Systems Design Engineer

1 week ago


Pittsburgh, Pennsylvania, United States Insight Global Full time
Job Title: Systems Design Engineer

We are seeking a highly skilled Systems Design Engineer to join our team at Insight Global. As a key member of our team, you will be responsible for designing and developing medical device systems that meet the highest standards of quality and safety.

Key Responsibilities:
  • Design and develop medical device systems that meet FDA Quality System Regulations and industry standards
  • Collaborate with cross-functional teams to gather user and product requirements and design systems against FMEA requirements
  • Meet with stakeholders, V&V engineers, and development teams to gather requirements, design system workflows, and oversee testing procedures
  • Familiarity with DFMEA/UFMEA/PFMEA, writing technical reviews, CAPA, root cause analysis, risk control, system-level defect analysis, and executing system-level design reviews
Requirements:
  • 5+ years of experience in systems engineering or a related field, with a focus on medical devices
  • Experience with product and user requirements, DFMEA from scratch, and high-level systems design/architecture
  • Knowledge of Medical Device/FDA Quality System Regulations, including ISO 13485/14971/10993/18562/17510/2015 and IEC 62366
What We Offer:

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 without regard to 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.



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