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Production Optimization Specialist

2 months ago

Pleasanton, California, United States Calyxo USA Inc Full time
About the Role

Calyxo USA Inc. is a leading medical device company seeking a highly skilled Manufacturing Process Engineer to join our team. As a key member of our production team, you will be responsible for leading technical projects and optimizing manufacturing processes to improve efficiency, quality, and productivity.

Key Responsibilities
  • Initiate, own, and complete technical projects to improve manufacturing processes and reduce costs.
  • Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to design and develop processes that meet customer demand while promoting product quality and process efficiency.
  • Design and develop manufacturing procedures, tooling, and fixtures to optimize production capacity and reduce variability.
  • Provide sustaining production line support, including process improvements, equipment troubleshooting, and operator training.
  • Generate and modify high-quality manufacturing process documentation to ensure compliance with established policies and procedures.
  • Utilize LEAN, Six Sigma, and other best practice tools and principles to drive continuous improvement and problem-solving.
  • Assist in identifying equipment needs and evaluating internal and external options for sourcing.
  • Generate and modify component/assembly/equipment drawings using Solidworks.
  • Write and execute process and equipment validations (IQ/OQ/PQ).
  • Work with external vendors as needed.
  • Perform equipment maintenance and ensure product quality and regulatory compliance.
Requirements
  • Education: Bachelor of Science in Engineering or a combination of relevant education and experience.
  • Minimum 3 years' experience supporting medical device manufacturing.
  • Work location: Pleasanton, CA.
  • Travel: < 5%.
  • Full-time employment.
  • Experience in leading technical projects in a cross-functional environment.
  • Experience working in a structured design process, such as ISO 9000 or FDA QSR, and knowledge of regulatory approval processes and requirements.
  • Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485 or ISO 9001 and EN 46001.
  • Excellent computer skills, including proficiency in Microsoft Office and SolidWorks.
  • Desirable: Experience with electronic components/assembly in the context of medical device capital equipment.
  • Desirable: Experience designing, building, and implementing manufacturing fixtures and processing aids.
  • Compliance with relevant county, state, and Federal rules regarding vaccinations.
What We Offer
  • Competitive salary ($103,000 - $122,000 annually).
  • Stock options - ownership and a stake in growing a mission-driven company.
  • Employee benefits package, including 401(k), healthcare insurance, and Paid Time Off (PTO).

Calyxo USA Inc. is committed to fostering an environment where diversity and inclusion are valued and prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.

Calyxo USA Inc. is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.