bb7 is looking for a Process Engineer II to work with one of our clients, a leader in the field of regenerative medicine. The Process Engineer II will be responsible for the design, development and/or implementation of allograft clinical solutions and manufacturing processes including improvements to existing products and processes.
- 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 with a medium 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 error.
- 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 internal design control processes.
- 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 internal Standard Operating Procedures (SOPs).
- Supports the engineering needs of other internal departments as determined appropriate.
- Bachelor’s degree in engineering required. Master’s degree in engineering preferred.
- 5+ years of engineering experience in a medical device development/manufacturing environment or equipment design. 6+ years experience directly related to medical device engineering preferred.
- White Belt Lean Certification required (certification from internal Lean University or similar within 1 year). Green Belt Lean Certification preferred.
- Familiar with regulatory standards 1270, 1271, ISO 9001, 13485, and the American Association of Tissue Banks (AATB).
- Computer skills:
- Microsoft Outlook, Word, Excel, PowerPoint and Project. SolidWorks, Minitab, JMP, Visio, SAP.
- Project Management:
- MS 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.
- Able 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 and Technology:
- Knowledge of practical application of engineering principles to develop process and product solutions; experienced with several 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. Biomedical Engineering and Technology knowledge preferred.
- Communications and Presentation:
- Able to communicate conclusions and recommended path; able to present complex information to peers and non-technical leadership; able to describe and convince decision makers on recommended path; able to deliver a formal presentation.
bb7 and its Clients are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, veteran status, marital status, disability, age, membership in an employee organization, or any other classification protected by federal, state, or local law. We participate in E-Verify.