Product Development Engineer

The Sr. Requirements Engineer is an important and integral member of the product development organization and whose main function serves to (a) Develop and maintain product requirements documents throughout the product lifecycle, including both pre- launch and post- launch phases, (b) Establish and maintain product requirements and traces between requirements and multiple quality system records. (c) Other responsibilities include providing assistance as necessary in the areas of risk management, decomposition of high- level design requirements into constituent elements, abstraction of low- level details into generalized understanding. The successful candidate is required to have a minimum of a bachelors degree in engineering with specialty in software. A minimum of 4 years experience with full development lifecycle for biomedical products is required. In addition, 7-10 years experience with the medical device industry is required. Demonstrated experience in areas of (a) analyzing and defining customer, product and software requirements for biomedical products, (b) managing requirements through development process, including verifying the fulfillment of all requirements is required. Risk management activities for FDA- approved biomedical products, including risk assessment, risk evaluation and risk mitigation is desirable. Ability to provide technical direction and coordination among engineers and technical support staff is essential. Ability to model visual representations of complex subsystems and behaviors to facilitate understanding among diverse members of the organization is crucial to success. Experience with DOORS or other equivalent product development tools (RHAPSODY) is desirable. Experience with Hematology instruments a plus. Excellent communications skills - written and verbal are essential. Bachelors degree in an engineering or closely related discipline with 4-6 years progressive work experience Interested parties please send resume to amy.borchard@onassignment.com with "engineer" in the subject line. Company:  Lab Support, a division of On Assignment Job Status:  Full Time, Employee Category:  Biotech/R&D/Science Work Experience:  5+ to 7 Years Career Level: Experienced (Non-Manager) Education:  Bachelor's Degree Apply Now! Email this Job to a Friend Click here to see all company opportunities