Motion Recruitment Partners LLC
Product Safety Engineer
Motion Recruitment Partners LLC, California, Missouri, United States, 65018
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 northern 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 3rdEd (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:
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.
#J-18808-Ljbffr
This is a hybrid 4x a week onsite position, so they would need to be local to the south orange county area or northern 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 3rdEd (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:
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.
#J-18808-Ljbffr