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Job Title:  Senior Development Engineer

Req ID:  17383
Job Category:  Engineering
Country/Region:  US
State:  OH
City:  Mentor
Zip:  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

US Endoscopy, a division of STERIS Corporation, is a world leader in endoscopy device design and manufacturing, serving the U.S. and International GI endoscopy markets. We are a new product development company and work closely with physicians and nurses worldwide to deliver innovative solution-oriented products that address everyday clinical challenges faced by our Customers. The foundation of our culture is built on trust, mutual respect and collaboration – encouraging one another to grow and positively impact our business and Customers every day.

 

The Senior Development Engineer will have prior experience in the medical device industry. They are the conduit between design engineering and project management, while working closely with clinical, manufacturing, regulatory, etc. You will have responsibility for various aspects of engineering within new product development from requirements gathering through production and market launch. This position is for someone who thrives on being hands on and interacting with co-workers from various parts of the business, develop and present project updates, develop testing protocol,  become involved in 510k submissions and patent preparation and even interact with clinicians.  

What you will do
  • The Senior Development Engineer position is responsible for the development, and release of new unique gastrointestinal endoscopy devices solutions to meet the Customer’s unmet needs. 
  • Work with a cross-functional team to identify user needs and translate those to product specifications.
  • You will be responsible for design control documentation and testing including input/output specifications, risk management documents, output verification protocols, accelerated aging, and biocompatibility testing.
  • You will work within a cross-functional team structure to ensure that the assigned project meets  engineering deadlines and budgets.
  • Your work will also include ensuring that collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, intellectual property, and strategic fit within the product portfolio.
  • Interpret and evaluate data from engineering research and/or marketing investigations to determine the performance requirements that will be incorporated into the product and observe device/prototype performance in lab or initial market release for future verification and validation requirements.
What you need to be successful
  • Bachelor's Degree in Mechanical or Biomedical Engineering required
  • A proven history of developing medical devices from concept through production with 5 or more years of  experience  within the medical device industry required
  • Understanding of medical device regulatory, document, and quality control issues.
  • Ability to review and understand project timelines, identify key tasks and milestones, and be able to create an engineering plan that reduces technical risks in order to meet the overall schedule.
  • Understanding of processes related to reviewing existing and protecting novel Intellectual Property.
  • Fluent in Microsoft Office Applications (e.g. Word, Excel, PowerPoint, Outlook, etc..)
  • Experience in 3-D solid modeling/drawing environment (SOLIDWORKS preferred)

 

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.

 

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STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates 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.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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