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The Manufacturing Engineer I position is responsible for the products manufactured at the STERIS Eden Prairie facility. This position supports manufacturing, design improvements and modifications, process improvements, product transfer and continuous improvements.
Job Responsibility:
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
Plans, schedules, conducts or coordinates detailed phases of the engineering work
Performs work which involves conventional engineering practice
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
Creates/coordinates Bills of Material (BOM), piping/plumbing schematics, pneumatic diagrams, mechanical assembly drawings, component drawings, and all other engineering documents
Processes/Coordinates engineering changes and product documentation
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
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
Requirements:
Bachelors Degree in Engineering required
4 years experience in the engineering field required
Experience in component design, manufacturing, materials and testing of equipment is required
Must have validation experience in developing and executing IQ, OQ and PQ
Knowledge of Value Stream Mapping, JIT, Lean/Flow Manufacturing
Knowledge of fluid mechanics
Working Knowledge of process equipment and process control
Understanding of statistics, DOE and Six Sigma applications
Understanding of file management and documentation
Problem solving and trouble shooting skills in pneumatic and mechanical sub-systems
Nice to have:
Hands on experience in manufacturing setting preferred
Experience in machine design and automation preferred
FDA/GMP regulated manufacturing environment is preferred
Hands–on experience in Pro-E preferred
Lean manufacturing experience preferred
Medical Device manufacturing experience preferred
Experience in Medical Device development, design transfer, design for manufacturability (DFM), reliability and cost is preferred
Experience in an ISO audited manufacturing company preferred
Proficiency in advanced manufacturing processes and automation technologies preferred
OSHA and Safety regulations knowledge is beneficial
Minitab application preferred
Knowledge of design and manufacturing of sterilizers for decontamination and medical applications is preferred
What we offer:
Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care