Advanced Systems Engineer

Steris Corporation•Mentor, OH

13d•Hybrid

About The Position

The Advanced Systems Engineer within the Reprocessing business will be responsible for technical leadership and technical realization of new features or evolving existing features on electromechanical medical devices, focusing on systems that measure, analyze and monitor biological indicators to confirm sterilization efficacy. This person will have the opportunity to work cross functionally with multiple engineering disciplines and will be a technical stakeholder within the system level reviews, while working within the project constraints of schedule, cost, performance, quality, and reliability objectives.

Requirements

BS Degree in Engineering discipline required.
Minimum of 8 years of progressive experience in systems engineering.
Minimum of 8 years of involvement in a multi-discipline new product development environment.
Minimum of 8 years of of engineering experience in one area and deep understanding in a second (such as software, electrical, or mechanical engineering)
Previous experience working with FDA regulations and regulatory compliance and familiarity with standards such as ISO, MDR, UL, CE, ASME, CRN, and PED.
Strong understanding of opto-mechanical systems.
Demonstrated advanced systems thinking.
Ability to work in a highly regulated environment.
Demonstrated ability in leading technical analysis, including evaluation of multiple reward solutions.
Demonstrated ability 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.
Excellent technical writing and presentation skills.

Nice To Haves

Master’s degree preferred.

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 oversee 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.
Lead system level optomechanical considerations, including optical performance requirements, optical mechanical interfaces, tolerance allocation, alignment strategies, and integration of optical components with mechanical and electrical subsystems.
Lead planning and execution of Systems Engineering activities for a project, ensuring effective coordination, review, and alignment of technical work across engineering disciplines.
Drive system level design and technical reviews, ensuring readiness, technical rigor, and alignment to requirements.
Lead defect management, risk management, and usability activities at the system level, ensuring timely resolution, appropriate documentation, and effective cross functional communication.
Lead system integration activities, including follow up, analysis, and problem solving, and drives verification and validation execution in collaboration with test, quality, and discipline engineering teams.
Lead system level testing requirements and verification strategies, ensuring appropriate coverage, traceability, and alignment to requirements
Collaborate cross functionally to ensure system level solutions meet user needs and all regulatory and compliance requirements.
Lead and/or assist in developing system architectural platform roadmaps and technology roadmaps and ensuring key software and component decisions align.
Promote and apply functional excellence across projects through best practice guidelines, disciplined technical and design reviews, and LEAN continuous improvement activities.