Medical Device Design Quality Engineer II

Cirtec Medical; Enfield (CT); On-site; USD 89,000 - 108,000; Full time

Benefits offered by this job

Training and career development

Healthcare and well-being programs

Paid Time Off and 401(k)

Job summary

Cirtec Medical is seeking a Quality Design & Development Engineer II to support product development and sustaining manufacturing teams. You will apply design control principles for medical devices, ensuring compliance with FDA 21 CFR 820, ISO 13485, and customer requirements.

As part of cross-functional teams you will create and review design control documentation, lead Design of Experiments, develop risk management plans, and participate in CAPA activities to ensure product safety and quality.

Qualifications

• Bachelor's degree in STEM engineering or related field.
• 2+ years of experience in an engineering environment.
• Knowledge of quality systems and regulatory compliance.

Responsibilities

• Perform Design Quality Engineering activities to ensure compliance with Design Control procedures and regulatory requirements.
• Create, review and approve design control documentation for product development and verification testing.
• Lead and participate in risk management, DFMEA, and root-cause investigations.
• Develop and execute Design of Experiments (DOE) and test methods.
• Support CAPA and quality system improvement initiatives.

Education

Bachelor's degree in STEM

Job description

Cirtec Medical is seeking a Quality Design & Development Engineer II to support product development and sustaining manufacturing teams. You will apply design control principles for medical devices, ensuring compliance with FDA 21 CFR 820, ISO 13485, and customer requirements.

As part of cross-functional teams you will create and review design control documentation, lead Design of Experiments, develop risk management plans, and participate in CAPA activities to ensure product safety and quality.