Process Engineer I/II – Extrusion

Applied Medical

Posted 2 months ago

Full Time

Rancho Santa Margarita, California

In Person

Smart Summary

Responsibilities

The Process Engineer will provide hands-on engineering support for extrusion production lines, including troubleshooting, process optimization, and root cause analysis. They will also manage technical documentation, support process validation activities, and collaborate with cross-functional teams to ensure manufacturing efficiency and quality.

Qualifications

The Process Engineer I/II role requires a Bachelor's degree in a relevant engineering field and over one year of experience. Key responsibilities include troubleshooting extrusion production issues, analyzing data for process improvements, and developing technical documentation. Strong problem-solving, communication, and hands-on manufacturing environment skills are essential.

Job Description

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. 

Applied Medical

As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice. Our vertically integrated programs in design, development, manufacturing, and distribution enable us to consistently meet these objectives. As a vertically integrated company, we manufacture all of our products in-house at our corporate headquarters in Rancho Santa Margarita, California, and our European headquarters in Amersfoort, Netherlands with distribution centers around the world. Applied manufactures surgical devices for a wide range of medical specialties. Each year, Applied dedicates, on average, 20% of our revenue to product development and projects that increase the efficiency of our manufacturing operations. As such, we are able to fuel the continuous development of new surgical technologies. Applied is proud to have a significant and sustainable impact on healthcare. We address patient needs with advanced technologies that enhance surgical outcomes while also meeting our customers’ pressing economic needs. Applied team members are part of one of the fastest growing and most progressive organizations in the healthcare field. We are proud to have a culture strongly committed to ethical business practices, mutual respect, teamwork, and caring about our customers and our community. Applied's team members come from a wide range of experience, and their perspectives are crucial to the continued success of our organization. Applied respects each team member’s opinion and fosters a culture of open communication across all levels and departments. We are looking for exceptional people who share in our mission to deliver breakthrough technologies that enhance surgical and clinical care. We seek creative problem-solvers from a variety of career paths and backgrounds who are interested in making a meaningful, positive difference. https://appliedmedical.com/Legal/SocialMedia
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