Senior Design Assurance Engineer 9/2/2016

Medical Device Organization Danbury, CT

Company
Medical Device Organization
Job Classification
Full Time
Company Ref #
29461130
AJE Ref #
576077380
Location
Danbury, CT
Job Type
Regular

JOB DESCRIPTION

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SENIOR DESIGN ASSURANCE ENGINEER

LOCATION: Danbury, CT

The Senior Design Assurance Engineer 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 various manufacturing sites and contract manufacturers.

ESSENTIAL DUTIES & RESPONSIBILITIES

* 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.

QUALIFICATIONS

* 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

Preferred Skills/Qualifications:

* 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 engineeringexperiences a plus

Education

* BS in an engineering discipline

EXPERIENCE

* 3-5 years of engineeringexperience, preferably with V&V system/software validation
* Strong 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