial Officer
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Company data provided by crunchbase