Lead Systems Engineer-Hybrid

Position Summary

The Advanced/Lead Systems Engineer will join the Infection Prevention Technologies R&D team developing new Steam Sterilizers. You will interact with other engineering disciplines and cross functional team member during the development lifecycle phases from concept development through final release. You will be responsible for the overall technical leadership and technical realization of new features or evolving existing features.  You will be the technical stakeholder leading the system level reviews, while working within the project constraints of schedule, cost, performance, quality, and reliability objectives.

*This position is located onsite in Mentor, Ohio with the opportunity for a hybrid work schedule. 

What you will do as a Lead Systems Engineer

•    Drive refinement and translation of stakeholder requirements including safety, clinical application, serviceability, manufacturability, reliability, quality, etc. Additionally, you will translate the requirements management policies of the program and oversee quality of requirements, development of technical approach, top level design, feasibility of potential technical solutions, and allocation of derived requirements, including functionality, interface specifications and design budgets onto affected subsystems.
•    Plan, oversee, and execute the Systems Engineering activities in the project, including initiation, coordination, synchronization, review, and integration of the technical work performed within various Engineering disciplines.
•    Lead cross-discipline feasibility and tradeoff studies, drive system-level design & technical reviews.
•    Lead and/or participate in defect management, risk management, usability activities, preparation of documentation, system integration, verification, and validation.
•    Construct and maintain project schedule.
•    Define testing requirements and strategy.
•    Lead and/or assist in selection of new components such as valves, motors, sensors, materials, etc.
•    Work with Marketing and Regulatory to ensure that products meet user needs and that all regulatory and compliance requirements are met.

The Experience, Skills and Abilities Needed

•    Bachelor's degree in Electrical, Mechanical, or Biomedical Engineering discipline required. Other engineering disciplines will be considered. Master’s degree preferred.
•    8 or more years of involvement in a multi-discipline new product development environment.
•    Previous experience working with regulatory authorities and standards such as ASME, CRN, PED, UL, ISO, MDR, CE, or FDA.
•    Previous electro-mechanical capital equipment experience preferred
•    Systems thinking acuity with understanding and interest in other engineering areas.
•    Ability to work in a highly regulated environment.
•    Demonstrated ability in leading technical analysis, including evaluation of multiple reward solutions.
•    Ability to propose and develop methods, techniques, and evaluation criteria to realize product functionality.
•    Proven technical leadership in a cross-functional environment.
•    Excellent communication, influencing and conflict resolution skills.
•    Excellent technical writing, and presentation skills.

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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