Gentuity, LLC · 22 hours ago
Design Quality Engineer - Catheter
Sudbury, MA
Full-time
Hybrid
Mid Level
3+ years expGentuity, LLC is focused on ensuring regulatory and quality requirements for new products and design changes. The Design Quality Engineer will lead verification and validation processes, support risk management activities, and collaborate with cross-functional teams to maintain product compliance and drive process improvements.
Health CareManufacturingMedical Device
Responsibilities
Lead and support new product development design control deliverables for Catheter/Disposable or Software/Hardware products
Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained
Lead Risk management activities including FMEAs (Process, Design, & Use), hazard analysis and other risk management file documents
Maintains and audits Design History Files
Support the review and approval of Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities
Supports the generation and completion of protocols and reports for product, process, and test method validations. (IQ/CQ/MSA/OQ/PQ)
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 the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence
Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies
Conduct Supplier Audits and investigations as needed
Supports and leads supplier qualification process
Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications
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 statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)
Proficiency in the use of root cause analysis tools (i.e. FMEA, Fishbone Diagram, 5 Why, 8D, etc.)
Experience and demonstrated proficiency in Process Validation (IQ, OQ, PQ, TMV)
Able to effectively manage workload and deliverables
Ability to read and interpret drawings
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
Detail oriented with strong organization skills
Ability to work cross functionally and as part of a project team
Self-Motivated and strong ability to adapt to change
Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
Preferred
Experience with catheter products or optical imaging technology preferred
ASQ Certified Quality Engineer (CQE), 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