Boston Scientific Senior Design Quality Engineer 

United States, Minnesota 

607849349

Your responsibilities will include

• Execution & strategy of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR
• Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate
• Develops solutions to technical problems. Investigate failure modes, perform root cause analyses, and develop solutions to address technical challenges. Ensure compliance with relevant regulatory requirements and standards
• Execute cross-functional plans, provide feedback to overall project strategy, knows when to solicit feedback, and facilitate project decisions to ensure successful product development and integration
• Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work, as well as support internal & external regulatory audits
• Author and review design documentation, including technical reports, design history files, design verification protocols/reports and regulatory submissions. Present project updates and technical insights to stakeholders.

What we're looking for in you
Required qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical, chemical engineering, or related discipline
• 4+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
• Experience with Risk Management Standard ISO 14971
• Experience with class III medical devices
• Experience with reliability testing
• Demonstrated use of Quality tools/methodologies
• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills

Preferred qualifications:

• An independent critical thinker; willingness to challenge status quo
• Understanding of electrical safety standards IEC 60601
• Previous experience with product integrations
• Strong knowledge of QSR and ISO standards
  

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.