Boston Scientific Senior Design Assurance Engineer 

United States, Minnesota 

307989033

Your responsibilities will include:

• Understanding and application of design engineering concepts and tools including Design Failure Modes and Effects Analysis (DFMEA), Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Serve as an effective quality leader or team member on a cross-functional product development team.
• Owns and drives deliverables related to Design Controls, Product Performance, Quality, and Compliance.
• Develops and implements quality strategies; seeks innovative approaches to attain quality goals.
• Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports.
• Maintains and enhances cross-functional team relationships.
• Directly interfaces with internal and external audit activities.

What we're looking for in you:

Required Qualifications

• Bachelor’s degree in engineering (or other related technical discipline).
• 5+ years of experience in design assurance, post-market quality, or R&D engineering.
• Strong mechanical and electrical aptitude.
• Experience writing specifications, test protocols, and technical reports.
• Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why’s.
• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics.
• Experience with mechanical and electrical test and measurement equipment.
• Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.
• Proficient use of Microsoft Teams, Word, PowerPoint, and Excel

Preferred Qualifications:

• Bachelor’s degree in mechanical engineering.
• Experience in design engineering or process development, including test method validation, process validation, and continuation engineering.
• Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA).
• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
• Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
• Adaptable and effective collaborator in a team environment or in self-directed work.
  

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.