Cirtec Medical · 20 hours ago
Sr. Quality Design & Development Engineer
Enfield, CT
Full-time
Onsite
Senior Level
5+ years expCirtec Medical is a leading outsourcing partner for complex medical devices, specializing in comprehensive solutions for Class II and III devices. The Sr. Quality Design & Development Engineer is responsible for Design Control, regulatory compliance, and quality functions, including data analysis and manufacturing support.
Medical Device
Responsibilities
Develop and perform operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments
Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments
Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements
Generate the Quality Plan for development projects
Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection
Create appropriate sampling plans along with identifying inspection and acceptance criteria
Review and/or document Design Control activities for Project Phase Reviews and Product Verification testing as required per project requirements
Perform vendor audits and qualifications
Represent quality engineering in phase reviews and other aspects throughout product development
Manage the internal audit system schedule and perform the duties of a Lead Auditor including training internal auditors
Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting
Member of customer and 3rd party quality audit team. May be required to lead this effort
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s
Provide trending analysis on CAPA, NMR and other quality metrics
Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
Qualification
Required
A Bachelor's degree in a STEM Engineering field
5+ years of experience in Quality Engineering
Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
Extensive experience with medical device QSRs in design control and production environments
Strong familiarity with Class II or Class III medical devices requirements
Knowledge of FDA/cGMP and MDD regulations/guidelines
Experienced with ISO13485
Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office
Must possess excellent verbal communication, organizational, and management skills
Strong verbal and written communication skills including technical report writing
Ability to work with a wide variety of functional areas including R&D, Manufacturing, and QA, accomplishing results with minimal guidance
Must be able to read, write, and speak fluent English
Demonstrated use of Quality tools/methodologies including Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R
Preferred
CQE certification
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Whether you’re a cutting-edge startup or a leading Class II or III medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.
1001-5000 employees
H1B Sponsorship
Cirtec Medical 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 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Brian Highley
CEO
John Kraus
Chief Operations Officer
Recent News
2025-10-02
2025-09-17
2025-08-29
Company data provided by crunchbase