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Principal Service Development Quality Engineer
2 months ago
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.
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 by leading efforts/teams focused on identifying the 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.
- May be responsible for implementing product stops and documenting release criteria.
- 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.
- 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
