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Product Safety Engineer / Medical Devices / IEC 60601-1 / Lake Forest

Lake Forest, California

Onsite

Contract

$65/hr - $75/hr

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.

Must have Requirements:

+ Minimum Education and Experience::

+ BS + 3+ 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

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 their products in the 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:

+ 65-75/hr pay rate DOE

+ W2 Employee Benefits

+ potential for full-time offer after the contract is over.

+ optional 401k

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

Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP’s Employment Accommodation policy. Applicants need to make their needs known in advance.

**Posted by:** Kevin Gabrielson

Specialization:

+ Medical / Healthcare Professional