Principal Design Quality Engineer

Boston Scientific • Maple Grove, MN

1d

About The Position

Responsible for design control and risk management of next-generation medical devices Uses clinical knowledge to influence how devices 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) 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

Requirements

• Bachelor's degree in engineering or science discipline, or equivalent.
• Minimum of 8 years experience in design assurance, quality, or related medical device or regulated industry experience
• ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
• Strong communication skills (verbal & written) and presentation skills
• Problem solver, capable of facilitating the problem-solving process & driving issues to closure
• Excellent organizational and planning skills; drives for results
• Travel approximately up to 20%
• Focus on detailed work with emphasis on accuracy and completeness
• Ability to collaborate and work on a highly matrixed and global team
• Experience mentoring and leading a team
• Experience with Class II & III Medical Devices

Responsibilities

• Design control and risk management of next-generation medical devices
• Influence how devices are tested and designed
• Identifying, prioritizing, communicating, and resolving quality issues
• 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)
• 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
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees