Boston Scientific Design Quality Assurance Engineer II 

United States, Minnesota 

779579899

Spencer Gregory Hale

Your responsibilities will include:

• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Learn, use, and teach the most effective engineering tools to optimize designs of WATCHMAN devices – Design Failure Modes and Effects Analysis (DFMEA), Benchmarking, predictive tools, etc.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Serve as an effective quality leader or team member on a cross-functional team
• Own and drive deliverables related to Design Controls, Product Performance, Quality, and Compliance.
• Review and approve quality records, including product specifications, design verification test protocols, design verification test reports
• Partner cross-functionally to identify and support value improvement efforts to support business goals
• Support internal and external audit activities
  

What we're looking for in you:
Required Qualifications

• Bachelor’s degree in an engineering related discipline
• Minimum of 2 years of experience in design assurance, new product development, quality, or related experience in a highly regulated industry
• Demonstrated use of quality tools/methodologies
• Strong communication skills (verbal & written)
• Strong mechanical and electrical aptitude
• Ability to travel up to 10% (Domestic and International)

Preferred Qualifications

• Experience in design engineering or process development, including design optimization, process validation, and continuation engineering,
• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization
• Adaptable and effective collaborator in a team environment or in self-directed work
• Experience writing specifications, test protocols, and technical reports
• Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, 5 Why’s.
• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics
• Experience with mechanical and electrical test and measurement equipment

Maximum Salary: $ 132000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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