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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 Boston Scientific's customer experience.
Responsibilities- Reduces and controls service process nonconformances by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
- Develops and implements 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.
- Develops and implements product performance monitoring by identifying critical service processes and devising methods to reduce nonconformances in order to reduce/eliminate issues impacting product reliability.
- Collects and analyzes 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.
- Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
- Evaluates 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 participates and partners in Global Installation and Servicing community of practice to identify opportunities and drive improvements.
- Works to support BSC teams across functions, product technologies, and cultures to support teams around the globe.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
- Supports and leads improvement projects to sustain the Quality Strategy, ensuring Best Culture, Best Agility, Best Performance, and Best Compliance.
- Provides direction, coaching, and mentoring for service development quality engineering and technical team personnel supporting service.
- Leads projects with manageable risks and resource requirements, and often broader, cross-functional projects.
- Supports internal and external regulatory audits.
- 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.
- Strong communication and presentation skills.
- Demonstrated ability to influence cross-functional partners.
- Experience supporting Medical Electrical Equipment (MEE).
- Experience supporting MEE Service.
