Design Quality Engineer II

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:
Boston Scientific is currently recruiting for a Design Quality Engineer II in our Maple Grove, MN location.  This is an exciting opportunity to participate in the quality assurance of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.     
 
The Design Quality Engineer II will support the application of design controls to focusing on new product development and sustaining engineering projects. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.

Your responsibilities will include:

• Works within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Update and maintain risk management files, such as Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Apply judgement to solve problems and determine appropriate action and solutions
• Supports departmental, functional, and divisional design quality goals and priorities.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements

What we're looking for in you:
Required qualifications:

• Bachelor’s degree in an engineering discipline 
• Minimum 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
• Knowledge of basic Quality System Requirements and Good Documentation Practices
• Experience writing specifications, test protocols, and technical reports
• Strong communication skills (verbal and written). Effectively organize, present, and explain information to internal audiences.

Preferred qualifications:

• Bachelor’s degree in mechanical, electrical, chemical, or biomedical engineering
• Demonstrated use of quality tools and methodologies including DFMEA, Hazard Analysis, Root Cause Analysis, CAPA
• Demonstrated ability to solve engineering problems using analysis, experimentation, and statistics
• Experience with medical device 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 and in self-directed work

 

 

 

Requisition ID: 614123 

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.

 

As a leader in medical science for more than 40 years, we are committed to solving the chall