Boston Scientific Design Quality Engineer III 

United States, Minnesota, Minnetonka 

685263923

About the role:

This position will start off at our Minnetonka, MN facility but will be transferred to our Maple Grove, MN facility in 2026.

Your responsibilities will include:

• Support the execution and documentation of Design Validation & Verification and Usability activities
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Lead and support cross-functional root-cause analysis investigation and resolution activities.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Support regulatory submissions to notified bodies.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure.

What we're looking for in you:

Required qualifications:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related field
• 4+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Demonstrated use of tools/methodologies supporting Quality Engineering discipline including CAPA, risk management, design controls, problem solving, and data analysis.
• Understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
• High energy problem solver capable of driving items to closure.
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
  

Preferred qualifications:

• Experience with pharmaceutical or combination medical devices.

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.