Boston Scientific Senior Design Quality Engineer - Peripheral Interventions 

United States, Minnesota 

646989414

Your responsibilities include:

• Representing the voice of quality as a Core Team member on product development team to ensure that design implementation meets the intent of product design while meeting quality standards and strategic business objectives.
• Develop and maintain understanding of the product/therapy space, including clinical use applications, to effectively integrate this knowledge with functional quality management system requirements.
• Application of Design Control and Risk Management processes throughout product development lifecycle, independently or as a member of a team. Provide quality and compliance input to colleagues for project decisions and deliverables.
• Creation, execution, and documentation of System Design Validation & Verification activities such as protocols, test cases, reports, investigation and resolution of issues identified during test.
• Collaborate with cross-functional design team to support creation and documentation of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis, and Software Design Failure Mode and Effects and Analysis
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Provides quality input as a subject matter expert and or independent reviewer. Support internal and external regulatory audits as required.
• Advise management on potential improvements or enhancements to quality systems, processes, and products in the company.

What we’re looking for in you:
Required Qualifications:

• Bachelor’s degree in engineering, physics, math, or other science discipline, or equivalent.
• Minimum of 4 years experience in design quality, system test, systems R&D, or product development engineering in Medtech /regulated industry experience; or equivalent combination of education and experience
• Understanding and demonstrated use of industry standards (e.g. IEC 60601, IEC 62304). within product design and development process
• Strong ability to navigate ambiguous situations in a collaborative, innovative, and people-centric team environment.
• Knowledge of key regulatory requirements including of ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR.
• Travel approximately <10%

Preferred Qualifications:

• Experience in Complex Systems Development or Integration Engineering
• Variable and Attribute Test method generation and validation experience
• Prior exposure to risk management tools & methodologies such as hazard analysis, FMEA on detailed work with emphasis on accuracy and completeness
• Ability to collaborate and work on a highly matrixed and global team
• Experience with Class III Medical Devices
  

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.