BayOne Solutions · 22 hours ago
Principal Quality Engineer
Marlborough, MA
Contract
Onsite
Lead/Staff
$69.71/hr - $69.71/hr
8+ years expBayOne Solutions is seeking a Principal Quality Engineer to join their team. The role focuses on the design and development of medical devices and in vitro diagnostics, emphasizing design control and risk management. The candidate will be responsible for ensuring compliance with FDA regulations and quality management systems.
Information and Communications Technology (ICT)Information ServicesInformation TechnologySaaSSoftware
Hiring Manager
Nikhil Nawani
Responsibilities
Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management is preferred
Experience in working effectively in an FDA-regulated environment
Experience working with IVD products
Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA)
Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
Required to wear PPE as appropriate when visiting testing locations
Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
May be required to travel by airplane /train or drive long distances
Ability to follow verbal or written instructions and use effective verbal and written communication
Experience with quality management system development, Design Controls, and risk management
Qualification
Required
Bachelor's Degree or higher
8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management
Experience with quality management system development, Design Controls, and risk management
Preferred
ASQ Certification preferred & Regulatory Affairs Certification (RAC)
Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management
Experience in working effectively in an FDA-regulated environment
Experience working with IVD products
Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA)
Company
BayOne Solutions
BayOne Solutions provides computer programming services.
501-1000 employees
H1B Sponsorship
BayOne Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (25)
2023 (20)
2022 (30)
2021 (20)
2020 (37)
Funding
Current Stage
Late StageLeadership Team
Yogesh Virmani
CEO and Co-founder
Rahul Sharma
President and Co-founder
Recent News
Company data provided by crunchbase