Sr. Plastics Extrusion Engineer - Intellectt INC
Portland, OR
About the Job
Sr. Plastics Extrusion Engineer.
Location: Portland, OR
Position: Mid-Senior to Senior Level Extrusion Engineer (Single Lumen and Micro-Extrusion Focus)
Technical Knowledge Requirements:
- Material Science:
- In-depth understanding of medical-grade polymers and their properties. (PCV, PFA, FEP, ETFE, CarboSil, PEEK, Bionate, PEBAX, Optim)
- Knowledge of biocompatibility and sterilization processes.
- Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
- Extrusion Processes:
- Expertise in single lumen extrusion, core and single conductor extrusion, and micro-extrusion techniques.
- Proficiency in designing and optimizing extrusion dies and tooling, including the selection and pairing of tooling capable of meeting product outputs, analyzing defects, troubleshooting, and making recommendations for corrections to tooling, processes, or other related issues.
- Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
- Process Development:
- Demonstrated expertise in developing and optimizing extrusion processes for medical devices, including the establishment of processing windows and failure limits, standardizing process inputs through product bracketing, and visualizing outputs to determine key performance indicators (KPIs) for effective monitoring.
- Proven ability to troubleshoot and resolve process issues, ensuring consistent product quality and adherence to regulatory standards.
- Extrusion Equipment Knowledge:
- Comprehensive knowledge of extrusion equipment, encompassing installation, troubleshooting, and resolution of technical issues.
- Proficiency in implementing preventive maintenance (PM) and unplanned maintenance (UM) strategies to ensure optimal equipment performance and minimize downtime.
- Expertise in calibration processes to maintain equipment accuracy and compliance with industry standards.
- Validation and Compliance:
- Comprehensive knowledge of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation processes.
- Familiarity with ISO 13485 standards and FDA regulations for medical devices.
- Experience in conducting risk assessments and implementing corrective actions, PFMEA, DFMEA.
- Quality Assurance:
- Proficiency in quality control methods and statistical process control (SPC).
- Ability to develop and implement quality assurance protocols and procedures.
- Industry Experience:
- Minimum of 5-7 years of experience in medical device extrusion engineering, with a focus on single lumen and micro-extrusion.
- Proven track record of successful process development and optimization in a regulated environment.
- Project Management:
- Experience in leading and managing extrusion projects from concept to production.
- Ability to work collaboratively with cross-functional teams, including R&D, quality assurance, and regulatory affairs.
- Technical Leadership:
- Demonstrated ability to mentor and guide junior engineers and technicians.
- Strong problem-solving skills and the ability to make data-driven decisions.
- Education:
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related field. A Master's degree is preferred.
- Skills:
- Excellent communication and interpersonal skills.
- Strong analytical and critical thinking abilities.
- Proficiency in CAD software and other relevant engineering tools.
- Strong teamwork etiquette, with a focus on effective communication and collaboration.
- Demonstrated ability to maintain a goal-oriented mindset, emphasizing the achievement of objectives and overcoming obstacles
Source : Intellectt INC