Senior Project Engineer - EMC, Product Safety and Environmental Testing

Siemens Healthineers AG; Newark (DE); On-site; USD 98,000 - 135,000; 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 time

Job summary

Siemens Healthineers AG is seeking a Compliance Project Engineer to plan, coordinate, and deliver compliance testing projects from intake to final report. You will interface with product development and the laboratory, defining test scope, contracts, schedules, and approvals within an accredited, regulated environment.

The role focuses on EMC, product safety, and environmental testing, collaborating with customers and engineering teams to ensure timely, compliant deliverables and robust

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Minimum 5 years engineering, compliance, test, or product development experience in a regulated industry.
• Familiarity with IEC 61326, IEC 61010, or IEC 60601 series.
• Experience with project planning, technical documentation, scheduling, and stakeholder coordination.
• Strong written, verbal, organizational, analytical, and problem-solving skills.
• Proficiency in Microsoft Office and laboratory document management systems.

Responsibilities

• Plan and coordinate EMC, product safety, and environmental testing projects.
• Define test scope, inputs, configurations, and acceptance criteria with customers and engineering.
• Prepare and maintain test plans and contracts and coordinate approvals.
• Issue test reports and data packages and obtain design verification approvals.
• Evaluate deviations from contracts and manage contract revisions.
• Coordinate capacity, personnel, equipment, facilities, and external resources.
• Track test execution, issues, retests, and corrective actions.

Skills

In vitro diagnostics

Regulatory compliance

Project coordination

Stakeholder communication

Risk management

Documentation

Education

Bachelor's 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 elevate risks to scope, quality, schedule, cost, or safety.
• 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.

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.

• 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 Affiantive Action Employer encouraging diversity in the workplace. 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.

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.

Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.

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.”