Integra LifeSciences · 2 weeks ago
Senior Process Engineer II - Endotoxin
Princeton, NJ
Full-time
Onsite
Mid, Senior Level
$94K/yr - $130K/yr
5+ years expIntegra LifeSciences is dedicated to creating change in healthcare by innovating new treatment pathways. They are seeking a Senior Process Engineer II to lead bacterial endotoxin testing programs in the medical device industry, ensuring compliance and product safety through effective team management and collaboration with cross-functional teams.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead, listen to, and manage a team of subject matter experts responsible for implementing and optimizing bacterial endotoxin control programs in medical device manufacturing
Foster a collaborative environment by promoting knowledge sharing, training, and professional growth within the team
Manage team performance and set clear objectives to ensure that all goals are met efficiently and in compliance with industry standards
Support the Environmental Controls Senior Manager with providing direction to the team, coordinating workflow, and providing guidance in the resolution of problems or areas of concern
Translate SME knowledge to manage the development, implementation, and validation of bacterial endotoxin control programs, ensuring compliance with relevant regulatory requirements such as ANSI/AAMI ST72, ISO 11737-3, USP , USP , and FDA guidelines.- Ensure proper integration of endotoxin testing within the overall product lifecycle, from early-stage development through manufacturing, packaging, and final product release
Work closely with quality assurance and production teams to integrate endotoxin control practices within broader quality systems and manufacturing processes
Collaborate with the sterilization and contamination control teams to ensure endotoxin levels are considered and controlled throughout the product lifecycle
Lead risk assessments related to endotoxin control, identifying potential sources of contamination and implementing strategies to mitigate risks
Ensure that endotoxin testing and control programs are aligned with broader risk management processes in the company, addressing endotoxin-related risks from both a product and patient safety perspective
Ensure thorough documentation and records related to contamination control, including process flow diagrams, standard operating procedures, and endotoxin program management tools
Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements
Qualification
Required
Bachelor degree with 8+ years of experience or equivalent education and years of experience
Master degree with 5+ years of experience or equivalent education and years of experience
Doctoral degree with 3+ years of experience or equivalent education and years of experience
Bachelor's or Master of Science degree in Industrial Engineering, Biomedical Engineering or similar discipline
Minimum of 3-5 years of experience in process engineering
Demonstrates excellent leadership and organizational skills
Excellent process mapping skills with an understanding of good documentation practice
Strong written and verbal communication skills
Proven ability to lead a team, manage multiple projects, and work cross-functionally
Detail-oriented with a commitment to maintaining high-quality standards and regulatory compliance
Experience with quality management systems (QMS) and CAPA processes
Strong process-engineering mindset
Understanding of medical device quality systems
Commitment to ensuring product safety and compliance
Understanding of bacterial endotoxin testing programs
Understanding the concepts of risk management as it relates to bacterial endotoxin monitoring in a medical device manufacturing environment
Preferred
Familiarity with bacterial endotoxin control methods, including LAL (Limulus Amebocyte Lysate) testing, recombinant Factor C assay, and endotoxin limit specifications
Experience creating and changing procedures used in operations for testing of the environment and products
Awareness of applicable endotoxin standards including, but not limited to, ANSI/AAMI ST72, ISO 11737-1, USP , USP , and FDA guidelines
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
Company data provided by crunchbase