Systems Design Engineer

Insight Global is looking for 4 Systems Engineering Consultant I for the Pittsburgh area's largest medical device company. The main daily function of this team is to meet with cross-functional teams to gather user and product requirements and design the systems against the FMEA requirements gathered. Members of this team will meet with stakeholders, V&V engineers, and development teams to gather requirements, design the system work flow, and oversee the testing procedure. Familiarity with DFMEA/UFMEA/PFMEA, writing technical reviews, CAPA (corrective and preventative actions), root cause analysis, risk control, system-level defect analysis, and executing system-level design reviews will be crucial in this role.

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 HR@insightglobal.com .

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Required Skills & Experience
- Medical Device background (5+ years doing systems engineering or similar on medical devices)
- Experience with product and user requirements, DFMEA from scratch (design failure mode effect analysis), and high-level systems design/architecture
- Knowledge of Medical Device/FDA Quality System Regulations
EX:
ISO 13485/14971/10993/18562/17510/2015, IEC 62366
Clearance Processes
Great communication/experience sharing a logical story with cross-functional teams and stakeholders

Nice to Have Skills & Experience
- Expertise in Sleep Therapy/Ventilation devices
- SAP

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.