Plastics Process Engineer II - Applied Medical

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Company Overview: 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 Overview: Join Applied Medical and be at the forefront of revolutionizing medical device manufacturing. As a Plastics Process Engineer II at Applied Medical, you will play a pivotal role in driving the development, optimization, and maintenance of plastics manufacturing processes for medical device components. You will leverage your expertise to support the company's mission of delivering high-quality medical devices to improve patient outcomes.

Position Description

Key Responsibilities:

• Process Development and Improvement: Enhance manufacturing efficiency and product quality within a cross-functional team by improving existing processes and developing new products.
• Technology development and tooling design: Research and implement technology advancements to improve process capabilities. Design tooling using SolidWorks for prototyping and collaborate with the in-house tooling manufacturing team.
• Customer advisory and prototyping: Advise customers on design for manufacturability and material selection. Prototype concepts, conduct engineering evaluations, and determine feasibility.
• Collaboration with internal and external stakeholders: Work closely with customers to understand product requirements and specifications. Maintain relationships with suppliers and assist in establishing new supplier relationships in coordination with the Procurement team.
• Engineering support and troubleshooting: Provide routine engineering support to improve and maintain manufacturing processes. Utilize root cause analysis for hands-on troubleshooting of processes and equipment.
• Production line planning and qualification: Plan, organize, and qualify production lines for new and existing products, ensuring smooth transition into manufacturing.
• Documentation and quality assurance: Update and develop engineering documents, including manufacturing and quality instructions, test methods, design of experiments, drawings, and test protocols and reports. Comply with SOP’s and ISO 9001 requirements.

Performance Objectives:

Within your first 30 days:

• Complete all Applied Learning foundational courses and familiarize yourself with organizational structure, demonstrating rapid integration into company processes.
• Gain a thorough understanding of current manufacturing processes, equipment, materials, controls, settings, and maintenance procedures used in plastic manufacturing processes.
• Review existing process documentation, including SOPs, manufacturing and quality instructions, quality records, and quality standards, to identify areas for improvement and optimization. Ensure understanding of documentation control processes and requirements.
• Participate in training sessions on product lifecycle management software tools, quality management systems, and regulatory requirements relevant to the medical device industry.
• Establish strong working relationships with cross-functional teams including Product Development, Process Development, Automation, Quality Systems, Regulatory Affairs, and Procurement to understand their roles and how they intersect with Manufacturing.
• Schedule meetings with key stakeholders to understand their expectations, challenges, and priorities, and gather feedback on potential areas for process enhancement.
• Gain a basic understanding of the medical device products manufactured by the company, their intended uses, and critical performance requirements. Review product specifications, drawings, and related documentation.
• Familiarize yourself with the regulatory landscape governing medical device manufacturing, including FDA regulations, ISO 9001, and other relevant standards. Review quality management system (QMS) documentation related to regulatory compliance.

Within 60 days:

• Conduct detailed analysis of manufacturing processes, identify inefficiencies, and propose solutions for enhanced productivity and quality.
• Lead improvement projects, collaborating with teams to track progress against metrics. Implement process improvements, evaluating their impact on key performance indicators such as yield, cycle time, and product consistency.
• Conduct risk assessments and implement mitigation strategies to ensure robust manufacturing processes. Develop validation plans for critical process parameters, equipment, and materials in accordance with regulatory requirements.          
• Complete root cause analysis training and apply techniques to address recurring manufacturing issues or quality deviations.
• Begin updating and maintaining process documentation, ensuring accuracy and compliance with regulatory standards. Review and update documentation to ensure regulatory compliance, including SOPs, work instructions, and quality records.
• Foster collaboration across departments, actively seeking input from stakeholders for process improvement initiatives.

Within 90 days to one year:

• Successfully implement process improvement projects, integrating changes into production to enhance efficiency and quality. Establish systems for ongoing monitoring and optimization of manufacturing processes, including performance reviews and data analysis.
• Evaluate existing plastics manufacturing processes, identify areas for improvement, and develop enhancement plans. Prioritize projects based on impact on product quality and operational efficiency.
• Initiate and execute validation activities for critical process parameters and set up communication channels for progress updates and reporting on key performance indicators.
• Take ownership of tasks and projects, demonstrating proactive leadership and problem-solving skills to drive continuous improvement.
• Take on leadership roles within the process engineering team, providing guidance and mentorship. Collaborate with cross-functional teams to understand project priorities and expectations.
• Initiate meetings with key stakeholders and review historical performance data and documentation. Identify gaps and develop improvement initiatives accordingly.

Position Requirements

• Two years of practical engineering experience in relevant fields.
• Bachelor’s degree in Polymer, Materials, Plastics, or Manufacturing Engineering (or equivalent).
• Proficiency in operating manufacturing equipment and injection molding processes.
• Experience using computer-aided design software such as SolidWorks, as well as spreadsheets, scheduling programs, and word processing.
• Familiarity with Statistical Process Control (SPC) techniques.
• Working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Understanding of various materials and mechanical designs.
• Strong ability to collaborate within cross-functional teams.
• Exceptional oral and written communication skills, including technical writing proficiency.
• Detail-oriented with a strong technical aptitude.
• Proficient in critical thinking and problem-solving.
• Ability to mentor and provide guidance to other team members when necessary.

Preferred

• Previous experience in Polymer-related projects or industries.
• Familiarity with medical device industry and its regulatory requirements.
• Understanding of manufacturing and quality standards, including FDA regulations and ISO quality systems.
• Proficiency with software platforms like NetWeaver/Product Lifecycle Management (PLM).
• Experience using statistical analysis software such as Minitab or similar programs.
• Demonstrated leadership or project management experience.

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles.

Benefits

• Competitive compensation range: $75000 - $95000 / 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 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 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 status protected by federal, state or local laws in the locations where Applied Medical operates.