Senior Moulding Engineer: Medical-Device Process Innovator

ResMed Inc; Calabasas (CA); Hybrid; USD 117,000 - 175,000; Full time

Benefits offered by this job

Comprehensive medical

Vision insurance

Dental insurance

Life insurance

Disability insurance

401(k)

Employee Stock Purchase Plan (ESPP)

PTO and holidays

Job summary

ResMed Inc. is seeking a Senior Moulding Engineer to own the end-to-end development of complex molding programs, including multi-cavity and two-shot molding. You will lead process development, validation, and transfer to production, ensuring compliance with ISO 13485 and FDA regulations.

You will mentor engineers, collaborate with cross-functional teams, and drive continuous improvement in molding capability and efficiency.

Qualifications

• Bachelor’s degree in mechanical engineering, Plastics Engineering, Polymer Engineering, or related field; master’s preferred.
• Minimum 5+ years of injection molding process engineering in medical-device or regulated manufacturing.
• Proficient in CAD (SolidWorks) and data analysis tools (Minitab, JMP).

Responsibilities

• Develop and validate robust molding processes for thermoplastics and LSR, including two-shot molding; improve productivity and material utilization.
• Lead setup of new manufacturing cells, coordinate equipment selection, procurement, and commissioning; manage timelines and budgets.
• Ensure ISO 13485 and FDA compliance; develop documentation, IQ/OQ/PQ protocols, and SOPs.
• Collaborate with Quality, Manufacturing, and Design Engineering to resolve challenges and improve manufacturability.

Skills

Mold design

Process engineering

Data analysis

SolidWorks

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Minitab

JMP

Job description

ResMed Inc. is seeking a Senior Moulding Engineer to own the end-to-end development of complex molding programs, including multi-cavity and two-shot molding. You will lead process development, validation, and transfer to production, ensuring compliance with ISO 13485 and FDA regulations.

You will mentor engineers, collaborate with cross-functional teams, and drive continuous improvement in molding capability and efficiency.