Senior Service Development Quality Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role: 
The Senior 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 Senior 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.

Your responsibilities will include:

• Reduces and controls service process nonconformances by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.  May be responsible for implementing product stops and documenting release criteria
• Develops and implements service quality plans, documents and systems by supporting the creation service plans, product-specific service processes, and service risk analysis in conjunction with other product development team members.  May be responsible for risk analyses
• 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
• Supports internal and external regulatory audits

Required qualifications: 

• BS in Industrial, Biomedical, Mechanical, Electrical Engineering, or related degree
• Minimum of 5 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 <10%, if required

Preferred qualifications: 

• 5+ years of medical device engineering experience preferred
• Strong communication and presentation skills
• Experience supporting Medical Electrical Equipment (MEE)
• Experience supporting MEE Service
   

 

Requisition ID: 590532

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsi