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Principal Service Development Quality Engineer

2 months ago

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

The Principal Service Development Quality Engineer will join our expanding Global Capital Equipment (CE) Quality Assurance team within the Service Development Quality Engineering group, supporting BSC'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.

The Principal Service Development Quality Engineer is responsible for assisting product and service development teams to ensure the development and commercialization of top-quality products, directly impacting BSC's customer experience.

Key Responsibilities
  • Reduce and Control Service Process Nonconformances
    • Lead efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions.
    • Implement product stops and document release criteria.
  • Develop and Implement Service Quality Plans
    • Support 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.
  • Collect and Analyze Field Product Performance
    • Systematically gather quality metric data and perform analysis to enhance service processes, sustain product design, and new product development.
  • Create Quality Tools and Training Materials
    • Apply body of knowledge and expertise to communicate with respective teams.
  • Evaluate Systems and Operations
    • Ensure compliance with regulation and company documentation.
    • Audit areas of the BSC quality system, such as Service Development, Service Support, and Field Service Operations, as assigned.
  • Participate in Global Installation and Servicing Community
    • Identify opportunities and drive improvements.
  • Support BSC Teams
    • Work across functions, product technologies, and cultures to support teams globally.
  • Apply Problem-Solving Methodologies
    • Identify, prioritize, communicate, and resolve quality issues.
  • Lead Improvement Projects
    • Sustain the Quality Strategy, ensuring Best Culture, Best Agility, Best Performance, and Best Compliance.
  • Provide Direction and Coaching
    • Support service development quality engineering and technical team personnel.
  • Lead Projects
    • Manage risks and resource requirements.
  • Support Regulatory Audits
    • Internal and external audits.
Requirements
  • Education
    • BS in Industrial, Biomedical, Mechanical, Electrical Engineering, or related degree.
  • Experience
    • Minimum of 7 years of medical device engineering experience.
  • Skills
    • In-depth familiarity with the FDA, ISO, MDD, EU MDR, and medical device industry quality requirements.
    • Solid technical writing skills.
  • Travel