Senior Engineer, Manufacturing Engineering (Thermoplastics and LSR Molding)

The Senior Engineer, Manufacturing Engineering (Thermoplastics and LSR Molding) is a critical role responsible for designing, optimizing, and implementing manufacturing processes for thermoplastic and Liquid Silicone Rubber (LSR) molding operations. This position involves driving the development and execution of cutting-edge two-shot 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.

Key Responsibilities:

Process Design and Optimization:

• Develop and validate robust manufacturing processes for thermoplastics and LSR molding, including two-shot molding.
• 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 for setting up new manufacturing cells, including lights-out automated molding systems.
• Coordinate with vendors and suppliers for equipment selection, procurement, and commissioning.
• Develop and manage project timelines, budgets, and deliverables to ensure on-time, cost-effective implementation.
• Provide regular updates to stakeholders, including executive 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 standard operating procedures (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).
• Support finance and management teams in cost analysis and budgeting for new process development.

Innovation and Continuous Improvement:

• Research and integrate emerging technologies in thermoplastics and LSR molding to improve efficiency and reduce waste.
• Lead initiatives for automation, such as robotic part handling and lights-out manufacturing.
• Provide training and mentorship to junior engineers and technicians on molding technologies.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Plastics Engineering, Manufacturing Engineering, or a related field (Master’s preferred).
• Minimum 5+ years of experience in thermoplastics or LSR molding, including two-shot or overmolding processes.
• Proven track record in implementing and optimizing automated molding systems.
• Hands-on experience with mold design, material selection, and troubleshooting molding defects.
• 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:

• Experience with lights-out manufacturing and robotic automation.
• 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.

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 quali