Senior Design Assurance Engineer

Recruiter: Spencer Gregory Hale

Senior Design Assurance Engineer

About the role:

The Senior Design Assurance Engineer directly supports medical device product development from concept through commercialization.This engineer will serve as a quality representative on a high-performing cross-functional and cross-divisional team for product transfer and development on a major product category. This high visibility position provides the right candidate with excellent growth and development potential.

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

Requisition ID:599467

Minimum Salary:$82600

Maximum Salary: $156900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest 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.