Design Quality Assurance Engineer II

Recruiter: Spencer Gregory Hale

Design Quality Assurance Engineer II

About the role:

The Design Quality Assurance Engineer II is a quality engineer who will directly support commercialized medical device design changes.This engineer will work with a high-performing cross-functional team to ensure safety, quality, and compliance of the launched products while continuously improving their commercial value. This high visibility position in the WATCHMAN division provides the right candidate with excellent growth potential.

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

Requisition ID:598311

Minimum Salary:$69500

Maximum Salary: $132000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest 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.