Quality Design Engineer II

Recruiter: Spencer Gregory Hale

Design Assurance Engineer II

About the role:

Apply your skills and experience to ensure patient safety by joining the Design Assurance team at Boston Scientific. Thrive in a culture that prioritizes learning and development, builds lasting relationships with colleagues, and truly makes a difference to patients.

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

Requisition ID: 602256 

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 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.