Process Engineer I/II Extrusion

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Position Description The Process Engineer I/II plays a critical role in supporting manufacturing operations by delivering hands-on, solution-oriented engineering support across extrusion processes. This role contributes directly to operational efficiency, product quality, and team member experience by troubleshooting production challenges, optimizing processes, and ensuring consistent execution on the manufacturing floor. The Process Engineer partners closely with operators, technicians, and cross-functional teams to identify root causes, implement improvements, and maintain compliant, well-documented processes. Key Responsibilities Troubleshoot extrusion production lines and secondary operations to identify and resolve process-related issues. Analyze manufacturing data to identify trends, root causes, and opportunities for process improvement. Support and execute process validation activities, including Installation Qualification, Operational Qualification, Performance Qualification (IQ/OQ/PQ) documentation and reporting. Develop and maintain technical documentation such as standard operating procedures (SOPs), work instructions, process specifications, and troubleshooting reports. Collaborate closely with operators and technicians to understand real-time production challenges and implement effective solutions. Spend time both on the manufacturing floor and at a workstation to support hands-on problem solving and documentation. Support new and existing product builds by ensuring processes are stable, repeatable, and efficient. Utilize statistical tools to support data-driven decision making. Ensure adherence to company policies, quality standards, and regulatory requirements. Contribute ideas for continuous improvement that enhance efficiency, quality, and team member experience. Success in This Role Looks Like Production issues are identified and resolved quickly with clear root cause analysis (RCA). Processes become more stable, efficient, and repeatable over time. Operators and team members feel supported through clear communication and hands-on partnership. Technical documentation is accurate, complete, and supports compliance requirements. The engineer builds strong knowledge of extrusion processes and production flow. The engineer begins taking ownership of individual projects and driving them to completion. Position Requirements This Position Requires the Following Skills and Attributes Bachelor's degree in Mechanical, Manufacturing, Materials, Biomedical Engineering, or related field. More than one year of relevant experience Demonstrate strong problem-solving and critical thinking skills, with the ability to break down complex issues and identify root causes. Comfort working in a hands-on manufacturing environment and engaging directly on the production floor. Communicate clearly and effectively with both technical and non-technical team members. Apply strong organizational skills to manage multiple priorities in a fast-paced environment. Demonstrate attention to detail in both troubleshooting and documentation. Show willingness to learn and adapt to new processes, equipment, and technologies. Maintain a high level of accountability, ownership, and follow-through. Preferred The Following Skills and Attributes are Preferred Experience supporting extrusion or similar manufacturing processes. Technical writing proficiency, including

IQ/OQ/PQ

documentation, SOPs, validation protocols, technical reports). Familiarity with statistical analysis tools, such as Minitab. Working knowledge of Geometric Dimensioning and Tolerancing (GD&T). Experience in a regulated industry such as medical devices or similar.

Benefits Competitive compensation range:

$71,000 - $95,000 / year (California). Comprehensive benefits package. Training and mentorship opportunities. On-campus wellness activities. Education reimbursement program. 401(k) program with discretionary employer match. Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply. Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. Equal Opportunity Employer Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.

Qualifications:

This Position Requires the Following Skills and Attributes Bachelor s degree in Mechanical, Manufacturing, Materials, Biomedical Engineering, or related field. More than one year of relevant experience Demonstrate strong problem-solving and critical thinking skills, with the ability to break down complex issues and identify root causes. Comfort working in a hands-on manufacturing environment and engaging directly on the production floor. Communicate clearly and effectively with both technical and non-technical team members. Apply strong organizational skills to manage multiple priorities in a fast-paced environment. Demonstrate attention to detail in both troubleshooting and documentation. Show willingness to learn and adapt to new processes, equipment, and technologies. Maintain a high level of accountability, ownership, and follow-through.