Staff Quality Engineer – Design & Reliability Assurance

Integra LifeSciences

Staff Design Quality Assurance Engineer at Integra LifeSciences ensuring product quality in healthcare technology development. Interfacing with cross-functional teams and leading risk management processes.

Posted 6/19/2026full-timePrinceton • Illinois, Maryland, Massachusetts, New Jersey • 🇺🇸 United StatesLead💰 $109,250 - $149,500 per yearWebsite

About the role

Key responsibilities & impact

Work independently within broad guidelines, policies and the operational plan to impact a range of customer, operational, project or service activities within own team and other related teams
Manage complex processes, lead the work of small project teams, Formally train and act as a resource for colleagues with less experience
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
8+ years of experience in Quality Engineering, process engineering or R&D Engineering for medical device, with at least 3 years of direct DQA experience
Expert 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
Expert knowledge and understanding of applicable national and international regulations and standards
Excellent organizational, verbal and written communication skills
Expert with the MS Office Suite, and statistical software
Must be able to work independently with minimal supervision, guide and coach more junior colleagues
Able to prioritize projects and manage time to meet organizational goals and objectives
Experience presenting to External Regulatory Agency in 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

Quality Engineeringprocess engineeringR&D Engineeringrisk managementdesign controlstatistical samplingdata analysisdesign verificationdesign validationprocess validation

Soft Skills

organizational skillsverbal communicationwritten communicationindependent workcoachingtime managementproject prioritization

Certifications

Bachelor’s degree in ScienceBachelor’s degree in EngineeringISO CertificationFDA compliance