STERIS · 1 day ago
R&D Senior Systems & Mechanical Engineering Manager
Mentor, OH
Full-time
Hybrid
Senior Level, 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 R&D Senior Systems & Mechanical Engineering Manager leads an R&D team focused on advanced medical device development, serving as a technical authority and integrating innovative solutions into product designs.
BiotechnologyHealth CareMedical Device
Responsibilities
Lead an R&D team in Systems and Mechanical Engineering for advanced medical device development, serving as a technical authority and guiding technology vision
Integrate cutting-edge solutions into products, oversee patent and technology strategy, and ensure efficient project progress
Facilitate clear communication among project teams and stakeholders, standardize execution frameworks, and foster cross-functional collaboration
Evaluate strategies, resources, and alternatives to achieve objectives, balancing immediate needs with long-term goals
Provide market and competitive insights to inform strategic direction; mentor staff in technical and regulatory matters to enhance value
Drive continuous improvement initiatives for R&D, including training, development, and organizational assessment
Oversee stakeholder requirements translation, manage adherence to safety, clinical, serviceability, manufacturability, reliability, and quality standards
Direct Systems and Mechanical Engineering activities throughout project lifecycles, participating in feasibility studies, design reviews, and risk management
Collaborate with Project Management on task definition and scheduling; contribute to system architecture and technology roadmaps
Implement best practices, technical assessments, and LEAN initiatives, ensuring regulatory compliance and user satisfaction
Guide system integration, verification, validation, and problem resolution; define and oversee testing protocols across products
Manage product design, development, and support, including people management, budgeting, and vendor relationships
Ensure workplace safety, security training, and compliance with quality systems, FDA regulations, and company policies
Administer budgets, monitor risks and dependencies, promote high performance, and optimize processes within the department
Qualification
Required
Bachelor's degree in Mechanical Engineering required
Minimum of 15 years of related experience required
Minimum 10 years of experience applying systems engineering in R&D for medical devices
Minimum 10 years of experience supporting NPD/LCM programs
Minimum 5 years of experience managing / directing an R&D Team
5+ years' experience developing FDA regulated medical devices
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 area. 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
Working knowledge with Windchill, CREO, and Microsoft Project
Exceptional team player
Travel up to 10% including internationally
Must have the ability to work in a lab environment & the ability to lift up to 50 pounds
Preferred
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