Medical Device Validation Engineer Jobs in Virginia

AT LIFENET HEALTH, YOU ARE THE ADVANTAGE

Every day, YOU help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.

Together, we are united by a mission greater than ourselves, a purpose rooted in healing.

ABOUT THIS JOB

Location: Virginia Beach, VA

Department: Production & Logistics

Clinical Status: Non Clinical

HOW YOU’LL MAKE AN IMPACT

The Vice President (VP), Engineering and Production Quality is a key senior leader responsible for shaping and executing engineering and technical strategy for human tissue processing, medical device manufacturing, and cellular therapy product platforms. This role oversees product and process engineering, production quality, internal operation quality objectives, project management, technology transfer, continuous improvement/cost initiatives, and equipment reliability. The VP ensures all engineering and production activities meet defined quality standards, support robust in-process controls, and maintain a state of compliance throughout the manufacturing lifecycle. The VP ensures the organization maintains operational excellence, technical rigor, regulatory compliance, and innovation to support the company’s growth objectives. Additionally, the VP brings deep experience leading engineering in a highly regulated environment (e.g., HCT/Ps, biologics, medical devices, or advanced therapies) and thrives in a fast-paced, mission-driven organization focused on product quality and patient impact.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

WHAT YOU’LL DO

Engineering Leadership & Strategy: 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.

Technical Operations & Execution: 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.

Regulatory & Quality Compliance: 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.

Innovation & Product Support: 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.

Operational Leadership: 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.

WHAT YOU’LL BRING

Minimum Requirements:

• 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)

 Key Knowledge, Skills, & Abilities:

• Computer Skills: 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.
• Communication Skills: 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.
• Regulatory Experience: Expert knowledge of FDA regulations, cGMPs, ISO standards, validation practices, and technical documentation.
• Continuous Improvement: 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.
• Strategic Thinking: Anticipates future operational, technological, and regulatory needs, developing forward-looking strategies that position the organization for scalable growth and long-term competitive advantage.
• People Development: 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.
• Research Problem Solving: 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
• Relationship Management: 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

WHY JOIN LIFENET HEALTH

When you join LifeNet Health, you're not just taking a job, you’re joining a mission-driven community dedicated to making a global impact through regenerative medicine. You’ll be part of a workplace that values authenticity, collaboration, and the drive to make a difference.

We recognize that great work happens when people feel supported. That’s why our total rewards package is designed to help you thrive both professionally and personally.

Here’s how we support YOU:

• 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.

Note: All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law. This job posting does not constitute an employment contract and does not alter the “at-will” nature of employment at LifeNet Health.

COMPENSATION

Salary Range: $201k-$268k Plus Bonus

Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience. 

EQUAL OPPORTUNITY EMPLOYER

LifeNet Health is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

As part of our commitment to safety, we maintain a drug-free workplace and conduct pre-employment substance abuse screening.