STERIS · 3 hours ago
R&D Medical Design Systems Engineer
Mentor, OH
Full-time
Onsite
Mid, Senior Level
$93K/yr - $124K/yr
5+ years expSTERIS is a company that provides innovative healthcare and life science product and service solutions. The Senior Systems Engineer will be responsible for technical leadership and realization of new features or evolving existing features within the Reprocessing business, working cross-functionally with multiple engineering disciplines to meet project objectives.
BiotechnologyHealth CareMedical Device
Responsibilities
Drive refinement and translation of stakeholder requirements including safety, clinical application, serviceability, manufacturability, reliability, quality, etc
Translate the requirements management policies of the program and review 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 and/or participate in 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
Collaborate with Project Management to provide Systems related tasks and timelines
Lead and/or assist in developing system architectural platform roadmaps and technology roadmaps and ensuring key software and component decisions align
Support establishing functional excellence rigor through best practice guidelines, technical reviews, design reviews and LEAN continuous improvement
Work cross-functionally to ensure that products meet user needs and that all regulatory and compliance requirements are met
Leads system integration (follow up, analysis, problem solving), verification and validation
Defines testing requirements and strategy and drives formal verification & validation
Harmonizes common features, system functions and improvement solutions across relevant products
Qualification
Required
A Bachelor's degree in a relevant discipline is required
A minimum of 5 years of progressive experience in systems engineering
5+ years of involvement in a multi-disciplined project development environment
5+ years of engineering experience in one area with a deep understanding in a second area (such as software, electrical engineering, or mechanical engineering)
5+ years of experience in requirement management and risk analysis
5+ years of experience in medical device product development
Previous experience working with regulatory authorities and standards such as ASME, CRN, PED, UL, ISO, MDR, CE, or FDA
Demonstrated advanced systems thinking skills
Proven ability to lead the evolution of complex systems, requiring evaluation of multiple candidate solutions and significant evaluation of intangibles
Ability to participate in or lead technical analysis, including the evaluation of multiple reward solutions
Capability to propose and develop methods, techniques, and evaluation criteria to realize product functionality
Proven excellence in technical leadership within a matrix environment, including the ability to influence indirect resources
Excellent communication, influencing, and conflict resolution skills
Strong technical writing and presentation skills
Benefits
Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term career.
Company
STERIS
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
10001+ employees
H1B Sponsorship
STERIS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$0.28M2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO
Leadership Team
Daniel Carestio
President and CEO, STERIS
Walter Rosebrough
CEO Emeritus & Senior Advisor
Recent News
2025-11-05
Company data provided by crunchbase