Plastics Process Engineer, Mission Viejo

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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:
Join Applied Medical and contribute to advancing the future of medical device manufacturing. As a Plastics Process Engineer, you will play a hands-on role in developing, optimizing, and supporting manufacturing processes with a strong focus on injection molding, heat treating, and complex part fabrication. This position offers a dynamic environment where engineers are deeply involved in the production floor and collaborate closely with cross-functional teams, operators, and technicians to make a direct impact on patient care.

 

Key Responsibilities:

Process Optimization and Improvement: Analyze, improve, and sustain injection molding and sintering or heat treating processes. Troubleshoot issues on the production floor to reduce scrap, increase uptime, and improve process capability. Create and document process recipes, including equipment settings, materials, and parameters. Apply SPC techniques, including control charts, variation analysis, and Six Sigma tools to drive process control. 

Equipment and Tooling:Collaborate with tooling and mold design teams to develop and optimize molds and fixtures. Support the setup, qualification (IQ/OQ/PQ), and preventive maintenance of injection molding machines, furnaces, and supporting equipment. Investigate new technologies and materials to improve product quality and process reliability.

Quality and Compliance: Ensure manufacturing processes meet Food and Drug Administration (FDA), International Organization for Standardization 9001 (ISO 9001), and other regulatory standards. Develop and update Manufacturing and Quality Instructions, test methods, and drawings. Perform root cause analysis and implement corrective actions. Support audits and inspections with proper documentation and traceability. Perform risk assessments, Failure Mode and Effects Analysis (FMEA) and provide feedback on fixturing, tolerancing, and design for manufacturability.

Cross-Functional Collaboration: Partner with Quality, R&D, and Production to support product lifecycle planning, root cause analysis, and continuous improvement initiatives. Mentor technicians and junior engineers in best practices for manufacturing support, documentation, and process improvements

Documentation & Compliance: Author and maintain engineering documentation, such as process specifications, work instructions, batch records, FMEAs, technical reports, training materials, and test protocols, Design History Files (DHFs), regulatory submission documents (FDA, ISO 9001), and equipment manuals. Ensure compliance with regulatory and internal standards (FDA, ISO, SOPs).

Position Requirements:
Bachelor’s degree in Plastics, Manufacturing, Polymer, Materials, Mechanical Engineering, or a related field or equivalent. 

More than one year of experience in a manufacturing setting.

Hands-on experience supporting injection molding processes or operating molding equipment.

Excitement for working in manufacturing environments.

Proficiency with CAD software.

Strong technical writing ability for engineering documentation.

Familiarity with SPC techniques and GD&T principles.

Excellent problem-solving, collaboration, and communication skills.

Preferred:
Experience with sintering furnaces or heat treatment and recipe creation.

Exposure to polymer materials, complex part assembly, or fixture design.

Proficiency with Minitab, SAP/NetWeaver, or PLM systems.

Experience in medical device manufacturing or ISO 9001-regulated industries.

IQ/OQ/PQ validation experience.

Proficiency with SolidWorks.

If you're looking for a role where you be hands-on, work alongside experienced mold makers and process techs, and be deeply involved in real-time problem solving, this is the opportunity for you. Join Applied Medical and help shape the next generation of medical devices through innovative and precise manufacturing processes.

Benefits:
Competitive compensation range: $70,000 - $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 vacation schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

 

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

 

All compensation and benefits are subject to plan documents and written agreements.

 

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.