Product Development Engineer II

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 Healths success:

The Product Development Engineer II is responsible for the design, development and/or implementation of allograft clinical solutions including significant improvements for existing products and processes within the manufacturing processes. Drafts and executes verification and validation test plans in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards in allograft design and development duties.

What youll do:

Product Resource: Serves as the lead engineering resource and/or the project lead on a new product using existing technologies with cross-functional teams. May lead multiple line extensions or new products (low complexity) utilizing existing core technologies requiring smaller teams. Prepares and presents updates to colleagues and management.
Technical Consult: Acts as a technical expert (lead to be consulted with on proposed changes, improvements, etc.) for existing equipment, processes or products.
Design Control: Drafts and coordinates the execution of development and test plans, testing protocols of new allograft tissues, new processes and the improvement of existing processes utilizing LNHs design control process. Generates complex technical protocols and reports as applies to verification and validation of new products and/or improvement implementations.
Mentor: Responsible for mentoring peers, newer engineers, and technicians on existing procedures
Support: Supports the engineering needs of other LNH departments as determined appropriate.

What youll bring (Minimum Requirements):

Bachelor's degree in Engineering and five (5) years of engineering experience in a medical device product development or a similarly regulated industry (e.g. aerospace, pharma) OR
A Masters degree or PhD in Engineering and three (3) years of engineering experience in a medical device product development or a similarly regulated industry (e.g. aerospace, pharma)

Preferred Qualifications:

Master's degree or PhD in Engineering
White or Green Belt Lean Certification or similar - Certification from LNH Lean University or similar
Five (5) years of experience in the medical device industry or directly related graduate studies
Two (2) years of experience in medical device product development
Computer Skills: Solidworks, MiniTAB, JMP
Project Management: Microsoft Project proficiency
Critical Thinking: Ability to lead Failure Mode and Effects analysis (FMEA), root cause analysis, and/or complaint investigations
Biomedical Engineering and Technology: Knowledge of the practical application of engineering science and technology to production and development of clinical solutions

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

Computer Skills: Microsoft Outlook, Word, Excel and PowerPoint.
Project Management: Microsoft Project experience; able to manage project activities and meet deadlines as required including the use of appropriate quality and design control tools and methods; able to present project information and data to project team and management.
Critical Thinking: Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems; able to apply Failure mode and effects analysis (FMEA) and root cause analysis techniques.
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.
Team: Ability to work collaboratively in a team environment and coordinate multiple activities with a wide variety of disciplines within the company; open to others ideas; able to lead project teams of technical staff.
Engineering & 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 on recommended path; able to deliver a formal presentation.

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: $87,226 to $116,301 annually

The pay rate for the successful candidate will depend on geographic location and the candidates qualifications and prior relevant experience. The pay range for this position is $87,226 annually (entry-level qualifications) to $116,301 annually (experienced in this role).

* Actual compensation may be higher based on the successful candidates 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.

PI261126896