Product Safety Engineer - medical Devices, IEC 60601-1
Motion Recruitment
irvine, California, United States
$80-$100 an hour
Full-time
Our client, located in South Orange County, is one of the largest medical device makers within the optical surgery space.
They are urgently seeing a Laboratory Safety Engineer to work hands-on in their Labs on the medical devices. They continue to grow their departments and add new engineers monthly.
This is a hybrid 4x a week onsite position, so they would need to be local to the south orange county area or norther San Diego.
Role Requirements :
Minimum Education and Experience :
BS + 4+ years in medical device products safety compliance, and / or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
- Working 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 successfully being able to work with cross functional teams
Core responsibilities :
- Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
- Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams
- Capable of performing safety testing and of Alcon products in the Alcon 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
- Communicate with internal / external labs, technicians, and design engineers to accomplish timely / valuable results at optimal cost (from Quote request to final deliverables).
- 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).
- Experience with Safety testing of electrical equipment and certification for global market access.
- Experience with Product Safety testing requirements and procedures.
- Experience with use and maintenance of commonly used safety equipment, and calibration procedures.
- Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and / or fully accredited test labs.
The Offer :
- 80-100 / hr pay rate DOE
- W2 Employee Benefits
- potential for full-time offer after the contract is over.
Motion Recruitment partners
You will receive the following benefits :
- Medical Insurance - Four medical plans to choose from for you and your family
- Dental & Orthodontia Benefits
- Vision Benefits
- Health Savings Account (HSA)
- Health and Dependent Care Flexible Spending Accounts
- Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance
- Hospital Indemnity Insurance
- 401(k) including match with pre and post-tax options
- Paid Sick Time Leave
- Legal and Identity Protection Plans
- Pre-tax Commuter Benefit
- 529 College Saver Plan
3 days ago