Description

Position Summary:

The Quality Design & Development Engineer II 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).
• Demonstrated understanding and application of regulations and standards (specifically ISO 14971, 2017/745 EUMDR, IEC 60601, IEC 10993).
• 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.
• Lead and/or participate in reviews and communications with customers.

Must Have:
• Bachelor's degree (STEM engineering discipline required) and 2 years of experience required; or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations.
• Knowledge of product development processes and methods.
• Must be able to read, write and speak fluent English.

Good to Have:
• Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method, and Process Validation.
• Knowledge in the application of risk management.
• ASQ Certification preferred.

Salary Range: 89,000 to 108,000

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.