Boston Scientific Senior Design Quality Engineer 

United States, Minnesota 

10712243

About the role:

The Senior DQ Engineer will work cross-functionally to ensure safety, quality and compliance of the device while delivering the highest quality product to the customer. This role will serve as the Quality team lead on NPD, Sustaining, and/or Integration projects and will utilize quality engineering methodologies and practices which meet BSC, customer, and regulatory requirements.

This role offers a unique chance to gain end-to-end exposure to the full Product Life Cycle Process (PLCP) including design, development, integration, and sustaining of Medtech devices.

Your responsibilities will include:

• Function as Quality Core Team member on project teams to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Gathers and uses clinical knowledge to influence how devices they are working on are evaluated and designed
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
• Applies critical thinking and sound engineering analysis as part of systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Leads the implementation and development of product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs)
• Application of validation and statistical techniques to comply with associated regulatory requirements and internal standards and provide guidance to cross-functional team on the application of these techniques
• Champions the culture of quality-centric patient care and customer satisfaction within the Peripheral Interventions team
• Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines)
• Advise management on potential improvements or enhancement to quality systems and processes in the company, and own actions to implement said improvements

Required qualifications:

• BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience to perform at this level
• 5+ years’ experience in design quality or related quality field; or equivalent combination of education and experience to perform at this level
• 2+ years’ experience with MedTech device design and development
• Demonstrated use of Quality tools and methodologies with an emphasis on Design Controls and Risk Management
• Experience leading Design Quality projects
• Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability)
• Ability to travel up to 10%

Preferred qualifications:

• Demonstrated experience developing and launching catheter based medical devices
• Strong technical knowledge, problem-solving capabilities, collaborative mindset, and effective communication skills
• Comfortable working ‘in the gray;’ known for innovative, out of the box thinking to identify novel approaches to meeting requirements
• Experience with devices used in the treatment of carotid artery disease
• 1-2 years’ supervisory experience of technical personnel
• Working knowledge of human factors / usability engineering
• Six Sigma Black Belt

Maximum Salary: $ 156900

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.