Manufacturing Engineer

Responsibilities

• Validate robust manufacturing processes for Liquid Silicone Rubber (LSR) molding.
• Drive revalidation activities for process, tool, and equipment changes in production.
• Lead process improvement initiatives to enhance productivity, cycle time, and material utilization.
• Design experiments and analyze data to optimize process parameters.
• Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks.
• Serve as the technical lead in root cause investigations and implement countermeasures.
• Coordinate with vendors for equipment selection, procurement, and commissioning.
• Ensure all processes meet ISO 13485 and FDA regulations for medical device manufacturing.
• Maintain detailed documentation, including work instructions and validation protocols (IQ, OQ, PQ).
• Research and integrate emerging technologies, such as robotic automation and lights-out manufacturing.

Requirements

• Bachelor’s degree in Mechanical, Plastics, or Manufacturing Engineering (or a related field).
• 3+ years of Manufacturing Engineering experience, ideally with Injection Molding or LSR manufacturing.
• Hands-on experience with molding machines and robotic automation.
• Experience supporting production lines in 24/7 environments.
• Strong knowledge of quality systems, including ISO 13485 and FDA regulations.
• Proficiency in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab, JMP).

Preferred Qualifications

• Master’s degree in an engineering field.
• Familiarity with medical device manufacturing and associated regulatory requirements.
• Knowledge of process monitoring systems such as RJG or Kistler.
• Six Sigma Green Belt or higher certification.
• PMP certification or strong project management skills.

Benefits

• Comprehensive medical, vision, dental, and life insurance.
• 401(k) and Employee Stock Purchase Plan (ESPP).
• Paid Time Off (PTO), 11 paid holidays, and 3 floating days.
• Tuition assistance and professional development opportunities.
• Health Savings Account (HSA) and Flexible Spending Account (FSA).

About the Company

ResMed creates life-changing health technologies that empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions and cloud-connected devices make home healthcare more personalized, accessible, and effective.