Description
Temporary Mechanical Engineer at STERIS Corporation
6+ Month Assignment, Possible Temporary-to-Permanent Opportunity
Summary :
This position is responsible for the products manufactured at the STERIS Hopkins facility. This position supports manufacturing, design improvements and modifications, process improvements, product transfer and continuous improvements at the Hopkins Plant.
Essential Job Functions :
1. Designs and develops product and process improvements. Supports current product line and new products. Uses Pro-E and Auto-Cad to develop and change designs and document them.
2. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope or several projects of smaller in size or scope.
3. Performs work which involves conventional engineering practice, but may include a variety of complex features such as conflicting design/process, quality and customer requirements. Works with internal team and external suppliers to resolve design, manufacturing and quality issues. Performs evaluations and tests to understand and improve the products or manufacturing processes. Develops designs, cost estimates, manufacturing processes and coordinates integration.
4. Creates/coordinates Bills of Material (BOM), electrical schematics, electrical circuits, piping/plumbing schematics, pneumatic diagrams, mechanical assembly drawings, component drawings, and all other engineering documents required to support product line/ upgrades. Processes/Coordinates engineering changes and product documentation in a timely manner.
5. Participates in CAPA and continuous improvement projects. Participates in audits, investigations, tests, evaluates internal and external mfg. processes and technologies. Interfaces with vendors and other outside specialists. Supports compliant process, failure investigations and material review boards.
6. Validates new processes and products. Develops flow charts and validation protocols. Performs DOE, DFMA, process capability studies and PFMEA as required. Engages in strategies for reducing cost, improving quality and productivity by applying lean and six sigma methodologies.
7. Other duties as assigned by Hopkins engineering manager.
Working Conditions :
Air conditioned atmosphere maintained. Standing, sitting, walking, bending, crouching, and lifting (70 lbs. maximum) during equipment testing. Keyboard work at computer monitor is necessary. Ability to travel is required. Must wear safety shoes and safety glasses on manufacturing floor.
Education/License Requirements :
Bachelor’s Degree in Mechanical Engineering and equivalent experience. Advanced degree is an advantage.
Requirements:
· A minimum of 7-10 years of experience in the engineering field with 1-2 years in a FDA/GMP regulated manufacturing environment is required .
· Strong experience with validation of equipment is required
· 5+ years of experience with Auto-Cad is required
· Three to four years hands–on experience in Pro-E preferred. Excellent understanding of files management and documentation. Experience in component design, manufacturing, materials and testing of equipment is required. Experience in Medical Device development, design transfer, design for manufacturability (DFM), reliability and cost is preferred.
· Excellent knowledge of fluid mechanics, mechanical, electrical and software is preferred. Experience in machine design and automation preferred. Knowledge of Programmable Logic Controllers (PLC's), motion control, process control, and sensors preferred.
· Knowledge of design and manufacturing of sterilizers for decontamination and medical applications is preferred.
· Excellent problem solving and trouble shooting skills in pneumatic, mechanical, and electrical sub-systems.
· Excellent leadership skills in interacting with and leading cross-functional teams.
· Excellent organizational, interpersonal, oral and written communications skills.
· Excellent project management skills and experience in handling multiple projects. Able to adapt to changing priorities. Sense of urgency in resolving conflicts and implementing changes.
· Must be highly motivated and a team player with enthusiasm and high energy, has strong interpersonal skills and a demonstrated record of driving results.
· Proficiency in advanced manufacturing processes and automation technologies preferred. Knowledge of Value Stream Mapping, JIT, Lean/Flow Manufacturing. OSHA and Safety regulations knowledge is beneficial.
· Must have a strong understanding of statistics , DOE and Six Sigma applications. Working Knowledge of process equipment and process control. Must have validation experience in developing and executing IQ, OQ and PQ and Minitab application.
· Proficiency in MS Word, Excel, Visio, MS project and PowerPoint.