Medical Device Software Quality Engineer

• Technical/Functional Skills Experience in Quality Engineering or Assurance with a focus on software testing, design control of software development, software verification and validation. Experience Required
•Minimum 2 years of professional work experience in Quality, R&D, New Product Development, Electrical Engineering, Systems Engineering, Software Engineering, or Computer Science.
•Experience in Quality Engineering or Assurance with a focus on software testing, design control of software development, software verification and validation.
•Application of Design Control fundamentals
•Knowledge of applied statistics and experience with statistical software applications (., Minitab and/or ReliaSoft)
•Knowledge of product/process Risk Management (DFMEA/PFMEA or Gage R&R Analysis, FDA and ISO standards) including cybersecurity assessment.
•Ability to identify and simplify complex issues, as well as demonstrated ability for proactive, organized, and systemic approach to making decisions and resolving issues
•Ability to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills
•Quality Engineering Certification, Software Quality Engineering Certification (., ASQ CQE, ASQ CSQE)
•Certification (., Black belt) in one or more of the Process Excellence roadmaps (., DMADVV, DMAIC, or Lean) Roles & Responsibilities
•The Quality Engineer (Software/Systems) will develop, maintain, and continuously improve the software based medical device and digital products quality capability, ensure compliance with procedures and regulatory expectations for existing and new software medical devices and digital products, and develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches
•Advise and educate key functional partners and management on medical device and digital product requirements, standards and regulations such as IEC 62304, ISO-13485, 21 CFR 820, and EU MDR
•Plan, lead, and execute continuous improvements to the software quality processes
•Provide independent design review for other software medical device programs
•Ensure inspection readiness and maintain CE marks for existing software medical devices
•Employ key company processes to support projects and quality system processes as required by the position, including following quality procedures and add to the quality system documentation, understanding expected outcomes of key quality processes, and creating or updating risk documents via New Product Development, New Process Introduction, and Lifecycle Engineering.
•Utilize Risk management and risk mitigation tools and practices (for example, mistake pr oofing, critical control points, failure modes and effects analysis).
•Conduct reliability assessments of product design.
•Perform root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
•Develop and validate test methods in equipment, process, and product qualifications/validations. Design and execute Measurement Systems Analysis (MSA).
•Implement and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics). Generic Managerial Skills
•Understanding of Engineering principles, Product designs, Product Lifecycle, Design Specifications, Product Requirements and Product mechanisms
•Understanding of Medical Devices and related Regulatory Standards
•Results driven – consistent delivery of targets, deadlines, and commitments.
•Decision quality - sound judgement whilst thinking laterally and innovatively.
•Collaborative and ability to influence throughout the organisation
•Leading people through Change
•Managing Self and organization of others
•Learning agility and a continuous improvement orientation
•Proficient in IT, Microsoft Applications
•Fluent English (verbal and written)
•Able to represent the system to a wide array of individuals (management, technicians, engineers, etc…) and explain at their technical level.
•Must be able to correlate broad array of requests and distill into a single requirement.
•Must be able to navigate complexities of technical ownership with a fast-paced business.
•Able to understand and negotiate trade-offs in timeline, budget, and requirements while maintaining quality of work and data integrity of system.

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