Boston Scientific Design Quality Engineer III 

United States, Minnesota 

746718718

Your responsibilities will include:

• Ownership of design change projects including scoping, assessment, and implementation.
• Develop, update, and maintain Design History File and Design Input / Output documentation
• Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we're looking for in you:
Required qualifications:

• Bachelor’s degree in an engineering discipline
• Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
• Experience writing specifications, test protocols, and technical reports
• Demonstrated use of quality tools and methodologies include DFMEA, Hazard Analysis, Root Cause Analysis
• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics
• Strong communication skills (verbal and written). Effectively present complicated technical information to small and large audiences, from peers to senior leadership.

Preferred qualifications:

• Bachelor’s degree in mechanical, electrical, or biomedical engineering
• Experience with post-market quality, including returned product analysis and corrective and preventive action (CAPA)
• Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
• Experience in design engineering or process development, including design optimization, process validation, and sustaining engineering
• Adaptable and effective collaborator in a team environment and in self-directed work
  

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.