Product Safety Engineer

GTECH LLC; Lake Forest (CA); Remote; USD 80,000 - 100,000; Full time

Job summary

An innovative company is seeking a Senior Product Safety Engineer to ensure compliance with medical device safety standards. This role involves conducting safety assessments, collaborating with teams to drive product development, and preparing detailed documentation for safety certification. Ideal candidates will have a strong background in medical device safety compliance and excellent technical writing skills. Join a forward-thinking organization committed to advancing healthcare technology and making a significant impact on product safety and compliance.

Qualifications

• 4+ years in medical device products safety compliance evaluations.
• Expert knowledge of IEC 60601-1 standards for medical electrical equipment.

Responsibilities

• Perform safety certification test assessments throughout product development.
• Document and execute all V&V tests compliant to medical device QSR.

Skills

Medical device safety compliance

Technical writing

IEC 60601-1 standards

Risk Management (ISO 14971)

EMC test planning

Education

Bachelor's degree in Electrical Engineering or similar

Tools

Safety testing equipment

Documentation tools for safety certification

Job description

2 days ago Be among the first 25 applicants

Direct message the job poster from GTECH LLC

Senior Technical Recruiter | Hiring Full time/Contract - Technical Positions - Remote/Hybrid | Across United States

We have an urgent job requirement from our prime client. If you have relevant experience, please share the resume at [e-mail]

Role: Product Safety Engineer

Location: Lake Forest, CA

Job Type: Full-time

Role Requirements:

• BS (preferably in EE or similar major) + 4 years in medical device products safety compliance evaluations, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
• Expert knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards. Proven experience in application to EM medical devices.
• Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
• Capable of performing safety testing in safety Lab and external labs.
• Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms.
• Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
• Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans and test reports.
• Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
• Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs.
• Strong familiarity with EMC test planning and procedures per IEC 60601-1-2 and associated test practice.

Thanks and Regards,

GTECH LLC

Ashutosh Bharadwaj | Senior Technical Recruiter

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Human Resources Services