Engineer II
DescriptionEngineer IILocation:
Virginia Beach, VirginiaDepartment:
Product Development & EngineeringJob Type:
Full-TimeLifeNet 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 Engineer II is responsible for the design, development and/or implementation of allograft clinical solutions and manufacturing processes including improvements to existing products and processes.
Drafts and executes performance and qualification test plans in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards in allograft design and development duties.
What you'll do:
Designs and develops new or improved allograft tissue products, equipment and processes.
Serves as the lead engineering resource and/or the project lead on a new product using existing technologies (medium to high complexity) with a cross-functional team.
Can lead multiple line extensions or new products (low complexity) utilizing existing core technologies requiring smaller teams.
Prepares and presents updates to colleagues and management.
This includes responsibility to investigate assigned complaints and errors.
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 LNH's design control process.
Generates complex technical protocols and reports as applies to verification and validation of new products and/or improvement implementations.
Responsible for mentoring peers on new or existing procedures and acts as a subject matter expert (lead to be consulted with on proposed changes, improvements, etc.
) for new and/or existing equipment, processes or products.
Maintains production, design and development records in accordance with LNH Standard Operating Procedures (SOPs).
Supports the engineering needs of other LNH departments as determined appropriate.
What you'll bring (Minimum Requirements):
Bachelor of Science Degree in Engineering required; Master's Degree in Engineering, preferred White Belt Lean Certification from LNH Lean University or similar within 1 year required; Green Belt Lean Certification, preferred 5 years Engineering experience in a medical device development/ manufacturing environment or equipment design required; 6 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 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 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 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.
Recommended Skills Clinical Works Coaching And Mentoring Failure Mode Effects Analysis Leadership Manufacturing Mathematics Estimated Salary: $20 to $28 per hour based on qualifications.
Virginia Beach, VirginiaDepartment:
Product Development & EngineeringJob Type:
Full-TimeLifeNet 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 Engineer II is responsible for the design, development and/or implementation of allograft clinical solutions and manufacturing processes including improvements to existing products and processes.
Drafts and executes performance and qualification test plans in compliance with LifeNet Health (LNH) Quality Systems (QS)/Regulatory Affairs (RA) standards in allograft design and development duties.
What you'll do:
Designs and develops new or improved allograft tissue products, equipment and processes.
Serves as the lead engineering resource and/or the project lead on a new product using existing technologies (medium to high complexity) with a cross-functional team.
Can lead multiple line extensions or new products (low complexity) utilizing existing core technologies requiring smaller teams.
Prepares and presents updates to colleagues and management.
This includes responsibility to investigate assigned complaints and errors.
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 LNH's design control process.
Generates complex technical protocols and reports as applies to verification and validation of new products and/or improvement implementations.
Responsible for mentoring peers on new or existing procedures and acts as a subject matter expert (lead to be consulted with on proposed changes, improvements, etc.
) for new and/or existing equipment, processes or products.
Maintains production, design and development records in accordance with LNH Standard Operating Procedures (SOPs).
Supports the engineering needs of other LNH departments as determined appropriate.
What you'll bring (Minimum Requirements):
Bachelor of Science Degree in Engineering required; Master's Degree in Engineering, preferred White Belt Lean Certification from LNH Lean University or similar within 1 year required; Green Belt Lean Certification, preferred 5 years Engineering experience in a medical device development/ manufacturing environment or equipment design required; 6 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 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 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 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.
Recommended Skills Clinical Works Coaching And Mentoring Failure Mode Effects Analysis Leadership Manufacturing Mathematics Estimated Salary: $20 to $28 per hour based on qualifications.
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