Loading...
 
Share this Job

Job Title:  Sustaining Engineer

Req ID:  26824
Job Category:  Engineering

Mentor, OH, US, 44060

Description: 

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

If you are interested in a career that helps make it possible for doctors to perform life changing procedures and impact the health and well-being of patients everywhere, then STERIS Endoscopy is the place for you. 

The Sustaining Engineer is responsible for all design aspects of our products after a product is released for production.   Responsibilities include design and design control for product changes that result from supplier changes, quality improvements, and cost reductions.  Projects must be completed accurately, within compliance, and quickly to avoid stock-outs.  The engineer is responsible for assisting in CAPAS, NCR’s, and complaint mitigation.  The position should also suggest areas for improvement in internal processes and create solutions. Help to create streamlined processes for varying tasks.

What you will do

  • Work within cross-functional team structure to ensure projects maintain momentum, meet timelines, and collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, and intellectual property.
  • Responsible for product design including CAD design, prototyping, and design control documentation including input/output specifications and risk management files.  Writing product verification and validation protocols and leading various teams in product risk assessments (dFMEA); maintain design history file documents in accordance with the Quality Management System
  • Work independently or with other engineers as well as clinicians and marketing representatives to review design ideas and prototypes; proactively coordinate, direct, and perform design activities related to GI endoscopic devices and accessories that were previously released for manufacturing.
  • Determine engineering related design control requirements when assigned a project/problem with regards to a currently marketed device. 
  • Interpret and evaluate data from engineering research and/or marketing investigations to determine the performance requirements that will be incorporated into the product. 
  • Work with NPD teams to ensure smooth Design Transfer of New Products into production Work with multiple different groups of people to ensure minimal risk to the production floor (including stock-outs) when introducing a change. 
  • Lead or assist with resolution and mitigation of CAPAS, NCR’s, and complaints.
  • Develop technical knowledge in areas such as materials, plastics, molding, welding, component assembly, and packaging, to effectively design and support the technical needs of the organization.
  • Present project updates to technical and non-technical audiences (project meetings, board meetings, etc.)  This position may be required to solely represent the design function in key meetings.
  • Suggest areas for improvement in internal processes and create solutions. Help to create streamlined processes for varying tasks.

Required Experience

  • Bachelor's Degree in Mechanical, Biomedical or other related Engineering field required
  • 2 years Design Control experience
  • 2 years Mechanical Design Knowledge
  • Minimum 2 years SolidWorks experience
  • Understanding of medical device regulatory, document, and quality control issues
  • Knowledge of IEC and ISO standards surrounding medical electrical equipment, quality systems, and risk management requirements a plus
  • Proven ability to innovate with a history of successful new product releases (medical devices a plus).  Use of a customer driven approach to problem solving and product design is desired.
  • Excellent engineering and organization skills and ability to work independently or within groups.
  • Strong interpersonal skills
  • Excellent verbal and written communication skills
  • Ability to accurately obtain, record, and communicate test data to non-technical personnel.
  • Must be able to travel domestically to observe clinical usage, attend conferences, and participate in animal or bench tests.

What STERIS Offers

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, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

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.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  26824
Job Category:  Engineering

Mentor, OH, US, 44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Gastroenterology, Medical, Manufacturing Engineer, Engineer, Welding, Healthcare, Engineering, Manufacturing