Senior Systems Engineer

Position Summary

The Senior Systems Engineer within the Mentor GI sustaining engineering team will provide systems-level technical leadership for changes to existing products. This role will coordinate cross-functional change activity, maintain system documentation as required by those changes, develop and implement engineering design changes, perform verification and validation testing, and support timely design implementation. The position works across engineering, quality, regulatory, manufacturing, service, and other stakeholders to ensure changes are appropriately defined, assessed, verified, validated, documented, and implemented while meeting schedule, cost, performance, quality, reliability, and compliance objectives.

Duties

Provide systems engineering support for sustaining changes to existing products, assessing impacts to requirements, interfaces, safety, usability, serviceability, manufacturability, reliability, quality, and regulatory compliance.

Maintain system documentation as required by change activity, including requirements, risk management files, system architecture and interface documentation, verification and validation records, and related design history documentation.

Coordinate engineering changes from issue definition through implementation, including impact and feasibility assessments, design reviews, risk management, ECR/ECN authoring, deliverable and approval tracking, system integration, and implementation readiness.

Develop and implement engineering design changes and perform associated verification and validation testing, including test setup, execution, results documentation, and issue resolution.

Establish verification and validation requirements, strategies, and acceptance criteria, and provide technical review of stakeholder-authored plans, protocols, and reports for adequacy and traceability.

Support intake and triage of sustaining engineering requests by clarifying the problem, assessing product and system impact, identifying stakeholders and deliverables, and providing input to scope, priority, and resource needs.

Lead or participate in cross-discipline technical reviews, defect investigations, tradeoff studies, component evaluations, and resolution of system-level issues.

Work cross-functionally to ensure sustained products continue to meet user needs and applicable regulatory, quality, and compliance requirements.

Education Degree

Bachelor's Degree

Required Experience

Bachelor’s degree in Electrical, Mechanical, Biomedical or a related engineering discipline.

5+ years of engineering experience in a multidisciplinary, regulated product environment, including sustaining engineering, systems engineering, design changes, or product development.

Previous experience working with regulatory authorities and standards such as ASME, CRN, PED, UL, ISO, MDR, CE, or FDA preferred.

Working knowledge of requirements management, risk management, design controls, and regulatory requirements.

Strong systems thinking and technical judgment.

Effective problem-solving in complex and ambiguous situations.

Strong organization, prioritization, and attention to detail.

Ability to influence and lead across functions without direct authority.

Clear technical writing, communication, and presentation skills.

Pay range for this opportunity is $95,000.00 - $126,000.00 This position is also eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.