Senior Process Engineer

Location: Virginia Beach, VA (on-site)

Department: Tissue  Engineering

Job Type: Full-time

Shift: 8:00 a.m.- 4:45 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 Process Engineer supervises engineers and technical staff to support and align with department goals and priorities. Responsible for management and/or completion of cross-functional projects including the design/ development of new allograft manufacturing processes and improvements to existing products and processes. Assists in the development of new products and leads the technology transfer from R&D to production. Drafts and/or provides 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 technology transfer and improvement efforts for new and existing allograft processes and product solutions.

What you’ll do:

• Leadership: Provides oversight to assigned team by supervising, 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 their team's level of performance and capabilities meet current and future standards.
• Process Resource: Serves as the lead engineering resource and/or the project/team lead on multiple concurrent line extensions and/or process changes utilizing existing core technologies requiring cross- functional teams. Serves as the process engineering resource on new product development projects. May lead process development 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 Process Engineering subject matter expert on a key technology (product, process, design, equipment)
• Design Control: Coordinates the planning, development, testing, documentation of verification and validation activities for allograft processing solutions. This includes the drafting and execution of test plans, protocols and reports utilizing LNH's design control process in accordance with LNH Standard Operating Procedures (SOPs).
• 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 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 experience in a medical device or similar regulated industry (e.g. aerospace, pharma)
• Two (2) years of experience in medical device engineering
• Two (2) years of project lead experience or team lead experience (guiding/coaching/mentoring junior engineers)

Preferred Qualifications:

• A Master's degree or PhD in Engineering
• Green Belt Lean certification or similar - certification from LNH Lean University or similar
• Eight (8) years of Engineering experience in a medical device industry
• Eight (8) years of experience in the medical device industry or directly related graduate studies
• Three (3) years of experience in medical device engineering
• Two (2) years of supervisory/ management experience with direct reports
• Computer Skills: Solidworks, MiniTAB, JMP.

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

• 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.
• Project Management: Ability to manage project activities and meet deadlines as required including the use of appropriate quality and design control tools and methods.
• Critical Thinking: Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• 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 and is knowledgeable of statistics and probability.
• Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
• Communication & Presentation Skills: Written, verbal and presentation; ability to engage, inspire, and influence people.
• 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 processes and qualification protocols.
• Computer Skills: Microsoft Outlook, Word, Excel, and PowerPoint.
• 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.
• 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 to $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.