Design Quality Engineer

Insight Global

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Design Quality Engineer - Risk File Remediation

Livingston, NJ

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Job Description

Insight Global is seeking a Senior Design Quality Engineer (DQE) to support risk management file remediation efforts for a medical device product line of one of our Medical Device clients. This consultant will lead endtoend remediation of risk files to ensure alignment with ISO 14971 and regulatory expectations. This role requires a highly independent Design Quality professional who can take full ownership of risk documentation, facilitate crossfunctional PFMEA sessions, and drive alignment across Engineering, Quality, and Regulatory stakeholders. While the role is largely remote, candidates with proximity to Livingston, NJ or Trumbull, CT sites will be preferred due to faster product familiarization.

They will own and execute full remediation of product risk management files, including:

Risk Management Plans

Hazard Analyses

Risk Management Reports

DFMEAs and UseRelated FMEAs

Review existing risk documentation, identify gaps, and update files to meet ISO 14971 and regulatory standards

Facilitate crossfunctional PFMEA workshops, partnering with Design Engineering, Manufacturing, Quality, and Regulatory teams

Drive risk alignment discussions and ensure consistent hazard traceability across design and use risks

Interface with stakeholders to gather inputs, resolve discrepancies, and finalize inspectionready risk documentation

Ensure remediation activities are completed efficiently with minimal oversight

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ... learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

5+ years of Design Quality Engineering experience in FDAregulated medical device environments

Proven experience leading endtoend risk file remediation independently

Strong working knowledge of ISO 14971, DFMEA, PFMEA, and userelated risk analysis

Ability to facilitate crossfunctional sessions and drive stakeholder alignment - Prior experience supporting risk remediation or inspection readiness initiatives

Familiarity with similar surgical / women's health devices

Ability to ramp quickly with minimal product training or supervision

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