Lead Engineer responsible for designing and validating test equipment and programs for power electronics. Collaborating with engineering teams to ensure high - quality product development and testing processes.
About the role
- Staff Quality Engineer overseeing TRB and Global Change Control processes at Johnson & Johnson. Leading continuous improvement in quality systems within the medical device sector.
Responsibilities
- Lead and moderate Technical Review Board meetings and document decisions.
- Administer and improve Global Change Control processes.
- Ensure compliance with ISO 13485, 21 CFR 820, and ISO 14971.
- Partner cross-functionally to assess and mitigate risk.
- Track metrics and drive continuous improvement initiatives.
- Work with originator and SMEs to explain required changes.
- Connect across engineering, RA/QA, operations, and manufacturing teams.
- Identify workflow inefficiencies and propose improvements.
Requirements
- Bachelor’s degree in Engineering or related field.
- 6+ years of medical device quality engineering experience.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Vacation –120 hours per calendar year.
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year.
- Holiday pay, including Floating Holidays –13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year.
- Caregiver Leave – 80 hours in a 52-week rolling period.
- Volunteer Leave – 32 hours per calendar year.
- Military Spouse Time-Off – 80 hours per calendar year.
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