Director, Medical Device Product Development

Director, Medical Device Product Development

Location: Virginia Beach, Virginia (on-site)

Department: Product Development

Job Type: Full-Time

Shift: 8:15 a.m.- 5:00 p.m. (ET), Monday- Friday

Clinical Classification: Clinical

LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.

LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization (“OPO”) and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues, and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process.  LifeNet Health has over 1200 employees and has a growing global presence.

How you will contribute to LifeNet Health’s success:

The Director, Medical Device Product Development will serve as the global functional leader for the Product Development Engineering team for the franchise and will be primarily responsible for the leadership of this team. Reporting to the VP of Product Development, this position is responsible for developing the strategy for the systems, processes, and organizational structure to deliver on the franchise product portfolio pipeline to facilitate strategic growth of the business. The incumbent will directly and indirectly support multi-functional program teams and will partner with the R&D leadership team, affiliated GMs and operational leadership to develop and implement an overarching vision and strategy for product development within the franchise. Manages multiple product development teams to plan and execute projects according to goals, budgets, and timelines to achieve corporate objectives. Guides projects through LifeNet Health’s Design Control Process. Manages Engineers, Technical staff and Project Managers and allocates resources to support corporate priorities.

What you’ll do:

• Provides department leadership to Product Development by leading, guiding and directing employees to be effective team members. Ensures that everyone is equipped with the right skills, tools, and talents necessary for executing their duties. Using the established people processes (performance, development, succession, and career) to ensure that the Product Development team’s level of performance and capabilities meet current and future standards.
• Direct and lead development of new tissue engineered solutions and processes initial design to market release consistent with corporate priorities. This will include strategy for the systems, processes, and organizational structure to deliver on the franchise product portfolio pipeline. This will be performed both through internal development as well as via external partnerships which meets or exceeds established qualify, reliability, delivery and cost targets, facilitating strategic growth of the business.
• Collaborate with senior management and general managers to develop new product pipeline strategy for specific technology focus area including timelines and resource needs.
• Provides technical leadership to support sustaining manufacturing and quality control measures. Leverages technical expertise to provide support and direction for technical staff, including project, study designs, verification and validation planning and adherence to LNH’s quality management system.
• Leads the development and improvement of business process and methodologies driving culture/environment of operational excellence and continuous improvement including cross-functional collaboration activities to drive increased efficiency, innovation and execution on new product initiatives in compliance with appropriate regulatory requirements.
• Collaborates with senior leadership to ensure that the financial, staffing and operational infrastructure are in place to deliver upon agreed strategy. Responsible for staff planning, development and training of staff. Prepares and manages budget for agreed new product / process initiatives.
• Actively seeks new technologies collaboratively with Research and Marketing and maintains a current understanding of pertinent clinical areas. Serves as an interface with physicians and key strategic partners in a technical / clinical capacity.

What you’ll bring (Minimum Requirements):

• Bachelor’s degree in Life Sciences, Biology, Engineering, or a related field from an accredited university.
• Ten (10) years of leading and/ or managing new product development projects: Biologics, biomedical, medical device, or related product development experience.
• Ten (10) years of direct management and leadership of others.

Preferred Experience/Skills/Certifications:

• Master’s degree: Biomedical Engineering, Engineering, Biology, or a related field.
• Fifteen (15) years of leading and/ or managing new product development projects: Biologic, biomedical, medical device or related product development experience.
• Fifteen (15) years of direct management and leadership of others.

These would be nice too (Knowledge Skills and Abilities):

• Strategic Thinking: Strategic planning and interfacing throughout the product lifecycle especially for complex or critical products. Impact of regulatory changes on internal processes and products. Clear, comprehensive understanding of the link between PD and business strategy.
• People Development: Actively engages in talent management practices (selection, promotion, development and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs.
• Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
• Communication Skills: Written, verbal and presentation; ability to engage, inspire and influence people.
• Microsoft Office: Proficient in Microsoft Office and in Project Management Software (e.g. MS Project).
• Organizational Skills: Ability to plan, implement and monitor assignments effectively to meet the needs of the Business.
• Time Management: Ability to use time in an effective and productive manner with ability to work under pressure with tight timelines, make critical decisions and maintain a sense of focus and urgency.

Why work at LifeNet Health?

We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You will not find another company with a culture as strong as ours.

• 403(b) and Profit-Sharing Plan
• Affordable medical, dental, and vision coverage
• Corporate sponsored events for employees
• Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
  • 18 vacation days
  • 9 sick days
  • 7 paid holidays
• Tuition reimbursement
• Personal career, skill, and leadership development opportunities
• Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
• Employee Assistance Program (EAP) for employees and members of their household
• Dedicated and passionate co-worker

Salary: $152,547- $203,396 annually

The pay rate for the successful candidate will depend on geographic location and the candidate’s qualifications and prior relevant experience. The pay range for this position is $152,547 annually (entry-level qualifications) to $203,396 annually (experienced in this role).

* Actual compensation may be higher based on the successful candidate's knowledge and relevant experience.

This position is eligible for an annual bonus once eligibility criteria are met. 

All benefits are subject to eligibility requirements and LifeNet Health reserves the right to modify or change these benefits programs at any time, with or without notice, unless otherwise required by law.  Further, nothing in this posting is intended to alter the “at will” relationship of a successful candidate and this posting does not constitute a specific promise.

LifeNet Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status.  We maintain a drug-free workplace and perform pre-employment substance abuse testing.