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.

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

Requirements

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)

Nice to have

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

Benefits

Competitive benefits; Professional development opportunities; Opportunity to contribute to products that improve lives globally; Comprehensive medical, vision, dental, and life insurance; AD&D insurance; 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); Tuition assistance; 15 days Paid Time Off (PTO) in first year; 11 paid holidays plus 3 floating days; 14 weeks of primary caregiver or 2 weeks of secondary caregiver leave