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Quality Design Engineer
- A leading medical device manufacturing company located near Danbury, CT
- Hiring a Quality Design Engineer focusing on design control
About Our Client
Located near the Danbury, CT area - our client is a leading medical device manufacturing company that provides diagnostic technology that saves lives every single day!
The Quality Design Engineer will provide design assurance support in the development of medical device products, and facilitate the application of design controls and V&V system/software validation. The incumbent will provide design assurance support to various manufacturing sites and contract manufacturers when design changes are required. Other responsibilities include:
- Actively participate on new product development projects ensuring that product design inputs are clear, concise, testable and appropriate and that design outputs confirm compliance to the design inputs.
- Participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, within product teams and updates to existing product lines.
- Review and approve design verification and validation test plans, protocols and reports. Ensure V&V results demonstrate compliance to medical device standards
- Review test methods for quality of verification and validation of the method.
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
- Participate in continuous improvement of design control process and project management planning.
The Successful Applicant
The preferred candidate for the Quality Design Engineer will have the following background and experiences:
- Skilled in requirements analysis, including testable and measurable specifications
- Experience with test methods and standards for the design, verification, and validation of medical device products
- Skilled in test plan development and root cause failure analysis
- Familiar with reliability analysis and test methods and test method validation
- Working knowledge of IEC60601, IEC62366, EN62304
- Good verbal (including presentation) and written communication skills, especially technical report writing
- Ability to effectively work on project teams
- Ability to appropriately assess written design and device documentation as the principle advocate for compliance
- Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Working knowledge with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
- Skilled in statistical methods and design of experiments
- Manufacturing engineering or manufacturing quality engineering experiences a plus
What's on Offer
Competitive compensation, great benefits and growth opportunities within a world class organization!