Senior Design Quality Engineer - Interventional Oncology

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 Design Quality Engineer will provide Design Assurance support for New Product Development and Integration for Interventional Oncology (IO) business. This Senior Design Quality Engineer will be responsible for ensuring product quality and compliance, leading the application of Design Control and Risk Management.  In this position, you will work with cross-functional team in achieving new product development, commercialization, and product sustainment within for Interventional Oncology Division of Boston Scientific.

Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN and requires being on-site at least three days per week.

Relocation assistance:

Relocation assistance is available for this position at this time.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

Your responsibilities will include:

• Responsible for design control and risk management of next-generation medical devices
• Uses clinical knowledge to influence how devices they are working on are tested and designed
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
• Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
• Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).
• Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group

What we’re looking for in you:

Required qualifications

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) 
• Self-motivated with a passion for solving problems and a bias for action 
• 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience 
• Strong communication skills (verbal & written) 
• Demonstrated use of Quality tools/methodologies 
• Ability to effectively work and collaborate in a mixed onsite + remote environment 
• Demonstrated experience creating detailed technical documents  

Preferred qualifications

• Experience working with medical devices industry
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Experienced problem solver, capable of facilitating the problem-solving process
• Experience wit