Manufacturing Engineer

Resmed; Calabasas (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Comprehensive medical, vision, and dental insurance

401(k) and Employee Stock Purchase Plan

Paid Time Off (PTO) including caregiver leave

Job summary

Resmed in Calabasas, California, is seeking a Manufacturing Engineer focused on supporting production for Liquid Silicone Rubber (LSR) molding operations. The role involves process optimization, project management, and ensuring compliance with global quality standards in medical devices.

The ideal candidate will possess a Bachelor's degree in Mechanical Engineering and at least 3 years of experience in a related field, with strong knowledge of quality systems and proficiency in CAD software.

Qualifications

• Minimum 3+ years of experience in Manufacturing Engineering, ideally with Injection Molding/LSR.
• Experience supporting production lines in 24x7 environments.
• Strong track record in leading engineering projects collaboratively.

Responsibilities

• Validate manufacturing processes for Liquid Silicone Rubber molding.
• Lead process improvement initiatives to enhance productivity.
• Ensure compliance with ISO 13485 and FDA regulations.

Skills

Mechanical Engineering

Injection Molding

Robotic Automation

Quality Systems

CAD Software

Data Analysis Tools

Education

Bachelor’s degree in Mechanical Engineering or related field

Tools

SolidWorks

Minitab

JMP

Job description

Monday to Friday 1 PM‑10 PM.

Manufacturing Engineer (Liquid Silicone Rubber Molding)

The Manufacturing Engineer is responsible for supporting production lines and manufacturing processes for Liquid Silicone Rubber (LSR) molding operations. The role drives execution of molding technologies, improves efficiency, and ensures compliance with global quality and regulatory standards in the medical device industry. Collaboration with cross‑functional teams, vendors, and management to deliver high‑quality products while achieving cost and productivity targets is also required.

Responsibilities

Process Optimization:

• Validate robust manufacturing processes for LSR molding.
• Drive revalidation activities for process / tool / equipment changes.
• 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.

Project Management:

• 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.

Regulatory Compliance and Documentation:

• 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 SOPs.
• Ensure compliance with electrical and regulatory requirements for North American and European markets.

Collaboration and Cross‑Functional Support:

• 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).

Innovation and Continuous Improvement:

• 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.

Qualifications and Experience

Required Qualifications:

• 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).

Preferred Qualifications:

• 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.

Core Competencies

• Analytical problem‑solving and decision‑making skills.
• Excellent communication and interpersonal abilities.
• Detail‑oriented with a strong commitment to quality and compliance.
• Ability to manage multiple priorities in a fast‑paced, dynamic environment.
• Team player with a proactive approach to innovation and continuous improvement.

Benefits

• Comprehensive medical, vision, dental, and life insurance.
• 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.
• Paid Time Off (PTO): fifteen days in the first year, 11 paid holidays, and 3 floating days.
• Primary caregiver leave (14 weeks) and secondary caregiver leave (2 weeks).

Equal Opportunity Employer

ResMed is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.