EMC & Product Safety Compliance Project Lead

Siemens Healthineers AG

Newark (DE)

On-site

USD 98,000 - 135,000

Full time

7 days ago
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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

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

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