Boston Scientific Quality Design Engineer II 

United States, Minnesota 

71064961

Spencer Gregory Hale

About the role:

The Design Assurance Engineer II is a quality engineer that will support commercialized products within the structural heart valves division to improve the delivery of care for customers and patients around the world. This role will work within high-performance, cross-functional teams by providing quality engineering support to design requirements, product verification and validation, risk management, design change control, and ongoing product design activities.

Your responsibilities will include:

• Apply sound, systematic problem-solving methodologies to resolve quality issues
• Actively promote and participate in a cross-functional teamwork environment
• Support the implementation and lifecycle management of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
• Generate protocols and reports to support verification and validation activities
• Establish and maintain Design History File and Design Input / Output documentation (Design Requirements, Component Specifications, and Prints)
• Monitor field performance of recently-launched and established medical devices against risk assessments

Required qualifications:

• Bachelor of Science degree in Engineering or related fields
• 2-4+ years of experience in design assurance, sustaining engineering, or related medical device experience
• Strong communication skills (verbal & written)
• Comfortable working independently and as part of a cross-functional team
• Ability to manage multiple priorities and work with ambiguity

Preferred qualifications:

• Degree in Biomedical or Mechanical Engineering
• Knowledge of ISO 13485, ISO 14971, and Quality System Regulations
• Demonstrated use of Quality tools/methodologies
• Self-motivated with a passion for solving problems and a bias for action

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.