Boston Scientific Principal Service Development Quality Engineer 

United States, Minnesota, Arden Hills 

407378493

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
• 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

Required qualifications:

• 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 <10%, if required

Preferred qualifications:

• Strong communication and presentation skills
• Demonstrated ability to influence cross-functional partners
• Experience supporting Medical Electrical Equipment (MEE)
• Experience supporting MEE Service

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.