Senior Quality Engineer, Design Assurance

Integra LifeSciences

Design Quality Assurance Engineer responsible for NPD and compliance in medical device industry. Supporting design processes and coordinating with cross-functional teams for quality assurance in healthcare.

Posted 6/19/2026full-timePrinceton • Illinois, Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $81,650 - $112,700 per yearWebsite

About the role

Key responsibilities & impact

Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs
Support Design Reviews, Technical Reviews, and Gate Reviews
Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs
Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA)
Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution
Coordinate, review and approve development documentation created by external partners
Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer
Maintains knowledge of and applies statistical analysis to support data-driven decision making
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary
Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert
Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects
Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
Identify and implement opportunities for continuous improvement in the quality system
Interact and coordinate activities with other departments, external vendors, and customers
Perform other Quality Systems related duties as required

Requirements

What you’ll need

Bachelor’s degree in Science, Engineering (Biomedical, Mechanical or Electrical) or related discipline
4+ years of experience in Quality Engineering, process engineering or R&D Engineering for medical device
Proficient in the application of risk management and design control standards and best practices to NPD and LSM
Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
Demonstrated knowledge and understanding of applicable national and international regulations and standards
Demonstrates excellent organizational, verbal and written communication skills
Proficient with the MS Office Suite, and statistical software
Must be able to work independently with minimal supervision
Able to prioritize projects and manage time to meet organizational goals and objectives
Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA)
Knowledge of TrackWise preferred
Knowledge of Agile product lifecycle management system preferred

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
savings plan (401(k))

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Risk ManagementUsability EngineeringFMEAStatistical AnalysisDesign VerificationProcess ValidationQuality System ProceduresStatistical SamplingDesign Control StandardsNPD

Soft Skills

Organizational SkillsVerbal CommunicationWritten CommunicationTime ManagementIndependent WorkCollaborationContinuous Improvement

Certifications

ISO CertificationGMP ComplianceQSR Compliance