Manufacturing Process Specialist
2 weeks ago
Manufacturing Process Specialist
Location: Virginia Beach, VA (on-site)
Department: Tissue Engineering
Job Type: Full-Time
Shift: 8:15 a.m.- 5:00 p.m. Monday - Friday
Classification: Clinical
LifeNet Health is seeking skilled professionals who are committed to our mission of saving lives, restoring health, and providing hope.
As the largest nonprofit organ procurement organization and tissue processor in the United States, LifeNet Health is at the forefront of innovation in tissue engineering and regenerative medicine. Our aim is to enhance the quality of human life through the provision of organs, tissues, and cells for transplantation, alongside pioneering advancements in bio-implants and regenerative medicine.
Your Role in LifeNet Health's Success:
The Manufacturing Process Specialist plays a crucial role in the design, development, and maintenance of allograft production processes, including enhancements to current products and methodologies. This position involves drafting and executing performance and qualification test plans in accordance with Quality and Regulatory standards for allografts and medical devices.
Key Responsibilities:
- Engineering Resource: Act as the primary engineering resource and/or project lead on initiatives utilizing existing technologies or as an engineering contributor on new technology projects.
- Testing Protocols: Develop and implement testing protocols for allograft tissues, processes, and equipment. Create technical reports for the verification and validation of new products/processes and improvement initiatives.
- Cross-Departmental Support: Provide engineering support to other departments as necessary.
- Mentorship: Guide peers and technicians on established procedures.
- Bachelor's Degree in Engineering with two (2) years of experience in the medical device sector or a similarly regulated field (e.g., Aerospace, Pharmaceutical) OR
- Master's Degree in Engineering with no prior experience in the medical device sector or a similarly regulated field.
- Master's Degree in Engineering.
- Lean Certification (White Belt or Green Belt) from LNH Lean University or equivalent.
- Two (2) years of relevant medical device engineering experience.
- Proficiency in Solidworks, MiniTAB, JMP.
- Knowledge of Biomedical Engineering and Technology, particularly in applying engineering science and technology to clinical solutions.
- Computer Skills: Proficient in Microsoft Outlook, Word, Excel, and PowerPoint.
- Project Management: Ability to oversee project activities and adhere to deadlines using appropriate quality and design control tools.
- Critical Thinking: Employ logic and reasoning to assess the strengths and weaknesses of various solutions and approaches.
- Complex Problem Solving: Identify intricate problems and analyze relevant information to formulate and implement solutions.
- Data Analysis: Utilize mathematical and engineering principles to resolve issues, with a solid understanding of statistics and probability.
- Team Collaboration: Work effectively in a team setting, coordinating multiple activities across diverse disciplines; receptive to others' ideas and capable of leading technical project teams.
- Engineering & Technology: Apply engineering principles to develop process and product solutions; experienced with various processes, systems, or products.
- Communication & Presentation: Effectively convey conclusions and recommendations; capable of presenting complex information to peers.
We are driven by our mission of Saving Lives, Restoring Health, and Giving Hope. Our culture is unique and strong, providing numerous benefits including:
- 403(b) and Profit Sharing Plan
- Comprehensive medical, dental, and vision coverage
- Corporate-sponsored events for employees
- Work-life balance with generous paid time off
- Tuition reimbursement
- Opportunities for personal career, skill, and leadership development
- Wellness Program including gym reimbursement and mental health resources
- Employee Assistance Program (EAP) for employees and their families
- A supportive and dedicated team environment
This position is eligible for an annual bonus based on meeting eligibility criteria.
LifeNet Health is proud to be an EEO/AA employer and maintains a drug-free workplace.
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