Principal Design 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: 
We have an exciting opportunity for Design Quality Principal Engineer supporting development of single use devices for use with medical electrical equipment/systems (MEE) within the BSC’s Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and new product development experience. The Design Quality Principal Engineer will lead a team of engineers and technicians to apply the directives of design controls during product development. 

Work Mode: 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove, MN office at our Arbor Lakes campus, three days per week. 

Relocation Assistance:

Relocation assistance may be 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 include: 

• 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

What we’re looking for in you:
Required Qualifications:

• 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%

Preferred Qualifications:

• 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

 

 

 

Requisition ID: 620828 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

 

The anticipated compensation listed above and the value of core and optional employee benefit