Job Title:  Senior Manufacturing Engineer

Req ID:  41762
Job Category:  Manufacturing Operations

Mentor, OH, US, 44060


At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

At STERIS, the Senior Manufacturing Engineer is responsible for the New Product Introduction at the STERIS Mentor Manufacturing Center (MMC). This position will lead or support introduction of new products to production in a manufacturing environment including the creation of new production lines. You will also support design improvements and modification, process and product improvements, design transfer and continuous improvements initiatives. 

What We Offer You

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing: 

  • Competitive salaries 
  • Healthcare benefits 
  • Tuition assistance 
  • Paid time off 
  • Paid holidays 
  • Matching 401(k) 
  • Annual merit increases 
  • Annual bonus 

Join us and help write our next chapter.

What You Will Do

•    Lead design transfer efforts for the introduction of new products to production at STERIS manufacturing sites. Including development of production line, process validation, manufacturing planning, and documentation per established Steris requirements.
•    Lead insourcing of existing STERIS products to STERIS manufacturing sites
•    Design and development of new products or accessories of small to moderate size using CAD (Creo). Including the creation of Bills of Material (BOM), mechanical assembly drawings and component drawings in Windchill (PLM), and all other engineering documents required to support product line and upgrades.
•    Support product improvement projects for sustainability of existing products by processing and coordinating engineering changes and product documentation in Windchill (PLM).
•    Plans, schedules, conducts, or coordinates detailed phases of the engineering work in a part of a major project or in a total project of various scopes utilizing project management tools and strategies.
•    Propose, support, and participate in continuous improvement projects to improve safety, quality, delivery, process efficiency, cost, and manufacturability.
•    Validates new processes (VMP) and products. Develop flow charts and validation protocols. Performs DFMA, process capability studies and FMEA as required.
•    Perform initial costs estimation at the beginning of projects and creates mBOM structures in MRP system (Syteline) to establish final standard cost for new products during design transfer.
•    Design and develop tooling and fixtures along with required work instructions for making products.
•    Directly supervises technical or process support positions in accordance with the company’s engineering systems, medical device manufacturing requirements, lean manufacturing procedures, and quality systems requirements.
•    Perform work which involve conventional engineering practices but may also 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.
•    Other duties as assigned by engineering manager.

What Will Help You Be Successful

Bachelor’s Degree in Mechanical Engineering or equivalent is required. Advanced degree is helpful.

•    Minimum five (5) to eight (8) years in manufacturing engineering or similar role preferred.
•    One (1) – two (2) years in an FDA/GMP regulated manufacturing environment is preferred.
•    Three (3) to four (4) years hands–on experience in Creo. Experience using MRP and PLM is 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) and reliability is preferred.
•    Experience in fabrication is a plus.
•    Ability to ensure accuracy of work. 
•    Excellent problem solving and trouble shooting skills is preferred.
•    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 to product design.
•    Knowledge of Value Stream Mapping, JIT, Lean/Flow Manufacturing. OSHA and Safety regulations knowledge is beneficial.
•    Must have a strong understanding of statistics. Working Knowledge of process equipment and process control.
•    Validation experience in developing and executing IQ, OQ and PQ is preferred.
•    Proficiency in MS Word, Excel, Visio, MS project and Power Point. 




STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

Req ID:  41762
Job Category:  Manufacturing Operations

Mentor, OH, US, 44060

Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Manufacturing Engineer, Medical Device Engineer, Medical Device, Mechanical Engineer, PLM, Engineering, Healthcare, Management