Medical Device Quality Engineer

Job Title: Medical Device Quality Engineer Location: North Haven, CT (100% Onsite)

Experience: 6+ years Duration: 12+ Months Contract

About the Role

We are seeking a Medical Device Quality Engineer to join our Surgical Instruments team, supporting new product development. This role partners with cross-functional teams to ensure product quality, compliance, and continuous improvement. The ideal candidate brings expertise in mechanical and electromechanical design, design verification/validation, process validation, risk management, and complaint analysis within a regulated environment.

Key Responsibilities

Actively participate in product development by reviewing design documentation, performing risk assessments, and defining verification and validation testing requirements.

Drive product risk assessments through tools such as risk management plans/reports, hazard identification, risk analysis charts, and complaint analysis.

Collect, analyze, and interpret statistical data; prepare reports and recommendations for management.

Support design and process validation initiatives, including oversight of system/sub-system requirements, CTQ matrix, process flows, control plans, MSA, and process capability analyses.

Ensure consistent use of quality engineering tools across projects.

Develop and implement solutions for complex engineering challenges aligned with organizational objectives.

Required Qualifications

Bachelor’s degree in Engineering, Math, Physical Science, or related field.

5+ years of experience in engineering or quality (or 4+ years with Master’s degree).

Experience in a regulated industry (medical devices preferred).

Strong foundation in electro-mechanical design and manufacturing processes.

Proficiency with statistical analysis tools (e.g., Minitab).

Experience with risk management tools and methodologies.

Excellent organizational, analytical, and problem-solving skills.

Ability to work independently and in a team environment, balancing multiple projects.

Strong written and verbal communication skills.

Preferred Qualifications

• 6+ years of experience in a regulated industry (advanced degree may substitute for 2 years).

• ASQ Certified Quality Engineer (CQE).

• Knowledge of medical device regulations and standards, including FDA QSR, ISO 13485, ISO 14971, and IEC 60601.

• Experience with software/hardware interfaces.

• Strong project management skills with the ability to prioritize effectively.