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Senior System Engineer
Senior System EngineerSTERIS • Mentor, OH, US
Senior System Engineer

Senior System Engineer

STERIS • Mentor, OH, US
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Senior Technical Talent Acquisition Partner at STERIS

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 Senior Systems Engineer within the Reprocessing business will be responsible for technical leadership and technical realization of new features or evolving existing features. This person will work cross-functionally with multiple engineering disciplines and will be a technical stakeholder within system level reviews, while working within project constraints of schedule, cost, performance, quality, and reliability.

What You'll Do as a Senior Systems Engineer

  • Drive refinement and translation of stakeholder requirements, including safety, clinical application, serviceability, manufacturability, reliability, and quality.
  • Translate the program's requirements management policies, review quality of requirements, develop technical approach, top-level design, feasibility of potential solutions, and allocation of derived requirements (functionality, interfacing specifications and design budgets) onto affected subsystems.
  • Plan, oversee, and execute Systems Engineering activities in the project, including initiation, coordination, synchronization, review, and integration of technical work across engineering disciplines.
  • Lead and / or participate in cross-discipline feasibility and trade-off studies; drive system-level design and technical reviews.
  • Lead and / or participate in defect management, risk management, usability activities, documentation preparation, system integration, verification, and validation.
  • Collaborate with Project Management to provide Systems-related tasks and timelines.
  • Assist in developing system architectural platform roadmaps and technology roadmaps; ensure key software and component decisions are aligned.
  • Support establishing functional excellence through best-practice guidelines, technical reviews, design reviews, and LEAN continuous improvement.
  • Work cross-functionally to ensure products meet user needs and regulatory and compliance requirements are met.
  • Lead system integration (follow-up, analysis, problem solving), verification, and validation.
  • Define testing requirements and strategy and drive formal verification and validation.
  • Harmonize common features, system functions, and improvement solutions across relevant products.

Experience, Skills, and Abilities

  • Bachelor's degree in a relevant discipline.
  • Minimum of 5 years of progressive experience in systems engineering, with involvement in a multi-disciplined project development environment.
  • 5+ years of engineering experience in one area with deep understanding in a second area (such as software, electrical, or mechanical engineering).
  • 5+ years of experience in requirements management and risk analysis; 5+ years of experience in medical device product development.
  • Experience working with regulatory authorities and standards such as ASME, CRN, PED, UL, ISO, MDR, CE, or FDA.
  • Strong systems thinking and leadership in a matrix environment; ability to influence indirect resources.
  • Excellent communication, influencing, conflict resolution, and technical writing and presentation skills.

    • What STERIS Offers

    We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is a brief overview of what we offer :

  • Competitive pay
  • Extensive Paid Time Off and holidays
  • Healthcare, dental, and vision coverage
  • 401(k) with company match
  • Maternity and paternity leave
  • Additional benefits / discounts for programs such as pet insurance
  • Tuition reimbursement and continued education programs
  • Opportunities for advancement in a stable, long-term career

    • Job Details

  • Seniority level : Mid-Senior level
  • Employment type : Full-time
  • Industries : Hospitals and Health Care

    • Location and salary details vary by posting. Sign in to set job alerts for "System Engineer" roles.

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    Senior System Engineer • Mentor, OH, US