- You will be leading a matrixed team of global quality, regulatory, engineering and manufacturing professionals in alignment with FDA, EU MDR and other applicable regulations and standards for Ultrasound Intra-Cardiac (ICE) Catheters.
- Work closely with RA partners in providing global regulatory requirements guidance, review and approval process involving device registrations, promotional materials, labeling, product and process changes, documentation etc. to name a few.
- You will provide Quality and Regulatory compliance guidance to Catheter business leaders and cross functional team members throughout product development lifecycle as they execute on product and business imperatives.
- You will be responsible for executing design quality engineering activities for ICE Catheter programs (e.g. review and approval of requirements, design verification, validation methods and protocols etc.)
- Work closely with engineering and manufacturing partners to establish robust product development and manufacturing processes/practices/tools, process validations (IQ/OQ/PQ) and related measurements and metrics (KPIs)
- You will drive and participate in the development of unique design, manufacturing, distribution etc. processes to strengthen the quality and profitability of the Catheter business.
- You will identify and drive continuous improvement opportunities in product lifecycle process compliance and product quality efforts (e.g. Lean, Agile, KPIs, Value Stream Mapping, Structured Problem Solving etc.)
- Work closely with QA partners to drive and implement QS activities such as training, risk management, inspections & audits, defects and complaint handling, CAPA to name a few
- Experience in class III medical device, preferably catheters or similar high-risk devices is a strong plus.
- Strong Product Design and Development experience. Working knowledge of risk management, hazards analysis, corrections and recalls, statistical analysis techniques is a plus.
- Willing to travel up to 10% and schedule flexibility to accommodate global locations
- Good presentation skills when communicating with senior management
- Bachelor of Science in Engineering, Systems Engineering or related field.
- 5+ years of quality/regulatory experience in medical devices, familiarity with global medical device regulations.
- Influential Leader and Clear Communicator, Self-driven Cross-Functional abilities in a global environment is a must
- Expert knowledge of Design Quality Engineering and experience applying ISO 14971/24971 standards to a complex product, and detailed working knowledge of 21 CFR 820, ISO 13485, IEC 60601-1, ISO 10555 standards
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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