Manufacturing Process Engineer

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 be at the forefront of revolutionizing medical device manufacturing. As a Manufacturing Process Engineer II at Applied Medical, you will play a pivotal role in driving the development, optimization, and maintenance of manufacturing processes for medical device components. The successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. You will leverage your expertise to support the company's mission of delivering high-quality medical devices to improve patient outcomes.
Key Responsibilities:
Process Optimization and Improvement: Analyze and optimize manufacturing processes for efficiency, quality, and cost-effectiveness. Lead continuous improvement initiatives. Implement process control plans to improve quality and reduce variation. Develop and sustain manufacturing processes as part of a cross-functional team. Identify and resolve process inefficiencies and bottlenecks.
Manufacturing Support: Provide technical support to manufacturing teams. Troubleshoot and resolve equipment, process, and system issues through root cause analysis. Run, observe, and expedite shop orders to maintain manufacturing flow and improve uptime. Research and qualify new suppliers and vendors to support manufacturing needs.
Equipment and Tooling Management: Manage the selection, installation, and calibration of manufacturing equipment. Ensure equipment reliability through preventive maintenance and qualification. Collaborate with tooling design teams to optimize tooling performance. Investigate new tooling, materials, and technologies to improve manufacturing processes.
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.
Documentation and Reporting: Develop and maintain engineering documents, including process maps, process FMEA, Manufacturing and Quality Instructions, test methods, reports, and drawings. Ensure compliance with standard operating procedures (SOPs) and ISO 9001 standards, maintaining records of changes and process improvements.
Cross-Functional Collaboration: Work with various device engineering teams and other cross-functional teams such as Quality, Mold Design, and Process Experts to ensure compliance and manufacturability. Collaborate with the Production team to identify manufacturing capabilities and capacity. Contribute to product lifecycle planning and risk management strategies.
Data Analysis and Reporting: Collect and analyze manufacturing data to monitor performance and identify trends. Track key performance indicators and recommend process improvements. Use data-driven insights to optimize manufacturing and support decision-making.
Training and Development: Mentor and train junior engineers, manufacturing operators, and technicians. Foster skill development to enhance team performance.
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 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 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 robustness of 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.
Attend relevant training sessions and pursue professional development opportunities to stay updated on industry trends and regulatory requirements.
Conduct evaluations of key suppliers to enhance the supply chain.
Ensure compliance with regulatory standards like FDA regulations and ISO 9001, participating in audits, as required.
Position Requirements Bachelor's degree in Manufacturing, Mechanical, Biomedical, Chemical, Material Science Engineering or equivalent.
More than two years of practical engineering experience in relevant fields.
Proficiency in operating manufacturing equipment.
Experience using computer-aided design (CAD) software such as SolidWorks.
Experience with 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 materials industries.
Familiarity with the 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 and 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: $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 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.

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