Senior Moulding Engineer (Onsite)

The Senior Moulding Engineer owns scientific molding process development and qualification for thermoplastic, LSR, and over molding programs. Independently develops, defends, and releases molding processes to standard, and raises the molding capability of less-experienced engineers. This is the team's independent technical owner of the molding process - the person whose signature on a molding qualification means the process is sound.

Scope and accountability

Owns complex, multi-cavity and multi-tool molding programs end to end: from DFM input through process development, validation (IQ/OQ/PQ), and transfer to production. Leads and manages the timeline, risk, and resources of their own programs. Serves as the molding technical reference for Engineer I/II and for cross-functional partners in Quality, Tooling, and Production.

Let’s talk about 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).

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
• Drive CI Improvement projects for Molding department

Let’s talk about Qualifications and Experience

Required Qualifications:

• Bachelor’s degree in mechanical engineering, Plastics Engineering, Polymer Engineering, or a related field (master’s preferred).
• Minimum 5+ years of injection molding process engineering experience in medical-device or another regulated manufacturing environment
• 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.
• Scientific or decoupled molding certification, such as RJG Master Molder or equivalent
• Six Sigma Green Belt or higher certification.
• Strong leadership and project management skills, with a PMP certification preferred.

Core Competencies:

Competency area: Demonstrated behaviors

Scientific molding & process development: Develops and defends a decoupled molding process window using viscosity curves, cavity-balance, gate-freeze, and pressure-drop studies; resolves molding defects through data rather than trial and error.

Materials science: Selects and justifies resin or LSR based on shrinkage, rheology, cure, and biocompatibility requirements; anticipates material-related defects.

Tooling & DFM: Reviews mold designs for gating, venting, cooling, and moldability; defines and evaluates tool qualification requirements.

Automation & equipment: Sets up and troubleshoots injection molding machines and 6 axis Fanuc Robot with EOAT; defines process-specific automation requirements. Basic understanding of automation for injection molding

Metrology & statistics: Performs GR&R/MSA, Cpk analysis, and DOE; makes and defends data-based decisions.

Validation & quality systems: Authors and execute IQ/OQ/PQ protocols and reports; manages process change control and NCMR/CAPA activities.

EHS & 6S: Works independently to California EHS and 6S standards and incorporates them into process design.

Project & program management: Owns program schedules, risks, and resources and delivers assigned molding programs to plan.

Business & cost acumen: Understands and improves process cost per part, scrap, and OEE.

Communication & influence: Writes defensible process reports and clearly presents process decisions to leadership and APAC partners.

Ownership & judgment: Takes ownership of outcomes, escalates appropriately, and exercises sound judgment amid ambiguity.

Developing others: Trains and mentors Junior Engineers in molding fundamentals.

Why Join Us?

At ResMed you will have the opportunity to work on transformative manufacturing technologies in a collaborative and innovative environment. We offer competitive benefits, professional development opportunities, and a chance to contribute to products that improve lives globally.

Equal Opportunity Employer:

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

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 base range for this position is: $117,000 to $175,000.

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.