Manufacturing Engineer # JN -032021-61203
Title: Manufacturing Engineer
Location: Westford, MA
Duration: 12 months contract
- Line engineer on the floor working with operations to make sure production is running smoothly, will report any issues and work to fix any quality issues (root cause analysis)
- Will troubleshoot and repair any equipment issues
- Producing Catheters 30-50 units / month
- Time Shift: 7am-3:30pm M-F
- Bachelor’s degree engineering required, Min 2 yrs experience
- Top skills: quality systems, engineering degree, process development/test method validation, Med Device experience or a regulated product with working with Quality Systems is required
- Electronics background strongly preferred (devices are a mix of fiber optics, electronic, mechanical - experience with any of these is helpful)
- production line experience preferred since will working with operations
- Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality
- Evaluation of production equipment
- Production support and process validation (IQ, OQ, PPQ)
- Work with Quality counterpart to address manufacturing nonconformances and customer complaints
- Troubleshoot manufacturing process and equipment
- Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve process and first pass yield
- Understand manufacturing and problem solving concepts like Value Stream mapping, 5S, A3 and DAMIC to improve quality, labor efficiency, and throughput.
- Protocol and report writing
- Generate and modify manufacturing process documentation
- Work with cross functional teams as required
- Develop and implement process improvements
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Bachelors Degree (Mechanical, Industrial, or Manufacturing Engineering preferred) IS REQUIRED.
- 2-5 years of manufacturing engineering experience required. 2+ years experience is preferred.
- Previous medical device experience preferred.
- Experience with electronics and electrical components preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels across different shifts in the organization.
- Be able to work independently without supervision, multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.