R&D Senior Systems & Mechanical Engineering Manager

The R&D Senior Systems & Mechanical Engineering Manager for the Reprocessing business leads an R&D team focused on advanced medical device development. This role serves as a technical authority, shaping the technology vision and integrating innovative solutions into product designs.

Note: “R&D Senior Systems & Mechanical Engineering Manager”, Hybrid role requiring 3 days onsite at STERIS Headquarters in Mentor, Ohio.”

• 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.

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

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:

• 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.

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