Boston Scientific Design Quality Engineer III 

United States, Minnesota 

169316220

We have an exciting opportunity for Design Quality Engineer III supporting WATCHMAN projects within the BSC’s Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. In a hybrid work mode, the Design Quality Engineer III supports a major product category with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The engineer will provide quality engineering support to operations, product development and sustaining projects for current products on the market. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Design Quality Engineer III will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities and will provide quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.
Your responsibilities 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 in you:
Required Qualifications:

• Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent.
• Minimum of 3 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.
• ISO 13485, ISO 14971, and Quality System Regulations understanding
• Strong communication skills (verbal & written) and presentation skills

Preferred Qualifications:

• Focus on detailed work with emphasis on accuracy and completeness
• Excellent organizational and planning skills; drives for results
• High energy problem solver capable of driving items to closure
• Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.

Maximum Salary: $ 144400

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.