Sterilization Engineer
Listed on 2026-02-16
-
Engineering
Manufacturing Engineer, Medical Device Industry -
Manufacturing / Production
Manufacturing Engineer, Medical Device Industry
Job Title:
Sterilization Engineer / Manufacturing Engineer
Company: PDV Med Tech
Industry: Medical Devices / Healthcare
About Us:
At PDV Med Tech, we are committed to delivering high-quality medical devices that enhance patient care and safety. As a rapidly growing leader in the medical device sector, we’re looking for a skilled Sterilization Engineer / Manufacturing Engineer to join our Lehi, Utah team. This role offers the opportunity to work on advanced sterilization technologies while supporting the full spectrum of medical device manufacturing, from assembly and injection molding to packaging and new product introduction.
Position Overview:
We are looking for a dynamic and experienced Sterilization Engineer / Manufacturing Engineer to play a key role in ensuring the sterilization processes for medical devices meet industry standards while providing critical support to the manufacturing operations. The ideal candidate will have expertise in sterilization technologies, including but not limited to ethylene oxide (EO) or chlorine dioxide, and experience working in medical device manufacturing, including assembly, injection molding, packaging, and new product introductions (NPI).
Key Responsibilities:
- Develop and validate sterilization processes for medical devices, ensuring compliance with FDA, ISO, and other regulatory requirements.
- Support the implementation and optimization of sterilization methods such as ethylene oxide, gamma, steam, and hydrogen peroxide, ensuring the highest standards of safety and effectiveness.
- Troubleshoot sterilization-related issues in the manufacturing process and implement corrective actions as needed.
- Work with cross-functional teams (R&D, QA, Manufacturing) to ensure that sterilization requirements are met during the product design and development phases.
- Maintain and update sterilization validation documentation, ensuring compliance with industry regulations and standards.
Manufacturing Engineering Support:
- Provide engineering support for medical device manufacturing processes, including assembly, injection molding, and packaging.
- Collaborate with the manufacturing team to optimize production processes for efficiency, cost-effectiveness, and quality.
- Lead initiatives to improve manufacturing processes, addressing issues related to production yield, cycle times, and product quality.
- Assist in the design, qualification, and scaling of new manufacturing equipment and tooling, particularly in injection molding and assembly lines.
- Support New Product Introduction (NPI) by helping integrate sterilization and manufacturing requirements into the product development lifecycle.
Process Improvement & Optimization:
- Continuously analyze and improve sterilization and manufacturing processes to ensure maximum efficiency, reliability, and cost-effectiveness.
- Drive continuous improvement initiatives through the implementation of Lean Manufacturing, Six Sigma, and other process optimization methodologies.
- Work closely with quality control and regulatory teams to ensure compliance with all safety, regulatory, and operational standards.
Documentation & Compliance:
- Ensure the proper documentation for sterilization process validation and manufacturing procedures, including test reports, qualification protocols, and regulatory submissions.
- Participate in internal and external audits related to sterilization, manufacturing processes, and compliance.
- Ensure that all manufacturing and sterilization processes adhere to ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
Cross-Functional Collaboration:
- Collaborate with R&D, quality, regulatory, and production teams to troubleshoot and resolve issues, implement improvements, and ensure the successful launch of new products.
- Support production teams by providing technical expertise during product assembly, molding, and packaging stages.
Qualifications:
Education:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related field. A Master’s degree is a plus.
Experience:
- Minimum of 5 years of experience in sterilization engineering within the medical device or healthcare industry.
- Experience in manufacturing…
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