Integra LifeSciences · 3 hours ago
Staff Design & Reliability Assurance Quality Engineer
Mansfield, MA
Full-time
Onsite
Senior Level, Lead/Staff
$109K/yr - $150K/yr
8+ years expIntegra LifeSciences is a company dedicated to creating change and advancing patient outcomes in healthcare. They are seeking a Staff Design & Reliability Assurance Quality Engineer to lead risk management activities and collaborate with cross-functional teams on various projects, including New Product Development and Continuous Improvement initiatives.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Hiring Manager
Kurt Dooley
Responsibilities
Provide Risk Management and Human Factors leadership, expertise, guidance and supervision during all project phases from initiation through end of life
Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management
Leads development and implementation of key performance indicators (KPI’s) and metrics for the risk management process and metrics
Leads and conducts SWAT assessments in risk management to support continuous improvement across business processes
Lead the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams
Lead and support New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity
Collaborates with internal customers and external design and development partners, participating on cross-functional project teams through all phases of the product and process development through commercialization, and supports technical teams with planning, execution, reporting and communication of Design and Reliability Assurance work products and deliverables
Qualification
Required
Bachelor's degree in engineering (Mechanical, Systems, Chemical or Electrical) or Science (Biology, Chemistry)
8 years of experience of working within a Medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP
Strong analytical skills and a working knowledge of problem-solving methodologies
Working knowledge of DFSS techniques
8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development
Fluent in French and English
Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology
Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
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 assigned Design Assurance resources to meet organizational goals and objectives
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Medical Product Outsourcing
2025-11-13
Company data provided by crunchbase