STERIS · 2 days ago
Principal Systems Engineer
Mentor, OH
Full-time
Hybrid
Lead/Staff
$142K/yr - $175K/yr
15+ years expSTERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Principal Systems Engineer will provide technical leadership, oversee system engineering activities, and collaborate with cross-functional teams to ensure successful project execution and compliance with regulatory requirements.
BiotechnologyHealth CareMedical Device
Responsibilities
Establishes credibility as a technical expert in systems engineering for complex medical devices
Leads the technology vision of the team; integrates technology into the product; drives and instills systems and platform engineering mindset
Drive decisions on patent strategy and technology roadmaps to support business objectives
Identifies and removes obstacles to facilitate project progress for the team
Promotes communication among project teams to align with organizational goals
Establishes a framework for consistent and measurable execution across projects
Leads cross-functional teams in developing innovative solutions while considering industry trends
Evaluates alternative actions and resources before choosing methods to achieve goals, adjusting strategies as needed based on new information
Balances team needs and desires with available resources while considering both long-term and short-term outcomes
Shares insights on the business, market, and competitive landscape to influence the company’s strategic plan
Provides technical guidance and risk mitigation, emphasizing the importance of technical evolution and obsolescence to the team
Fosters open dialogue within and between teams, creating an environment for idea sharing
Collaborates with various parties to share information and resources for establishing new programs
Recognized as an expert by senior leaders and industry professionals, effectively communicating across all levels
Mentors fellow engineers and shares technical and regulatory expertise to enhance value for the company
Identifies and implements continuous improvements for R&D. Assess and develop associate training and education plans
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
Bachelor's degree in engineering is required
Minimum of 15 years of related experience required
Minimum 10 years of experience systems engineering in R&D for medical devices
Minimum 10 years of experience supporting NPD/LCM programs
Ability to work in a highly regulatory environment
Strong analytical skills
Exposure to project / program management skills required
Must have excellent leadership, interpersonal and influencing skills and have a demonstrated ability to lead global, cross-functional, multi-disciplinary teams. Demonstrated leadership skills including conflict resolution, assertiveness and negotiation skills required
Demonstrated proficiency in driving continuous improvement for performance, quality, time and cost; strong planning and organization skills required
Demonstrated ability to make sound data driven business decisions; Understand, track, drill down and question activities and issues in all functional areas. Strong attention to detail, follow-through skills
Sets the standard for timeliness, work ethic, and personal integrity
Must have excellent written communication skills – reports, presentations
Exceptional team player
Travel up to 5% including internationally
Preferred
10+ years experience developing FDA regulated medical devices
Masters in Engineering Discipline, MBA
Experience in more than one of the following functional areas: Operations, Supply Chain, Quality
Experience in LEAN Methodologies
Experience with Finite Element Analysis and simulation tools
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