Senior Engineer

Description

Senior Engineer

Location: Virginia Beach, Virginia

Department: Production & Logistics

Job Type: Full Time

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:

As Senior Engineer, you are responsible for management and/or completion of cross-functional projects including the development, optimization, and introduction of new manufacturing processes and equipment technologies as well as improvements to existing processes. You will draft and execute engineering studies, equipment qualifications, and process validations in compliance with LifeNet Health (LNH) standards to support new product launches and LEAN projects. You will also 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:

• Serve as the lead process engineering resource on new product launches (medium/high complexity) with large cross-functional team. Can lead multiple line extensions (low complexity) utilizing existing core technologies requiring smaller teams.
• Support specification, design/procurement, development, and implementation of new equipment/processes.
• Equipment Qualification (IOQ) to meet LNH standards and regulatory requirements. Create or execute test protocols to challenge equipment performance against intended specifications. Complete protocols and write qualification reports.
• Process Validation to meet LNH standards and regulatory requirements. May include writing protocols, execution of the protocol, and writing the validation report (OQ, PQ/PPQ).
• Generate technical protocols and reports as applies to feasibility studies, process characterization activities and/or improvement implementations.
• Resolve internal and external issues related to manufacturability and performance of processes or equipment including responsibility to investigate assigned complaints and implement corrective actions.
• Prepare and present project updates to colleagues, management, and Sr Leadership.
• Identify risks, issues, and new opportunities and work proactively to implement changes in response to business needs.
• Contribute to project planning and execution to meet schedule and budget requirements.
• Standard Operating Procedures creation, revision and implementation including necessary change order, operator training and verification activities in accordance with LNH Standard Operating Procedures (SOPs).
• Author Quality System documentation to support all the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms.
• Responsible for mentoring peers, junior engineers and techs on new or existing procedures and best practices.
• Act as a subject matter expert (lead to be consulted with on proposed changes, improvements, etc.) for multiple existing equipment, processes or products.
• Support the engineering needs of other LNH departments as determined appropriate.

What you'll bring (Minimum Requirements):

• Bachelor's Degree in Engineering; (Master's Degree in Engineering, preferred)
• White Belt LEAN Certification from LNH University or similar within 1 year; (Green Belt Lean Certification, preferred)
• 8 years Engineering experience in a medical device development/manufacturing environment or equipment design; (9 years directly related medical device engineering experience, preferred)

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

• Proficiency in Microsoft Outlook, Word, Excel, Project Management and Power Point
• Ability 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
• Ability to use 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
• Ability to Identify complex problems and reviews related information to develop and evaluate options and implement solutions
• Ability to use mathematics and engineering principles to solve problems; uses statistics and design of experiment tools to draw conclusions
• 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
• Knowledge of practical application of engineering principles to develop process and product solutions; experienced with a number of processes, systems or products; Subject Matter Expert (SME) in at least one process, product or system; advanced knowledge of design control process and qualification protocols
• Ability 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 won't find another company with a culture as strong as ours.

• 403(b) and Pension Plan
• Medical, dental, and vision coverage
• Corporate sponsored events (Chili Cook-Off, 5K, Celebration of Life Gala, and many more!)
• Work-life balance with generous paid time off
• Tuition reimbursement
• Personal career and skill development opportunities
• Wellness Program
• Food Truck Thursday (at participating locations)
• Employee Assistance Program (EAP)
• Dedicated and passionate co-workers

We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.