Gentuity, LLC · 1 month ago
Design Quality Engineer – Systems
Sudbury, MA
Full-time
Hybrid
Mid Level
3+ years expGentuity, LLC is focused on ensuring regulatory and quality compliance for their products. The Design Quality Engineer will lead design control deliverables, conduct risk management activities, and provide support during regulatory audits while collaborating with cross-functional teams.
Health CareManufacturingMedical Device
Responsibilities
Lead and support new product development design control deliverables for Software/Hardware products
Lead Risk management activities including FMEAs, hazard analysis and other risk management file documents
Maintains and audits Design History Files
Support Process/Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities
Provide quality and compliance support during regulatory audits and responses to government agency questions
QA Lead for CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies)
Responsible for the review and approval of manufacturing verification and validation protocols and test reports
Participate in the design control and review processes, including quality planning
Perform quality driven statistical analysis
Lead activities for maintaining and updating standards across the design history file and product requirements
Lead new supplier qualification activities for hardware and software components
Support obsolescence and design changes for hardware components in production
QA Lead on the Software Review Committee
Maintain and manage product risk management files
Support Post-Market Reporting activities for disposable products (e.g. Periodic Safety Update Report, Post Market Surveillance Reporting, and Post Market Clinical Follow-up Reporting)
Support other projects or activities as assigned
Qualification
Required
Minimum of a bachelor's degree in science, engineering, or other related technical discipline
3 – 5 years of experience with engineering and development
Proficient understanding in medical device design controls and risk management regulations such as ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, ISO 14971
Knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required
Experience with Software development cycle
Able to effectively manage workload and deliverables
Excellent verbal and written communication skills
Thrives in a small size company and cross-functional team driven environment
A responsible team player that takes initiative and has a solution driven mindset
Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
Preferred
ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE), preferred
Company
Gentuity, LLC
Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today’s best-in-class technologies.
51-200 employees
H1B Sponsorship
Gentuity, LLC 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
2023 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
David W. Kolstad
Chief Executive Officer
Christopher Petersen
Co-founder and Senior Vice President
Recent News
2025-09-09
Medical Product Outsourcing
2025-08-13
Company data provided by crunchbase