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Job Title:  Senior Product Development Engineer

Req ID:  30117
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

STERIS is seeking a highly driven Senior Product Development Engineer for our Endoscopy business unit. Development Engineers at STERIS Endoscopy are responsible for the development and release of innovative products to better diagnose, prevent and treat disease of the gastrointestinal tract. The projects you will focus on our patient impacting electromechanical capital devices and associated consumables. Product Development Engineers work within cross-functional teams, with physicians, vendors, and other outside resources to turn user needs into viable solutions. Product Development Engineers are responsible for facilitating design and development of products, design controls, risk management, product qualification, product clearance, and product release.

If you are interested in developing cutting edge therapeutic endoscopy products this is an excellent opportunity for you!
*This position is located in Mentor, Ohio and  offers a hybrid work model.
 

Duties

A STERIS Endoscopy Senior Product Development Engineer:
•    Leads and facilitates the design and development of products from project selection to full market release. Drives and ensures compliant documentation of key project decisions, design trade-offs, design controls, risk assessments, design reviews, risk management activities, usability, product qualification, and product release. Manages project risk, develops plans and contingencies for likely failures or challenges. 
•    Develops expertise in FDA regulations, quality management systems, business processes, lean methodologies, design controls, product development lifecycle, biocompatibility, intellectual property, and other relevant knowledge areas. 
•    Maintains a sense of urgency for projects and cross-functional team members and other departments through effective prioritization and communication. 
•    Works with clinicians, physicians, and product managers to obtain feedback on design ideas and prototypes early and often. Analyzes and troubleshoots product performance during labs and clinical use for potential improvements.
•    Solicits, interprets, evaluates, and integrates inputs from customers, clinical, marketing, quality, regulatory, manufacturing, and other engineers. Clearly articulates trade-offs and creates solutions with associated design and compliance documentation. 
•    Communicates clearly and effectively, especially regarding key changes to project scope, quality, timeline, and expenses. Presents project updates to technical and non-technical audiences effectively (meetings, presentations, etc.).
•    Works effectively with others in a cross-functional team environment. Builds trust with team members and within the organization. Maintains project momentum within the organization. Works closely with team members to overcome challenges.
•    Supports a high-performance culture built on trust, respect, community, and a continuous improvement spirit. Identifies areas for improvement and offers potential solutions.
•    Effectively manages multiple projects and/or responsibilities concurrently, while adapting to changing needs and priorities. Prioritizes tasks appropriately and delivers on project deliverables and milestones. Maintains a sense of urgency. 
 

Required Experience

•    Bachelor’s degree in Biomedical, Bioengineering, Systems, Electromechanical, Electrical, or Mechanical Engineering
•    5+ years of capital medical device engineering experience 
•    The ability to adjust according to the situation, learn new things, innovate, and try new methods
•    The ability to function as part of a team, placing the success of the whole above the needs of the self
•    A desire to explore the unknown and question the status quo in pursuit of better, more effective solutions
•    Effective communication skills with confidence to present before groups of customers, vendors, peers, and leadership
•    Ability to travel domestically to observe clinical usage, attend conferences, and participate in animal or bench tests

Preferred Experience

•    Experience with medical device product development: user needs definition, design, prototyping, analysis, testing, design controls, risk management, regulatory submissions, clinical evaluation, manufacturing processes, process qualification, verification and validation activities, and commercialization.
•    Previous experience working in a regulated environment, specifically medical device regulations
•    Understanding of medical device regulations and quality management systems
•    Proficiency with Microsoft Office with a strong ability to write reports and correspondence
•    Proficiency developing test plans, test methods, test protocols, and test reports
•    Experience leading medical device projects from concept through production 
•    Experience with CAD software, preferably SolidWorks
•    Experience with designing for manufacturability, service, inspection and assembly
•    Experience with Human Factors and Usability Engineering
•    Experience with Lean Product Development and/or Lean Manufacturing
•    Experience with products that involve mechanical, software, and electrical aspects
•    Project Management Experience
 

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 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:  30117
Job Category:  Engineering

Mentor, OH, US, 44060


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

Job Segment: Biomedical Engineering, Medical Device Engineer, Testing, Medical Device, Product Development, Engineering, Technology, Healthcare, Research