Cirtec Medical
Quality Design & Development Engineer I
Cirtec Medical, Enfield, Connecticut, us, 06082
Unlock your potential in medical device design, development, and manufacturing with Cirtec.
At Cirtec, collaboration fuels our success. We believe in harnessing the power of diverse perspectives and skills across departments and locations to drive groundbreaking advancements in medical device design, development, and manufacturing. Our global team is the heartbeat of our mission, with every member making vital contributions to push the boundaries of innovation in the medical device industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation. Explore our career opportunities to learn how you can embark upon a fulfilling career with Cirtec today. Position Summary: The Quality Design & Development Engineer I is responsible for providing support to product development teams and sustaining manufacturing/operations teams. This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy. Key Responsibilities: Perform Design Quality Engineering activities throughout the design, development, and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485). Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams. Create and execute Quality Plans for Product Design and Development projects. Represent Quality Engineering in technical design and phase end reviews. Develop and perform Design of Experiments (DOE). Develop and validate test methods. Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques. Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality. Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances. Support quality system improvement initiatives and CAPA’s. Responsible for the assessment of technical standards, labeling and technical file requirements. Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications. Perform requirement flow down analysis on critical to quality product performance specifications down to components and process. Apply Design for Reliability and Manufacturability tools and techniques. Support for multiple projects, balancing priorities, and resources to meet both project and management expectations. Prepare reports required by the project or department management. Reliable, consistent, and punctual attendance is an essential function of the job. Complies with company, quality, and safety standards, policies, and procedures. This is not a remote position. Must Have: Bachelor’s Degree in an Engineering related field required. Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations. Knowledge of product development processes and methods. Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation. Must be able to read, write and speak fluent English. Knowledge in the application of risk management. Good to Have: ASQ Certification.
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At Cirtec, collaboration fuels our success. We believe in harnessing the power of diverse perspectives and skills across departments and locations to drive groundbreaking advancements in medical device design, development, and manufacturing. Our global team is the heartbeat of our mission, with every member making vital contributions to push the boundaries of innovation in the medical device industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation. Explore our career opportunities to learn how you can embark upon a fulfilling career with Cirtec today. Position Summary: The Quality Design & Development Engineer I is responsible for providing support to product development teams and sustaining manufacturing/operations teams. This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy. Key Responsibilities: Perform Design Quality Engineering activities throughout the design, development, and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485). Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams. Create and execute Quality Plans for Product Design and Development projects. Represent Quality Engineering in technical design and phase end reviews. Develop and perform Design of Experiments (DOE). Develop and validate test methods. Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques. Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality. Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances. Support quality system improvement initiatives and CAPA’s. Responsible for the assessment of technical standards, labeling and technical file requirements. Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications. Perform requirement flow down analysis on critical to quality product performance specifications down to components and process. Apply Design for Reliability and Manufacturability tools and techniques. Support for multiple projects, balancing priorities, and resources to meet both project and management expectations. Prepare reports required by the project or department management. Reliable, consistent, and punctual attendance is an essential function of the job. Complies with company, quality, and safety standards, policies, and procedures. This is not a remote position. Must Have: Bachelor’s Degree in an Engineering related field required. Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations. Knowledge of product development processes and methods. Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation. Must be able to read, write and speak fluent English. Knowledge in the application of risk management. Good to Have: ASQ Certification.
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