Development Engineer II

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

The Development Engineer II is accountable for design, development, documentation, and verification activities for new and existing medical devices. The Development Engineer II is responsible for product lifecycle tangibles including testing execution, data collection, risk management traceability, and design input/output specifications. This position is learning independently, working within a cross functional team, developing technical skills, contributing to product knowledge, and advancing expertise in the quality system requirements.

What You'll do as a Development Engineer II

• Independently executes the design, development, release, and sustaining activities for medical devices.
• Interpret and evaluate data from various sources including research, testing, and/or marketing investigations to determine the performance requirements that can be incorporated into the product.
• Observe and understand product performance from various settings including benchtop, animal labs, user engagements to influence future verification and validation requirements.
• Generate and maintain design control documentation, including requirements, outputs, and traceability.
• Develop, execute, and document verification test protocols and reports.
• Support verification and validation planning activities.
• Analyze and solve technical problems using established tools and methods.
• Apply sound judgment in task execution and escalate issues appropriately.
• Translate user and project needs into technical requirements in collaboration with cross functional partners.
• Develops testing protocols and reports that capture key details, decisions, and rationale that are used for various purposes including notified bodies (e.g. FDA - 510k) documentation, sterilization, biocompatibility, feasibility, verification and validation.
• Participate in design reviews and provide value added technical input. Communicate proactively regarding status, risks, and deliverables.
• Contribute to continuous improvement efforts by suggesting process enhancements.
• Adheres to corporate standards and department operating procedures.

The Experience, Abilities and Skills Needed

• Bachelors Degree in Engineering or similar field
• 3+ years of relevant work experience
• Experience independently executing design and development tasks
• Experience authoring design control documentation
• Experience developing and executing verification test protocols
• Working knowledge of medical device regulatory and quality requirements

The Preferred Experience, Abilities and Skills

• Preference for independently owning assigned technical scope
• Experience working cross functionally with Quality, Manufacturing, and Marketing
• Interest in participating in design reviews and technical discussions
• Desire to expand responsibility with limited supervision
• Interest in continuous improvement and process enhancement
• Independent technical problem solving skills
• Ability to apply judgment and escalate issues appropriately
• Clear technical communication using facts and data
• Ability to manage multiple tasks and priorities
• Growing understanding of business and project objectives

What STERIS Offers

At STERIS, we invest in our employees and their families for the long term! STERIS wouldn’t be where it is today without our incredible people. We share our success together with you by rewarding you for your hard work and achievements.

Here is just a brief overview of what we offer:

• Competitive Pay
• Extensive Paid Time Off and (9) added Holidays.
• Excellent healthcare, dental, and vision benefits
• 401(k) with a company match
• Long/Short term disability coverage
• Parental Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Continued training and educations programs
• Excellent opportunities for advancement in a stable long-term career
• #LI-KS1 #LI-Hybrid

Pay range for this opportunity is $80,000 - $95,000. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit .

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 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.