Design Quality Engineer II

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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:

This Design Quality Engineer II will provide support with the WATCHMAN products within the Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth  this position you will work with a cross-functional team to support medical device product development from development through commercialization and ensure the safety, quality and compliance of launched products by establishing and maintaining the design control deliverables and risk management activities.

Your responsibilities will include:

• Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
• Support regulatory submissions to notified bodies.
• Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
• Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team

What we’re looking for:
Required Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
• 2 years of experience in design assurance, quality, or related medical device or regulated industry experience
• Self-motivated with a passion for solving problems and a bias for action
• Hands-on approach to problem solving
• Ability to effectively work and collaborate in an office/remote environment
• Adaptable and effective collaborator in a team environment or in self-directed work

Requisition

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  --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 challenges that matter most – united by a deep caring…