Systems Engineer, Manufacturing Engineering

Position Overview

The Systems Engineer, Manufacturing Engineering will play a key role in the implementation and optimization of systems and processes for the manufacturing of injection-molded CPAP masks. This is an exciting opportunity to work on challenging projects, collaborate with cross-functional teams, and gain exposure to advanced manufacturing techniques in a regulated, high-precision industry. Main responsibilities include implementation of manufacturing processes, equipment, facilities and documents, to meet the current and future production volume, quality, OHS and cost requirements. Key deliverables include conducting prototyping and verification activities to determine the feasibility/suitability of a design. Assists in the development, execution, and testing of new and existing products.

You will work closely with experts in design, production, and quality assurance, ensuring that all processes meet industry standards while driving innovation and efficiency. This position is ideal for a recent graduate eager to apply their engineering knowledge and build a rewarding career in medical device manufacturing.

Key Responsibilities

• Process Design & Optimization:
• Work with Product Development to develop and maintain a complete, concise validated manufacturing system design that satisfies the product requirements with seamless integration of systems and subsystems
• Implement continuous improvement initiatives using lean manufacturing and Six Sigma principles.
• Conduct process risk analysis to identify all reasonable risks and appropriate mitigations.
• Production Support:
• Analyze production data to identify trends, troubleshoot issues, and recommend corrective actions.
• Work with the operations team to resolve technical challenges, minimizing downtime and ensuring smooth production flow.
• Equipment & Tooling:
• Assist in the design, procurement, and validation of manufacturing equipment and injection molds.
• Conduct tooling trials and support the qualification of new tools for production.
• Validation & Compliance:
• Perform process validations (IQ, OQ, PQ) and maintain documentation to meet regulatory and quality requirements.
• Ensure all manufacturing processes comply with ISO 13485 and other applicable medical device standards.
• Collaboration & Communication:
• Collaborate with R&D, Quality, and Production teams to implement new product designs into manufacturing processes.
• Communicate technical concepts and progress effectively to both technical and non-technical stakeholders.
• Data Analysis & Reporting:
• Utilize data analysis tools to monitor key performance indicators (KPIs) and support decision-making.
• Prepare detailed reports and presentations on process performance and improvement initiatives.
  
  
  

Qualifications

• Bachelor’s degree in Systems Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.
• Strong foundational knowledge of injection molding processes, materials (e.g., thermoplastics, silicones),tooling and related automation (minimum 2-5 years of experience).
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and familiarity with simulation tools (e.g., Moldflow) is preferred.
• Excellent problem-solving skills, with the ability to analyze and interpret complex data.
• Familiarity with regulatory requirements in medical device manufacturing is a plus (e.g., FDA, ISO 13485).
  
  
  

Preferred Skills & Attributes

• Knowledge of statistical process control (SPC) and quality management tools.
• Experience with root cause analysis and corrective action processes.
• Strong organizational and time-management skills, with the ability to handle multiple projects simultaneously.
• Effective communication and interpersonal skills, with a collaborative mindset.
  
  
  

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: 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.

Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this position is:

76,000.00 - 95,000.00 - 113,000.00 USD Annual

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.