bb7 is looking for a Project Engineer to work with one of our top medical device clients. This person will be a critical point of contact for manufacturing method development, test process development, process verification and documentation for manufacturing processes. This position is based in Madison, WI with significant travel to Dublin, Ireland for interaction and cross functional team participation between the device development team and a third-party development partner. This position is responsible for the effective development of scalable manufacturing processes that are consistent with established manufacturing processes and practices, conformance to the device master record, and can deliver resultant manufacturing processes that are compliant with the company quality management systems, FDA part 820 requirements, as well as ISO 13485. Focus of this position will be design for manufacturability and process capability. This role is expected to be a 12 to 18-month assignment with extended (1-2-week duration) assignments in either Dublin or Fermoy, Ireland.
- Responsible for manufacturing methods, tooling, test systems, and documentation ensuring all are in compliance with company quality and regulatory requirements
- Defines and executes test validation and verification plans
- Collaborates with engineering and quality in problem solving with respect to designs that support quality and manufacturability
- Provides inputs on overall manufacturing strategy, tooling and test equipment plans
- Develops work breakdown structure and operational methods sheets (QMS) in conjunction with the sustaining engineering team and manufacturing. Provides training to the manufacturing team as needed.
- Work with engineering and other departments to produce manufacturing cost estimates
- Project lead in conjunction with device development and third party in design for manufacturability
- Liaison between Dublin design team, Device Manufacturing, Manufacturing Engineering, and Sustaining Engineering teams in Madison
- Minimum of an Associate Degree in Electrical or Mechanical Engineering
- 3-10 years of experience in manufacturing technical support; project or team leadership experience
- Relevant experience in new production development and design transfer are highly desirable
- Strong interpersonal skills, good technical communications
- Able to travel to Ireland for 1-2 weeks at a time
bb7 provides a competitive salary, benefits package, and 401(k) options. We offer a culture that values its talented staff members and rewards creativity. We understand that the quality of our staff’s lives is reflected in the quality of their work.
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.