Product Safety Engineer
Job Description
Product Safety Engineer
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Note: Go through the Job description an if it looks relevent only then Apply.
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Location: Kalamazoo, MI
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Job Summary
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We are seeking an experienced Product Safety Engineer with a strong background in medical devices to lead product safety, risk management, and regulatory compliance activities throughout the product development lifecycle. This role requires an engineer who has directly owned and led product safety initiatives—not someone with only supporting experience.
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The ideal candidate for this position should have extensive experience with IEC 60601, risk management, EMC/EMI investigations, and medical device regulatory compliance while demonstrating strong technical leadership and the ability to make critical engineering decisions.
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Key Responsibilities
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- Lead and own product safety engineering activities for medical device products from concept through commercialization.
- Drive IEC 60601 compliance activities, including development, verification, validation, testing, and certification.
- Own product risk management activities in accordance with ISO 14971, including:
- Hazard Analysis
- DFMEA/PFMEA
- Risk Controls
- Risk Verification
- Traceability documentation
- Lead EMC/EMI investigations, root cause analysis, corrective actions, and product safety improvements.
- Make and defend technical safety-related design decisions while working with cross-functional engineering teams.
- Ensure compliance with applicable medical device regulations and quality standards.
- Support Design Control activities and maintain Design History File (DHF) documentation.
- Collaborate with Electrical, Mechanical, Systems, Software, Quality, Regulatory Affairs, and Manufacturing teams throughout product development.
- Support regulatory submissions and certification activities.
- Present technical findings and product safety strategies to engineering leadership and cross-functional stakeholders.
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Required Qualifications
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- Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Systems Engineering, or a related discipline.
- 8+ years of Product Safety Engineering experience within the medical device industry.
- Proven experience leading and owning product safety engineering activities.
- Strong hands-on experience with IEC 60601 compliance from product development through certification.
- Extensive knowledge of ISO 14971 risk management processes.
- Experience leading:
- Hazard Analysis
- DFMEA/PFMEA
- Risk Controls
- Risk Verification
- Risk Traceability
- Strong experience conducting EMC/EMI investigations and resolving compliance issues.
- Experience with Design Controls and Design History File (DHF) documentation.
- Strong understanding of FDA medical device regulations and global regulatory requirements.
- Excellent analytical, problem-solving, and engineering judgment.
- Outstanding verbal and written communication skills with the ability to explain complex technical concepts clearly.
- Demonstrated leadership in cross-functional engineering environments.
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Preferred Qualifications
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- Experience supporting Class II or Class III medical devices.
- Experience working directly with regulatory agencies and certification bodies.
- Knowledge of additional medical device standards and quality systems.
- Previous experience leading multidisciplinary engineering teams.
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Preferred Industry Background
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Candidates from the following industries are highly preferred:
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- Medical Devices
- Surgical Devices
- Diagnostic Equipment
- Healthcare Technology
- Life Sciences
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