Principal Systems Engineer (Mentor, OH, US, 44060)

Steris Corporation•Mentor, OH

33d•Hybrid

About The Position

The Principal Systems Engineer within the Reprocessing business will be responsible for technical leadership, technical realization of new features or evolving existing features and instilling systems and platform engineering mindset. 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. Note: "Principal Systems Engineer (51729), Hybrid role requiring 3 days onsite at STERIS Headquarters in Mentor, Ohio."

Requirements

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.

Nice To Haves

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

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.