Design Quality Engineer III

Additional Location(s):Canada-ON-Mississauga; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MA-Waltham; US-MN-Maple Grove

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.

This position will work on EP/CRM Integration projects, specifically supporting Design Controls under the direction of the Design Control Workstream lead. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with regulatory requirements. The Design Quality Engineer III directly supports medical device product development from concept through commercialization.

This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Candidates can be based out of the following locations:
Arden Hills, Maple Grove, Valencia, Waltham, Marlborough, Spencer, or Mississsauga

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

This role will not provide relocation support or assistance.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member and mentor in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
• Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross-functionally to identify and support value improvement efforts to support business goals

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
• Minimum of 3 years of experience in Quality design assurance, new product development or related medical device/regulated industry experience
• Ability to travel up to 10%

• Quality Integration experience
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Boston Scientific experience
• Proven ability to influence without authority
• Ability to effectively work and collaborate in a mixed onsite + remote environment.

Requisition

Minimum Salary: $ 78,300

Maximum Salary: $ 148,800

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…