Safety Risk Engineering Expert | Boston, MA or Orlando, FL - Hybrid | Contract | No OPT / NO CPT

Overview

Hybrid
Depends on Experience
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

Medical Devices
ISO 9000
FTA
FMEA
Risk Analysis
Research and Development
Software Development
Embedded Systems

Job Details

Title: Safety Risk Engineering Expert
Location: Onsite Choose one: Boston, MA or Orlando, FL
Type: 12 Months Contract
Work Model: Hybrid (Minimum 3 days onsite per week)

Job Description:
Join a cutting-edge R&D team where Safety Risk Engineering is seamlessly integrated into model-based systems engineering. Be a key player in ensuring the safety, reliability, and innovation of life-saving medical devices.

Key Responsibilities:

  • Drive safety risk management throughout the R&D lifecycle of active medical devices, especially software-driven systems.

  • Collaborate closely with systems engineers and domain experts to embed safety risk engineering into systems engineering workflows.

  • Perform and lead FMEA, FTA, PHA, and other safety analysis activities.

  • Ensure regulatory compliance with ISO 14971, IEC 60601-1, IEC 62304, IEC 62366-1, 21 CFR 820, EU MDR.

  • Create and review documentation to support audits and certifications.

Required Qualifications:

  • Bachelor s or Master s in Systems Engineering, Mechanical/Electrical Engineering, Software Development, or related.

  • 5+ years in medical product development.

  • 3+ years in safety risk management for embedded systems in medical devices.

  • Strong knowledge of applicable FDA and ISO standards.

  • Proficiency in risk analysis methodologies (FMEA, FTA, PHA).

  • Strong cross-functional collaboration and communication skills.

  • German and English language proficiency (verbal and written) is a plus.

Benefits:

  • Hybrid work flexibility (up to 2 days remote)

  • Competitive pay and potential for extension

  • Opportunity to work on high-impact, patient-centered technologies

Apply now to take the lead in shaping safe and innovative medical solutions.

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About Anagha Techno Soft