Extrusion Engineer

Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.

• Santa Clara, CA
• R&D / Manufacturing Engineering
• Contract to Hire
• Position Summary :

We are seeking a highly skilled and experienced

• Senior Extrusion Engineer
• to lead the development, optimization, and scale-up of extrusion processes for medical device components. This role is critical to ensuring the production of high-quality, precision extruded tubing and profiles that meet stringent regulatory and performance standards. The ideal candidate will bring deep technical expertise, leadership capabilities, and a passion for innovation in medical device manufacturing.
• Key Responsibilities :
• Lead the design, development, and validation of extrusion processes for thermoplastics, fluoropolymers, and other medical-grade materials.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to support new product development and continuous improvement initiatives.
• Develop and optimize tooling, dies, and downstream equipment to ensure consistent product quality and process efficiency.
• Conduct root cause analysis and implement corrective actions for process deviations and non-conformances.
• Author and review technical documentation including process validations, protocols, and reports in compliance with FDA and ISO standards.
• Mentor junior engineers and technicians, providing technical guidance and training.
• Stay current with industry trends, emerging technologies, and regulatory changes affecting extrusion and medical device manufacturing.
• Qualifications :
• Bachelor’s or Master’s degree in Mechanical Engineering, Polymer Science, Materials Engineering, or related field.
• Minimum 7+ years of hands-on experience in extrusion engineering, preferably in the medical device industry.
• Strong knowledge of polymer behavior, extrusion equipment, and process controls.
• Experience with multi-lumen, microbore, and co-extrusion processes is highly desirable.
• Familiarity with GMP, ISO 13485, and FDA regulations.
• Proficient in CAD software and statistical analysis tools (e.g., Minitab, JMP).
• Excellent problem-solving, communication, and project management skills.
• Preferred Skills :
• Experience with automation and advanced process monitoring systems.
• Knowledge of materials such as Pebax, PEEK, PTFE, and polyurethane.
• Six Sigma or Lean Manufacturing certification.
• Why Join Us?
• Work on cutting-edge technologies that improve patient outcomes.
• Be part of a collaborative and innovative team.
• Competitive compensation and benefits.
• Opportunities for professional growth and leadership.

_Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws._

Job Types : Full-time, Contract

Pay : $50.00 - $70.00 per hour

Expected hours : 40 per week

Benefits :

• Dental insurance
• Health insurance
• Vision insurance

Work Location : In person