Boston Scientific Senior Design Assurance Engineer 

United States, Minnesota 

303009178

Spencer Gregory Hale

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.
• Learn differences in divisional Quality Systems and Tools and apply them to product development or to design change process.
• 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 for cross divisional product.
• 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.

Minimum 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 electrical, software, or systems engineering.
• Experience in design engineering or process development, including design optimization, 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.

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.