Position Details

Type Full-Time

Experience senior

Exp. Years 7+ years

Education Bachelor of Science in Engineering or related technical field

Category Engineering (Non-Software)

About this role

Senior Design Assurance Engineer leads design assurance activities for medical devices within Boston Scientific, focusing on risk management, design controls, and regulatory compliance across product development and lifecycle.

Key Responsibilities

Lead advanced, systematic problem-solving to resolve product/process quality issues
Provide senior quality engineering leadership on NPD teams
Drive risk management activities (hazard analysis, FMEAs)
Develop/approve verification and validation protocols and reports
Establish and maintain Design History File documentation

Technical Overview

Expertise in ISO 13485 and ISO 14971; risk management, hazard analysis, FMEAs, design verification and validation; Design History File management; cross-functional collaboration with R&D and manufacturing.

Ideal Candidate

The ideal candidate is a senior-level design assurance engineer with 7+ years in medical device quality, strong ISO13485/14971 experience, and proven cross-functional leadership in R&D, manufacturing, and regulatory domains.

Must-Have Skills

Bachelor of Science degree in Engineering or related technical fieldMinimum of 7 years' experience in quality engineering or design assurance in medical devicesRisk managementdesign controls and product verification and validationISO 13485 and ISO 14971 knowledgeAbility to lead cross-functional initiatives

Nice-to-Have Skills

Biomedical or mechanical engineering degreeExperience with cardiovascular implantable medical devicesCQE certificationAdvanced quality tools and statisticsTalent development and building high-performing teams

Required Skills

Bachelor of Science in Engineering; 7+ years medical device quality engineering; risk management; design controls; FMEAs; ISO 13485; ISO 14971; cross-functional leadership; V&V; Design History File; regulatory compliance

Hard Skills

design assurancerisk managementFMEAsISO 13485ISO 14971verification and validationDesign History Filedesign controlsregulatory compliancecross-functional leadershipstatistical methods

Soft Skills

leadershipcommunicationproblem solvingability to navigate ambiguitycollaboration

Certifications

Preferred

Certified Quality Engineer (CQE)

Industry & Role

Industry Healthcare & Medical

Job Function Lead design assurance activities to ensure patient safety and regulatory compliance for medical devices.

Role Subtype Quality Assurance

Tech Domains Design History File, ISO 13485, ISO 14971, FMEAs, Verification and Validation, Quality Engineering

Keywords for Your Resume

Senior Design Assurance EngineerBoston Scientificmedical deviceISO 13485ISO 14971risk managementhazard analysisFMEAsverification and validationDesign History Filedesign controlsV&Vregulatory compliancecross-functionalR&DmanufacturingclinicalCQECertified Quality Engineersenior design assurance engineercross-functional leadership

Deal Breakers

Bachelor's degree in engineering, 7+ years in medical device quality engineering, Experience with risk management, design controls, V&V

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