Senior Project Engineer - EMC, Product Safety and Environmental Testing

Siemens Healthineers AG; Newark (NJ); On-site; USD 98,000 - 134,000; Full time

Benefits offered by this job

medical insurance

dental insurance

vision insurance

401(k) retirement plan

life insurance

disability insurance

paid parking/public transportation

paid time off

paid sick and safe time

Job summary

Siemens Healthineers is seeking a Compliance Project Engineer to plan, coordinate, and deliver compliance testing projects in a regulated environment. You will be the primary interface between product-development teams and the laboratory, defining test scope, contracts, scheduling, and documentation while ensuring approvals and traceability.

The role requires experience with EMC/product safety/environmental standards, project planning, and strong stakeholder coordination.

Qualifications

• Bachelor's degree in Engineering or related field
• Minimum of 5 years of engineering, compliance, test, project or product development experience in a regulated industry
• Working knowledge of EMC, product safety, environmental, or certification standards (IEC 61326, IEC 61010, IEC 60601)
• Experience with project planning, technical documentation, scheduling, and stakeholder coordination
• Strong written, verbal, organizational, analytical and problem-solving skills
• Proficiency in Microsoft Office applications and ability to learn lab document/record-management systems

Responsibilities

• Plan and coordinate EMC, product safety, and environmental testing projects
• Define test scope, inputs, configurations, standards, acceptance criteria, schedules, and deliverables
• Prepare and maintain test plans and STL contracts and coordinate approvals
• Issue test reports and data packages and coordinate reviews for design verification deliverables
• Evaluate deviations from STL contracts and decide on revisions
• Coordinate laboratory capacity, personnel, equipment, facilities, and external resources
• Track test execution, issues, changes, failures, retests, and corrective actions
• Ensure plans, reports, approvals, and records are complete and stored
• Interpret standards and coordinate with CBTL and certification bodies when needed
• Support audit readiness with accurate project records and evidence
• Communicate project updates to stakeholders and leadership
• Participate in cross-training and knowledge transfer
• Support hands-on testing or report preparation as needed
• Perform additional laboratory/project duties as required

Skills

In vitro diagnostics

Regulated environment

EMC knowledge

Test project coordination

Risk management

Stakeholder coordination

Education

Bachelors degree in Engineering

Tools

Microsoft Office

Job description

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 Compliance Project Engineer plans, coordinates, and delivers compliance testing projects from intake through final report issuance. This role is the primary interface between product-development teams and the laboratory, and is responsible for test scope definition, test contracts, scheduling, standards interpretation, documentation, approvals, and project deliverables in an accredited, regulated environment.

Key Responsibilities

• Plan and coordinate assigned EMC, product safety, and environmental testing projects in accordance with laboratory procedures, testing strategies, project commitments, and applicable standards.
• Work with customers and engineering teams to define test scope, required inputs, test articles, configurations, applicable standards, acceptance criteria, schedules, and deliverables.
• Prepare and maintain test plans and STL test contracts, and coordinate the required customer, technical, and quality approvals.
• Issue test reports and data packages, and coordinate subject‑matter expert and quality review and approval for design verification deliverables.
• Evaluate deviations from an STL test contract and determine, with laboratory management, whether a contract revision or a new contract is required, ensuring the basis for the decision is documented.
• Coordinate laboratory capacity, personnel, equipment, facilities, and external resources, and escal ...
• Track test execution, open issues, configuration changes, failures, retesting, corrective actions, and decisions through project completion.
• Ensure test plans, reports, approvals, and supporting records are complete, traceable, controlled, and stored in the required systems and repositories.
• Interpret applicable standards and coordinate with technical experts, CBTL, and national certification bodies when requirements, scope, or conclusions require clarification.
• Support audit readiness and audit responses by providing accurate project records, technical evidence, status, and corrective‑action information.
• Communicate clear and timely project updates to internal stakeholders and leadership, including risks, resource conflicts, schedule changes, and decisions required.
• Participate in cross‑training and structured knowledge transfer, including capture of standards expertise and lessons learned from experienced laboratory personnel.
• Support hands‑on testing, technical troubleshooting, or report preparation when needed and within demonstrated competency.
• Perform additional laboratory and project responsibilities as assigned by the Senior Manager based on demonstrated competency, workload, and organizational needs.

Desired Skills for Success in this role

• Experience operating and maintaining in‑vitro diagnostic products.
• Experience coordinating compliance, certification, verification, or product‑development projects in a regulated environment.
• Familiarity with ISO/IEC 17025, IECEE CTF programs, quality systems, audit preparation, and controlled technical records.
• Working knowledge of EMC, product safety, and environmental testing standards used for medical or in‑vitro diagnostic equipment.
• Experience with risk management, configuration control, corrective actions, and formal technical communication.
• Ability to influence cross‑functional teams, resolve ambiguity, and maintain momentum across competing priorities.

Required skills for the success in this role

• Bachelors degree in Engineering, a related technical field or an equivalent combination of education and relevant experience.
• Minimum of 5 years of engineering, compliance, test, project or product‑development experience; regulated industry experience preferred.
• Working knowledge of applicable EMC, product safety, environmental, or certification standards, including the IEC 61326, IEC 61010, or IEC 60601 series.
• Demonstrated experience with project planning, technical documentation, scheduling, and stakeholder coordination.
• Strong written, verbal, organizational, analytical, and problem‑solving skills.
• Proficiency in Microsoft Office applications and the ability to learn laboratory document and record‑management systems.

Work Environment and Expectations

Full‑time, onsite role located in Newark, Delaware. The position operates in a hands‑on laboratory and product‑development environment and may require occasional overtime, domestic travel, manual handling of equipment or test articles, and collaboration with global teams.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

Base Pay Range

The base pay range for this position is:

$98,140 - $134,937

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan.
• life insurance
• long‑term and short‑term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and affirmations all qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you're unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice

California residents have the right to receive additional notices about their personal information. To learn more, click here.

Export Control

A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

Data Privacy

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.

To all recruitment agencies

Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.