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Principal Service Development Quality Engineer

2 months ago

GondrecourtleChâteau, Grand Est, United States Boston Scientific Full time
About the Role

The Principal Service Development Quality Engineer will be part of our expanding Global Capital Equipment (CE) Quality Assurance team within the Service Development Quality Engineering group, supporting Boston Scientific's rapidly growing Medical Electrical Equipment portfolio. This role provides Service Development Quality Engineering support to both Service Development and Field Service Engineering, ensuring that the highest quality products are delivered to customers.

Responsibilities
  • Reduce and control service process nonconformances by leading efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions.
  • Develop and implement service quality plans, documents, and systems by supporting the creation of service plans, product-specific service processes, and service risk analysis in conjunction with other product development team members.
  • Develop and implement product performance monitoring by identifying critical service processes and devising methods to reduce nonconformances in order to reduce/eliminate issues impacting product reliability.
  • Collect and analyze field product performance by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance service processes, sustaining product design, and new product development.
  • Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
  • Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as Service Development, Service Support, and Field Service Operations, as assigned.
  • Actively participate and partner in Global Installation and Servicing community of practice to identify opportunities and drive improvements.
  • Work to support BSC teams across functions, product technologies, and cultures to support teams around the globe.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
  • Support and lead improvement projects to sustain the Quality Strategy, ensuring Best Culture, Best Agility, Best Performance, and Best Compliance.
  • Provide direction, coaching, and mentoring for service development quality engineering and technical team personnel supporting service.
  • Lead projects with manageable risks and resource requirements, and often broader, cross-functional projects.
  • Support internal and external regulatory audits.
Requirements
  • BS in Industrial, Biomedical, Mechanical, Electrical Engineering, or related degree.
  • Minimum of 7 years of medical device engineering experience.
  • In-depth familiarity with the FDA, ISO, MDD, EU MDR, and the medical device industry quality requirements.
  • Solid technical writing skills.
  • Travel