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Roles & Responsibilities
Working with customers, marketing, clinical and field personnel to refine requirements, defining customer needs and required feature functionality early in the development cycle.
Translating required functionality to system goals include quality, reliability, usability, serviceability, manufacturability, and cost.
Working across functions and team boundaries to define, design, and implement the next generation of products with an inclusive system design process, especially engaging sub-system and functional teams.
Be responsible for delivery of technical content and quality management deliverables.
Work closely with technical teams to define design from high-level architecture, through technology selection and evaluation.
Act as primary author and reviewer of system architecture, test design, design descriptions and customer documentation.
Conducting trade off studies, and then proceeding with design synthesis.
Driving implementation of the best design, and System Verification & Validation strategy
Leading risk management, design defect management and system design review.
Handling post-production activities include customer complaints analysis, periodic risk assessment and continuous improvement.
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones.
Complete all planned Quality & Compliance training within the defined deadlines.
Education Qualifications
Bachelor’s Engineering Degree in “STEM” Majors (Science, Technology, Engineering and Math)
Required Experience
A minimum of 8+ years of technical & professional experience in Medical Device Industry in the capacity of systems engineer/development engineer/Verification.
Demonstrated experience driving CTQ flow-down to subsystems.
Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product.
Demonstrated broad exposure to systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, System, etc.).
Demonstrated problem analysis and solving ability and results orientation.
Desired Characteristics
Demonstrated experience with ISO and regulatory compliance process, design history file and collaterals are in place and current.
Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
Excellent verbal and written communication skills.
Self-starter, energizing, results oriented, and able to multi-task.
Inclusion and Diversity
Ourare designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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