Principal Service Development Quality Engineer

2 months ago

Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full time
About the Role

We are seeking a highly skilled and experienced Principal Service Development Quality Engineer to join our Global Capital Equipment (CE) Quality Assurance team within the Service Development Quality Engineering group. This role will provide Service Development Quality Engineering support to both Service Development and Field Service Engineering, ensuring the delivery of high-quality products to our customers.

Key Responsibilities
  • Assist product and service development teams in ensuring the development and commercialization of top-quality products, directly impacting our customer experience.
  • Lead efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions to reduce and control service process nonconformances.
  • 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.
  • May be responsible for risk analyses and product performance monitoring by identifying critical service processes and devising methods to reduce nonconformances and 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, sustain product design, and new product development.
  • Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
  • 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.
  • Experience supporting Medical Electrical Equipment (MEE) and MEE Service.

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    Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full time

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    Job SummaryWe are seeking a highly skilled Principal Service Development Quality Engineer to join our Global Capital Equipment (CE) Quality Assurance team within the Service Development Quality Engineering group. This role will provide Service Development Quality Engineering support to both Service Development and Field Service Engineering, ensuring the...

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    Moose Jaw, Saskatchewan, Canada Boston Scientific Gruppe Full time

    Job SummaryWe are seeking a highly skilled Principal Service Development Quality Engineer to join our Global Capital Equipment (CE) Quality Assurance team within the Service Development Quality Engineering group. This role will provide Service Development Quality Engineering support to both Service Development and Field Service Engineering, ensuring the...

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