Manufacturing Engineer I/II – Extrusion

Applied Medical Corporation; Rancho Santa Margarita (CA); On-site; USD 71,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Mentorship opportunities

On-campus wellness activities

Education reimbursement

Job summary

Applied Medical Corporation is a new-generation medical device company with a proven business model and commitment to innovation. The Manufacturing Engineer I/II - Extrusion is a hands-on role on the production floor, focused on troubleshooting, optimizing extrusion processes, and partnering with operators to improve safety, quality, throughput, and scrap performance.

This position spends significant time in manufacturing, collaborating with Production, Maintenance, Quality, and technicians to

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Industrial Engineering or related field.
• Strong problem-solving and critical thinking skills with ability to break down complex issues.
• Hands-on manufacturing environment experience and ability to engage on the production floor.
• Clear communication with technical and non-technical teammates.
• Organizational skills to manage multiple priorities in a fast-paced setting.

Responsibilities

• Troubleshoot extrusion equipment, production lines, and secondary operations to resolve issues and improve uptime.
• Optimize extrusion processes, equipment performance, and process stability for quality and throughput.
• Support tooling, machine setups, changeovers, and capital projects.
• Investigate causes of variation, downtime, and scrap using root cause analysis and data-driven methods.
• Partner with Production, Maintenance, Quality, operators, and technicians to implement sustainable solutions.
• Assist new and existing product introductions by developing stable, repeatable processes.
• Develop and maintain SOPs, work instructions, process specs, validation protocols, and troubleshooting reports.
• Execute IQ/OQ/PQ validation protocols and reporting as required.
• Use statistical tools and manufacturing data to identify trends and drive improvements.
• Ensure compliance with quality standards and regulatory requirements.

Skills

Root cause analysis

Hands-on troubleshooting

Cross-functional collaboration

Data-driven problem solving

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial Eng

Tools

Minitab

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 earneda strong reputationfor 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 Manufacturing Engineer I/II - Extrusion is a highly hands-on manufacturing engineering role focused on troubleshooting equipment, optimizing extrusion processes, and partnering directly with operators on the production floor. This position spends significant time in manufacturing, driving real-time solutions to production challenges and improving safety, quality, throughout, and scrap performance.

Key Responsibilities

• Troubleshoot extrusion equipment, production lines, and secondary operations to resolve manufacturing issues and improve uptime.
• Optimize extrusion processes, equipment performance, and process stability to improve quality, throughput, and efficiency.
• Support tooling, machine setups, changeovers, equipment improvements, and capital projects.
• Investigate mechanical and process-related causes of variation, downtime, and scrap using root cause analysis and data-driven problem solving.
• Partner closely with Production, Maintenance, Quality, operators, and technicians to implement sustainable solutions.
• Support new and existing product introductions by developing stable, repeatable, and efficient manufacturing processes.
• Develop and maintain technical documentation, including SOPs, work instructions, process specifications, validation protocols, and troubleshooting reports.
• Execute process validation activities, including IQ/OQ/PQ protocols and reporting, as required.
• Utilize statistical tools and manufacturing data to identify trends and drive continuous improvement initiatives.
• Ensure compliance with quality standards, regulatory requirements, and company policies.

Success in This Role Looks Like:

• Extrusion equipment operates reliably with improved uptime, reduced downtime, and fewer process interruptions.
• Manufacturing processes become more stable, efficient, and repeatable, resulting in improved quality and reduced scrap.
• Production issues are resolved quickly through effective troubleshooting and root cause analysis.
• Operators, technicians, and cross-functional teams view the engineer as a trusted, hands-on partner on the manufacturing floor.
• Equipment improvements, process changes, and capital projects are successfully implemented and deliver measurable results.
• Technical documentation and validation activities are completed accurately and support compliance requirements.
• The engineer develops strong expertise in extrusion equipment, polymer processing, and manufacturing operations.
• Individual improvement projects are owned from identification through implementation and sustained results.

Position Requirements

This Position Requires the Following Skills and Attributes

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, Industrial Engineering, Materials Engineering, or related discipline. Candidates with direct manufacturing or extrusion experience are strongly preferred.
• 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.