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.