Senior Manufacturing Engineer
Steris
- Sharon, PA
- Permanent
- Full-time
- Provide general oversight and monitoring of machinery - including project coordination for maintenance, upgrades, and repair when needed.
- Help with troubleshooting of problems within the manufacturing process
- Identify and implement GMP (good manufacturing practices) that apply to specific production area(s).
- Lead/Own CAPA (corrective and preventative actions) to resolve production and customer issues using root cause analysis and then follow through with implementation of corrective action.
- Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished.
- Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g., qualifications, risk assessments, and work instructions).
- Provide hands-on trouble shooting to both manufacturing equipment and manufacturing processes.
- Provide operations department with effective technical support to meet manufacturing quality and quantity objectives.
- Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics.
- Own and execute cost down initiatives on manufacturing lines.
- Initiate and lead lean transformations on manufacturing lines as well as within supporting areas.
- Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes, including troubleshooting of manufacturing issues when they occur.
- Assess and monitor manufacturing capacity capabilities and reconcile with demand. Propose capacity improvement recommendations accordingly.
- Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements.
- Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment.
- Work with product development engineering to drive back lessons learned as new products are being developed.
- Evaluate and provide input to product development teams to help ensure the introduction of a capable and efficient operation.
- Create/evaluate and release process documentation for new processes.
- Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements.
- Coordinate efforts associated with planning, procuring, installing, and qualifying tooling, fixtures and equipment.
- Train operations personnel on new processes.
- Bachelor's Degree in Engineering, preferably Mechanical Engineering or Manufacturing Engineering.
- Minimum of 5 years of Manufacturing Engineering experience, preferably within the medical device manufacturing industry.
- Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures.
- Experience in structured problem solving and use of statistical tools.
- Training and experience in Lean and Six Sigma, or equivalent.
- Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations.
- This is an onsite schedule position based in Sharon, PA.
- The schedule is: M-F dayshift hours.