Principal Design Assurance Engineer Manager

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POST DATE 8/31/2016
END DATE 12/19/2016

Medical Device Organization Danbury, CT

Danbury, CT
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Full Time
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The Principal Design Assurance Engineer Manager would work on a range of products and systems that include digital mammography equipment and electronics. You will work in a multi-disciplinary group, contributing to the design and development of innovative products focusing on design control including software development and system/software V&V to support various manufacturing sites and contract manufacturers when design changes are required.


* Partners withEngineering, Operations, Service, Design Assurance, QualityEngineeringand Quality Control to develop and implement processes, procedures, tools and trainings related to the following:

* Design controls such as Quality Function Deployment, Design Verification and Validation, for new product development and sustaining engineering changes
* Risk management throughout the lifecycle of the medical device including the supporting QMS functions
* Process and test method validations for engineering, manufacturing, service and quality processes
* Quality engineering tools such as product, process and service design, product and process controls, quantitative methods and tools, continuous improvement, etc.

* Educates Engineering, Design Assurance and Quality Engineering personnel in regards to design controls and risk management and their practical applications
* 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.
* Directs activities as well as sets goals and objectives for the Design Assurance department


* 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 manage personnel and projects
* Ability to effectively work on project teams

* Ability to appropriately assess written design and device documentation as the principle advocate for compliance

Preferred Skills/Qualifications:

* Excellent working knowledge of Design Control requirements
* Excellent working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
* Strong 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 engineeringexperiences a plus


* BS in an engineering discipline


* 10+ years related experience in an FDA regulated industry with at least five years recent experience with complex electronic, electro-mechanical and/or software imaging medical devices
* Three to five years in management
* Excellent working knowledge of verification and validation in a regulated industry
* 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