Manufacturing Engineer (2nd Shift)

ResMed • Calabasas, CA

1d • $79,000 - $119,000 • Onsite

About The Position

The Manufacturing Engineer (Liquid Silicone Rubber Molding) is a critical role responsible for supporting production lines and manufacturing processes for Liquid Silicone Rubber (LSR) molding operations. This position involves driving execution of molding technologies, improving efficiency, and ensuring compliance with global quality and regulatory standards in the medical device industry. The role will also include collaboration with cross-functional teams, vendors, and management to deliver high-quality products while achieving cost and productivity targets.

Requirements

• Bachelor’s degree in mechanical engineering, Plastics Engineering, Manufacturing Engineering, or a related field.
• Minimum 3+ years of experience in Manufacturing Engineering (Ideally with Injection Molding/LSR Manufacturing).
• Experience supporting production lines in 24X7 environments.
• Hands-on experience with Molding machines and robotic automation.
• Proven track record in leading and supporting engineering projects in highly collaborative environments.
• Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols.
• Proficient in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab, JMP).

Nice To Haves

• Master’s degree in engineering field.
• Familiarity with medical device manufacturing and associated regulatory requirements.
• Knowledge of process monitoring systems (e.g., RJG, Kistler).
• Six Sigma Green Belt or higher certification.
• Strong leadership and project management skills, with a PMP certification preferred.

Responsibilities

• Validate robust manufacturing processes for LSR molding.
• Drive revalidation activities for process/tool/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, ensuring consistent product quality.
• Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks.
• Serve as the technical lead in root cause investigations and implementing countermeasures.
• Coordinate with vendors and suppliers for equipment selection, procurement, and commissioning.
• Provide regular updates to stakeholders, including management, on project status and milestones.
• Ensure all processes meet ISO 13485 and FDA regulations for medical device manufacturing.
• Develop and maintain detailed documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs).
• Ensure compliance with electrical and regulatory requirements for North American and European markets.
• Partner with Quality, Manufacturing Engineering, and Production teams to resolve process challenges.
• Work with Design Engineering to provide feedback on part designs for manufacturability (DFM).
• Research and integrate emerging technologies in LSR molding to improve efficiency and reduce waste.
• Lead initiatives for automation, such as robotic part handling and lights-out manufacturing.

Benefits

• comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
• Fifteen days Paid Time Off (PTO) in their first year of employment.
• 11 paid holidays plus 3 floating days.
• 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level