Senior Technical Product Development Engineer

Senior Technical Product Development Engineer

Location: Virginia Beach, VA (On-site)

Department: Product Development & Engineering

Job Type: Full-time

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

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 Senior Technical Product Development Engineer is responsible for management and/or completion of cross-functional projects including the design/ development of new allograft solutions and allograft processes including improvements to existing products and processes. Draft and/or provide guidance to the drafting and execution of verification and validation test plans in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards in allograft design and development duties. Serve as a technical Subject Matter Expert (SME) on development and improvement efforts for new and existing allograft processes and product solutions.

What you’ll do:

• Product Resource: Serves as the lead engineering resource and/or the project/team lead on multiple concurrent line extensions and/or new products utilizing existing core technologies requiring cross functional teams. May leads project(s) implementing new technology (high complexity) with a large cross-functional team. Prepares and presents updates to colleagues and management.
• Expertise: Serves as the primary Product Development SME on a key technology (product/ process/ equipment).
• Design Control: Coordinates the planning, development, testing, documentation of verification and validation activities including implementation of new and/or improved allograft solutions. This includes drafting and/or guiding the drafting and execution of test plans, protocols and reports utilizing LNH’s design control process in accordance with LNH Standard Operating Procedures (SOPs).
• Team Development: Responsible for guiding/coaching/mentoring junior engineers on new or existing procedures.
• Support: Supports the engineering needs of other LNH departments as determined appropriate.

What you’ll bring (Minimum Requirements):

• A Bachelor's degree in Engineering and eight (8) years of engineering experience in a medical device or similar regulated industry (e.g. aerospace, pharma) OR a Master’s degree or PhD in Engineering and six (6) years of engineering experience in a medical device or similar regulated industry (e.g. aerospace, pharma).
• Two (2) years of experience in medical device product development.

Preferred Qualifications:

• Master's degree or PhD in Engineering
• White or Green Belt Lean Certification or similar - Certification from LNH Lean University or similar
• Eight (8) years of engineering experience in the medical device industry and eight (8) years of experience in medical device industry or directly related graduate studies.
• Three (3) years of experience in medical device product development.
• Solidworks, MiniTAB, JMP
• Project Management Software: Microsoft Project / Workfront
• Biomedical Engineering and Technology: Knowledge of the practical application of engineering science and technology to production and development of clinical solutions; cross-functional knowledge in manufacturing, research, and/or quality.
• Regulatory Knowledge: Working knowledge of external standards and the application of those to new products/ processes.

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

• Computer skills: Microsoft Outlook, Word, Excel and PowerPoint.
• Project Management: Able to manage project activities and meet deadlines as required including use of appropriate quality and design control tools and methods; able to present project information and data to project team, management and above.
• Critical Thinking: Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems; able to lead Failure Mode and Effects analysis (FMEA), root cause analysis, and/or complaint investigations.
• Complex Problem Solving: Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
• Data Analysis: Uses mathematics and engineering principles to solve problems; uses statistics and design of experiment tools to draw conclusions.
• Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
• Engineering and Technology: Knowledge of practical application of engineering principles to develop process and product solutions; experienced with a number of processes, systems or products; advanced knowledge of design control process and qualification protocols.
• Communication & Presentation: Able to communicate conclusions and recommended path; able to present complex information to peers and nontechnical leadership; able to describe and convince decision makers and senior leadership on recommended path.
• 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.
• Regulatory Knowledge: Working knowledge of design control processes and validation best practices.
• Analytical Thinking: Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends.

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-workers

Salary: $100,306 - $133,741 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 $100,306 annually (entry-level qualifications) to $133,741 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.