R&D Senior Systems & Mechanical Engineering Manager (Mentor, OH, US, 44060)

Steris Corporation•Mentor, OH

71d•Hybrid

About The Position

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 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."

Requirements

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.

Nice To Haves

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

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.