Sr Design Quality Engineer

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Job ID Number: 2014009226 Location: USA - CT - North Haven Job Description This Design Quality Engineer will join a new product development team working on the development and support of Covidien’s next-generation minimally invasive platform. In this role the design quality engineer functions as the quality representative on a cross-functional team responsible for design verification, reliability engineering, component specification and approval, process evaluation and nonconforming product analysis. ESSENTIAL FUNCTIONS: This QA functional representative is responsible for: Managing the Risk Management Process per ISO 14971 and integrating it into the over-arching Risk Management Process for the entire platform. Ensuring that all tasks are conducted in accordance with Quality System procedures. Facilitating and managing Design, Process and Usability FMEAs in a research and development setting. Ensuring that Reliability Plans are developed, approved, and carried out throughout the development and qualification processes. Contributing to the development of Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses. Developing Quality inspection procedures, including sampling plans, for both production level components and finished devices. Developing and maintaining Device Master Records and Device History Records for both production level components and finished devices. Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions. Responsible for ensuring all FDA and ISO validation requirements are met and for the review and approval of all validation protocols (IQ, OQ, PQ and MSA). Provide guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices. Bachelor's Degree in Engineering, Math, Physical Science, or equivalent with5 or more years experience with at least 3 years of related experience with new product development in a regulated industry Preferred Experience: 5+ years of experience in medical device development, or developing complex electro-mechanical and/or robotic systems in a regulated industry. Skills/Qualifications: Knowledge of Standards Applicable to Medical Device Safety Risk Management (CFR 820, ISO 13485, ISO 14971, ISO 62303, IEC 60601-1, and related standards) Experienced in the practical application of Reliability Engineering and System Engineering principles Knowledge of Design Control Systems and ability to apply project management techniques Experience with supplier management and component qualification practices Experience managing a comprehensive risk management process for complex medical devices Strong leadership skills with the ability to influence without direct authority Experience with Minitab or similar statistical analysis tools Experience with Geometric Dimensional and Tolerancing (GD&T) Green or Black Belt Six Sigma Certification (DFSS or DMAIC) Fundamental understanding of electronic and electromechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external - See more at:
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Quality Assurance

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