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SUMMARY

We are seeking a highly skilled and motivated Senior Process Engineer II a focus on manufacturing contamination control in the medical device industry. The successful candidate will be responsible for partnering with microbiology 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 contamination control and controlled manufacturing environments, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. This role is critical to ensuring the integrity, safety, and compliance of our manufacturing processes, particularly in cleanroom environments, where stringent contamination control practices are essential to product quality. The candidate must be a senior-level professional/team player with advanced process engineering knowledge and a propensity to lead successful teams. An understanding of clean room practice/cGMP and laboratory/GLP environments 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 

Contamination Control Process Oversight:

• Translate SME knowledge to develop, implement, and monitor contamination control processes and strategies to maintain the highest levels of product quality and safety in manufacturing environments, including cleanrooms.

• Ensure compliance with industry standards such as ISO 14644, EN17141, ISO 13485, FDA regulations, and other relevant guidelines governing contamination control in medical device manufacturing.

Cross-Functional Collaboration:

• Collaborate closely with cross-functional teams (e.g., quality assurance, regulatory affairs, R&D, production) to ensure contamination control practices are integrated into product design and manufacturing processes.

Risk Management & Safety:

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

Regulatory Compliance & Documentation:

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

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

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 contamination control processes, including microbial contamination, cleanroom protocols, controlled environment monitoring, water system monitoring, compressed air monitoring, and bioburden testing.

• Experience creating and changing procedures used in operations for testing of the environment and products.

• Awareness of ISO 14644, ISO 13485, FDA regulations, and other relevant guidelines/standards governing contamination control in medical device manufacturing.

TOOLS AND EQUIPMENT USED

• Knowledge of Visio and other process improvement tools required.