Quality Design Assurance Engineer
Overview:
Provide technical engineering support to new product development teams and sustaining manufacturing/operation teams. This individual will be expected to apply knowledge of design control principles and quality engineering techniques to development and manufacturing efforts, as a member of one or more cross-functional teams. In parallel, this person shall ensure the products are developed in accordance with applicable regulatory requirements, customer expectations and industry standards.
Essential Responsibilities:
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Collaborate with product design/development engineering, regulatory, clinical, marketing, and other organizational partners to assure appropriate quality requirements are defined and address target patient population
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Support development, implementation and maintenance of Design Verification & Validation (V&V) methodologies and best practices to impact product launch timeliness, improve implementation of design enhancements and reduce number of design iterations
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Work with product design/development teams and manufacturing operations to translate design requirements into manufacturing requirements to increase manufacturability, reduce scrap and improve operational efficiencies
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Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
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Lead the development, validation and implementation of inspection and test methods (including training of inspection and test personnel)
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Lead cross functional teams to implement risk assessment and risk management processes
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Provide documentation to support regulatory submission activities and review content for compliance to QSR regulations
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Participate in cross functional teams to review and evaluate impact of proposed supplier changes
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Provide support to complaint management and post market surveillance organization by completing robust and timely complaint investigations
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Develop, coordinate and perform technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)
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Develop statistical process control methodologies to achieve required levels of product reliability
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Analyze quality performance indicator data and investigate adverse trends to identify variables that may potentially affect product and processes
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Identify opportunities to implement design changes to improve system and/or process reliability, reduce scrap rates and improve yields and efficiencies
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Serve as Subject Matter Expert for regulatory inspections related to Design Controls, Process Validation, Device Master Records and Design History Files
Education/Experience:
REQUIRED EDUCATION:
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BS Degree in Mechanical, Electrical or Biomedical Engineering
REQUIRED EXPERIENCE:
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5+ years engineering experience (Engineer) or 8+ years engineering experience (Senior)
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3+ years Class II or Class III medical device experience (Engineer) or 6+ years Class II or Class III medical device experience (Senior)
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Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices
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Significant experience working with new product design/development projects or sustaining engineering projects
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Experience in complying with Design Controls and mentoring other organizations regarding Design Control requirements and expectations
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Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules
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Able to constructively collaborate with cross-functional teams
DESIRED EXPERIENCE:
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Experience with injection molded components, including; Mold Qualification, First Article Inspection Process Validation and Process Controls
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Experience with electro-mechanical devices including electrical safety testing
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Process validation expertise related to manual assembly processes
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ASQ Certification (Certified Quality Engineer, Certified Quality Manager)
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Demonstrated ability to act as Subject Matter Expert related to Design Controls, Device History Files, Master Validation Plans, DFMEAs and PFMEAs
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Experience supporting regulatory agency inspections and notified body audits as SME