If you enjoy working with solution-oriented, driven colleagues in an agile, bureaucratic-free environment, then come join us at BrightInsight.
The Senior Design Quality Engineer will be working with the product, platform, and software engineering team to provide design control and software/systems development guidance. The Staff Design Quality Engineer will be Design Quality Assurance representative in regulated development activities for various software medical devices solutions.
These solutions include cloud-based applications, mobile, web, and web services that leverage the capabilities of the BrightInsight platform. The BrightInsight platform is a medical IoT, cloud-based platform for the life science industry, and is used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment.
We are looking for someone who thrives in a start-up environment and demonstrates:
- Intensely collaborative
- Passionately focused on the customer
- Detail oriented
- Disciplined executor of responsibilities
- Tenacious commitment to continuous improvement
- Relentless drive to win
- Intense curiosity on technology
- Flexibility and willingness to learn
Here is a glimpse of what you’ll do…
- Active participation in design, development, and deployment activities, working closely with Architects, Engineers, Product Managers, Scrum Masters, and Program Managers.
- Act as the leader in bringing the culture of quality in software medical device development
- Participate and lead Risk Management, Design Assurance, Design Verification, Design Reviews, and Reliability Planning activities
- Assist in the development of SOP's and Work Instructions governing or associated with design control activities/compliance
Here is some of what you’ll need (required)…
- 3+ years of hands-on software development experience
- 5+ years of experience in software medical device development classified as Class 2 and/or Class 3 medical device
- Demonstrated applied expertise in EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, and IEC 62304
- Demonstrated applied expertise in writing different design control deliverables for Class 2 and/or Class 3 medical device software
- Familiarity with SaMD/software-only medical device development
- Experience working with nearshore and/or offshore development partners
- Familiarity with health and data privacy regulations
- Familiarity with the role of Human Factors/Usability in the software development lifecycle
- Position can require up to 30% travel