Manufacturing Engineer
Talascend is currently seeking a Manufacturing Engineer with our client in Madison, Wisconsin.
SUMMARY:
The Manufacturing Engineer provides guidance and support of manufacturing methods/processes, tooling, equipment, test systems, and documentation to ensure effective medical device manufacturing and to promote continuous improvement.
RESPONSIBILITIES
- Support all manufacturing methods, tooling, preventive maintenance, equipment calibration, test systems, and documentation ensuring compliance with company quality system and regulatory requirements.
- Develop and revise Standard Operating Procedures (SOP), Work Instructions (WI), Device History Records, Validation Master Plans, Process Flow Diagrams or other quality documentation, as necessary, to support production processes.
- Effectively support production associates with medical device manufacturing day-to-day challenges.
- Work closely with Production Associates to improve production processes, improve first pass yield, and design for manufacturability in a timely manner.
- Train Production Associates on new and/or revised production processes, equipment, and documentation.
- Key member of Material Review Board to collaborate and troubleshoots devices and/or components rejected by Manufacturing and Regional Service Centers; documents findings, compiles associated data and metrics, feeds findings into product continuous improvement cycle as appropriate.
- Define and execute verification and validation plans.
- Manufacturing process subject matter expert for medical device Manufacturing Team, Materials Team, Global Device Engineering, QA, and Service Operations.
- Collaborate with engineering and quality in problem solving activities applying statistical techniques/analysis where applicable.
- Provides inputs on overall manufacturing strategy, capital equipment plan, and facilities maintenance program.
- Work with engineering and other departments to produce manufacturing cost estimates for new products.
- Work with device manufacturing team, materials team, R&D, QA, and Technical Operations management to effectively troubleshoot equipment and process issues.
- Serve as engineering resource for material review board, supplier selection team and supplier development team.
- AS in Electrical or Mechanical engineering. A combination of experience, education and training may suffice in lieu of formal education.
- Previous experience as a Manufacturing Engineer or Engineering Technician is preferred.
- Previous experience with manufacturing technical support; project or team leadership experience, preferably in a medical device manufacturing environment is preferred.
- Strong interpersonal skills, good technical communications.
- Excellent time management/organizational skills and ability to work independently.
- Experience with SAP and LabView software is a plus.
- Experience with Lean Six Sigma methodologies and Green Belt Certification preferred.
- Proven ability to manage competing demands in a fast-paced and dynamic work environment.
- Ability to communicate effectively with other departments internal and external.
- Ability to work scheduled/expanded shifts, holidays and/or off-shift duties, as necessary.
We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.