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Sr. Design Assurance Engineer

PRINCIPAL RESPONSIBILITIES: * Participate in New Product Development Phase Reviews and Design Reviews. * Lead design control and risk management activities on new and existing products. * Create and support the development and validation of new test methods. * Determine test requirements, investigate/resolve study issues, and perform statistical analysis for verification and validation studies. * Develop the strategy and manage the execution of design verification and validation. * Develop verification, validation, and qualification plans and reports. * Develop, execute, and manage First Articles. * Support regulatory approvals and responses to regulatory questions. * Support Sustaining Engineering for design and process changes to commercialized product. * Define and direct deliverable execution through design assurance engineering technicians. * Ensure design assurance specific quality system deliverables and processes are effective and efficient. * Transfer product development projects from development to production. Note: 50% of this job involves direct R&D activities. EDUCATION / EXPERIENCE REQUIREMENTS: * BA/BS in Engineering or physical sciences required. * Five years of related experience required. SPECIALIZED SKILLS & OTHER REQUIREMENTS: * Ability to define, organize, and manage individual and team based tasks. * Effective verbal and written communication. * Proficient in technical report writing and review. * Interpersonal skills; working in a team and as an individual contributor. * Structured and methodical problem-solving approach. * Thorough understanding of design controls, risk management, statistics, test method validation, and new product development processes. * Understanding of industry regulations such as ISO13485 and FDA QSR's. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Company
Teleflex, Inc
Posted
09/20/2018
Type
Full time
Location
Maple Grove, MN, US