Product Safety Engineer

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:

1. 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.

1. Working knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards.
2. Proven experience in successfully being able to work with cross functional teams

Core responsibilities:

• Collaborate cross-functionally within R&D, Manufacturing (MTO, Global Regulatory Affairs including affiliates, QA, suppliers and the Product Certification teams and partner with accredited agencies and NRTL’s to execute the work outlined here
• Monitor relevant standards/editions/amendments and market specific adoptions
• Assess impacts to products and accessories, including their DHF artifacts, during their design / development. Drive updates to DHF artifacts, notably the Risk Management File (ISO 14971), Usability File (IEC 62366?1), PEMS/software lifecycle evidence (IEC 62304), labeling/IFU, and design inputs.
• Plan and execute characterization (testing, analyses, documentation and report creation/updates) as the designs mature through the NPD project lifecycle. Provide quantitative test data and analyses linked to IEC 60601?1 clause (e.g., single fault conditions, creepage/clearance, leakage currents, mechanical strength, thermal, PEMS). Includes timely sharing out of plans with the product team, coordinating on shared prototypes and attending regular meetings to discuss the same and align on project decisions.
• Serve as Safety SME for market submissions including assessing risk of non-conformances and preparing responses to deficiencies as they arise. Identify early compliance risks and design shortfalls before formal type testing
• Advise proactively on design and manufacturing changes with compliance implications as both the design and manufacturing processes are developed. Enable evidence-based design decisions (materials, layouts, insulation systems, firmware behaviors, alarms) that reduce cost/schedule risk in formal compliance
• Meet timeliness and deliver on these activities as the product teams outline business needs. Ensure timelines remain in sync to development plan changes as they occur
• Provide these services on a time and material basis as outlined by the project leadership during the appropriate team meetings

The Offer:

• 65-90/hr pay rate DOE
• W2 Employee Benefits
• potential for full-time offer after the contract is over. 

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.