Senior Process Engineer II - Sterilization

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SUMMARY

We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on sterilization processes in the medical device industry. The successful candidate will be responsible for partnering with sterilization Subject Matter Experts to interpret and translate requirements into compliant and harmonized systems and procedures. This role requires a strong process-engineering mindset, a willingness to learn about sterilization technologies (such as EO, steam, gamma radiation, etc.), an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The candidate must be a senior-level professional/team player with advanced process engineering knowledge and a propensity to lead successful teams. An understanding medical device sterilization processes, validation, and control is preferred. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

Team Leadership & Development:

• Lead, listen to, and manage a team of subject matter experts responsible for implementing and optimizing contamination 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

Sterilization Process Oversight:

• Translate SME knowledge to develop, implement, and monitor sterilization processes for medical devices to maintain the highest levels of product quality and safety.
• Ensure compliance with industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements.

Cross-Functional Collaboration:

• Work closely with R&D, manufacturing, quality assurance, and regulatory teams to ensure sterilization processes are integrated into the overall product development lifecycle. Provide technical guidance on sterilization-related concerns throughout the product lifecycle.

Risk Management & Safety:

• Ensure that sterilization programs are aligned with broader risk management processes in the company, addressing sterility-related risks and risks arising from the sterilization process from both a product and patient safety perspective.

Regulatory Compliance & Documentation:

• Ensure thorough documentation and records related to sterilization validations and processes, including process flow diagrams, standard operating procedures, and sterilization program management tools.

• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position

• 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.

Preferred Skills:

• Familiarity with sterilization processes including cycle design, validations, and maintenance of validated state.
• Strong understanding of product risk management processes.
• Experience creating and changing procedures for establishing, validating, and controlling critical processes within the medical device industry.
• Awareness of applicable sterilization standards including, but not limited to, ISO 11135, ISO 11137, ISO 11737, ISO 17665, ISO 11138, ISO 22441, and other applicable standards for medical device sterilization.

TOOLS AND EQUIPMENT USED

• Knowledge of Visio and other process improvement tools required.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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