Systems Test Engineer II

Insight Global is looking for a Systems Test Engineer/Design Quality Engineer, to play a critical role in supporting medical device product development from concept through commercialization. This position is embedded within a high-performance, cross-functional sustaining team, ensuring the safety, quality, and compliance of launched products while continuously enhancing their commercial value through end-of-life. The engineer is responsible for developing test methods and equipment to meet product requirements, supporting lab activities such as creating clinical phantoms for device evaluation, and executing design fabrication using additive manufacturing techniques like 3D printing. They actively contribute to a collaborative team environment, apply systematic problem-solving methodologies to resolve quality issues, and support verification, validation, and usability testing to meet internal and external standards. Additionally, they demonstrate proficiency in validation and statistical techniques aligned with regulatory requirements, produce technical documentation to support development processes, and apply knowledge of human anatomy and physiology to ensure effective medical device usage.

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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

- Bachelor's degree in Biomedical Engineering, materials engineering, chemical engineering, bioengineering, biomedical engineering, material science
- 0-2 years of experience in design assurance, new product development,
- Lab experience from class/research

- Medical Device background/highly regulated background
- ISO 13485, ISO 14971 and quality system regulations
- Testing and or automated equipment experience
Measurement system analysis experience

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.