Senior Manager of EMC, Product Safety and Environmental Testing

Siemens Healthineers

8d•$147,740 - $203,137•Onsite

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. The Senior Manager is accountable for the safe, compliant, and effective operation of the Systems Testing Laboratory (STL) and holds overall leadership responsibility for all EMC, product safety, thermal-humidity, altitude, and environmental testing. The role leads the people, resources, priorities, quality, and accreditation readiness of the laboratory, and builds the technical bench needed to support medical and in-vitro diagnostic products through development, verification, and certification.

Requirements

Bachelors degree in Engineering or a related technical field.
Minimum of 7 years of System Engineering, Test Engineering, Hardware Engineering, Manufacturing Engineering, and/or Software Engineering experience in a product development environment.
Minimum of 3 years of technical, project, and/or people leadership experience in the medical device industry.
Knowledge of EMC, product safety, and environmental testing for medical and IVD devices, with demonstrated experience with the IEC 61326, IEC 61010, and IEC 60068 series.
Demonstrated ability to make risk-based decisions balancing quality, safety, technical validity, resources, and schedule.
Critical and clear thinker with strong interpersonal, written, and verbal communication skills.

Nice To Haves

Practical experience acquired in an engineering product development environment, working across different product life cycles in design change and new product development projects supporting diagnostics products.
Working knowledge of the product certification process, ISO/IEC 17025 requirements, and IECEE CTF programs, including audit response and corrective action.
Excellent communication and negotiation skills to work with auditors, internal stakeholders, CBTL, and national certification bodies (NCBs).
Experience in project and technical planning of design change and new product development projects.
Passion for people leadership, talent development, and knowledge transfer, with a continuous learning mindset and a strong commitment to quality deliverables.
Ability to influence and work collaboratively with cross-functional, global teams, and to prepare and present technical and operational updates to senior leadership teams.

Responsibilities

Hold overall leadership responsibility for the day-to-day operations, strategic direction, and personnel of the STL, including all test chambers and all EMC, product safety, thermal-humidity, altitude, and environmental testing activities.
Set testing priorities and manage laboratory capacity and schedules, translating business priorities into clear direction for engineering and technical staff and align laboratory work with project commitments and company deadlines.
Manage resource planning, including inputs into project budgets, staffing, contractors, equipment needs, and facility requirements, and respond to changing business priorities with timely updates to overall laboratory testing plans.
Be responsible for the quality and timeliness of deliverables to internal customers and stakeholders, including the Chief Engineers Office, Systems Engineering, Hardware/Design Engineering, Commercial Product Engineering, Manufacturing, and Customer Services teams.
Lead a team of engineers from diverse fields and ranges of experience, guiding professional growth through talent assessment, mentorship, and development of bench strength.
Ensure all required laboratory capabilities remain covered by assigning and periodically rebalancing responsibilities among qualified personnel based on competency, workload, and availability, while retaining accountability for technical integrity, quality, safety, schedule, records, and customer deliverables.
Own onboarding, competency development, documented qualification and authorization, cross-training, and periodic reassessment of STL personnel.
Establish and maintain a phased knowledge-transfer and succession plan for critical technical and compliance capabilities.
Maintain laboratory compliance and audit readiness for ISO/IEC 17025, IECEE CTF requirements, and third-party certification body test lab (CBTL) audits, including controlled test records, competency evidence, equipment status, and technical documentation.
Act on internal, customer, accreditation, and certification-body audit findings, ensuring corrections, corrective actions, and improvement actions are implemented, documented, and closed in a timely manner.
Ensure equipment calibration, maintenance, verification, measurement traceability, measurement uncertainty, environmental controls, sample identification, configuration tracking, and retention of test records are effectively managed.
Ensure the team's compliance with all quality procedures and policies of product development, and maintain laboratory safety, including electrical, high-voltage, RF, equipment, material-handling, environmental, and emergency requirements.