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:

  • 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

  • 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

  • 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

  • Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained

  • Lead the development, validation and implementation of inspection and test methods (including training of inspection and test personnel)

  • Lead cross functional teams to implement risk assessment and risk management processes

  • Provide documentation to support regulatory submission activities and review content for compliance to QSR regulations

  • Participate in cross functional teams to review and evaluate impact of proposed supplier changes

  • Provide support to complaint management and post market surveillance organization by completing robust and timely complaint investigations

  • Develop, coordinate and perform technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)

  • Develop statistical process control methodologies to achieve required levels of product reliability

  • Analyze quality performance indicator data and investigate adverse trends to identify variables that may potentially affect product and processes

  • Identify opportunities to implement design changes to improve system and/or process reliability, reduce scrap rates and improve yields and efficiencies

  • 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:

  • BS Degree in Mechanical, Electrical or Biomedical Engineering

REQUIRED EXPERIENCE:

  • 5+ years engineering experience (Engineer) or 8+ years engineering experience (Senior)

  • 3+ years Class II or Class III medical device experience (Engineer) or 6+ years Class II or Class III medical device experience (Senior)

  • Demonstrated knowledge of FDA Quality System Regulation, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices

  • Significant experience working with new product design/development projects or sustaining engineering projects

  • Experience in complying with Design Controls and mentoring other organizations regarding Design Control requirements and expectations

  • Strong organizational skills and ability to prioritize workflow to meet established time frames and schedules

  • Able to constructively collaborate with cross-functional teams

DESIRED EXPERIENCE:

  • Experience with injection molded components, including; Mold Qualification, First Article Inspection Process Validation and Process Controls

  • Experience with electro-mechanical devices including electrical safety testing

  • Process validation expertise related to manual assembly processes

  • ASQ Certification (Certified Quality Engineer, Certified Quality Manager)

  • Demonstrated ability to act as Subject Matter Expert related to Design Controls, Device History Files, Master Validation Plans, DFMEAs and PFMEAs

  • Experience supporting regulatory agency inspections and notified body audits as SME

 

 

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