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About the Role
Röchling Medical is seeking an experienced professional to join their team, focusing on improving lives through innovation in health by developing customized products and solutions for the pharmaceutical, biotech, and medical device industries.
Responsibilities
- Lead hands-on injection molding process development for new and existing products using scientific molding principles.
- Plan and execute mold trials, process characterization, parameter development, and optimization.
- Serve as the primary technical resource for complex molding problems, utilizing structured troubleshooting and root-cause analysis.
- Analyze process and quality data using statistical methods and tools like Minitab.
- Design and execute statistically sound design of experiments (DOE).
- Develop and execute molding validation activities, including protocol development and IQ, OQ, PQ execution.
- Partner closely with Tool Engineering, Product Engineering, Quality, Automation, and Manufacturing during DFM reviews.
- Support mold design reviews, tool construction, sampling, qualification, and sign-off.
- Define production-ready process documentation, including setup sheets, process windows, and control plans.
- Provide technical coaching and escalation support to Process Engineers, Setup Technicians, and Production personnel.
- Lead or support investigations involving nonconformances, CAPAs, customer concerns, and recurring defects.
- Drive continuous improvement in quality, scrap, cycle time, OEE, and process consistency.
- Evaluate injection molding machines, tooling, automation, auxiliary equipment, and emerging technologies.
- Manage assigned technical projects, trial schedules, priorities, and documentation.
Requirements
- Expert-level hands-on experience in injection molding process development, optimization, and troubleshooting in a production environment.
- Strong command of scientific molding principles and process characterization.
- Demonstrated ability to analyze complex process and quality data using statistical methods and Minitab or equivalent software.
- Demonstrated experience planning, executing, and interpreting DOE studies.
- Working knowledge of regulated-process validation, including IQ, OQ, PQ, protocol execution, and deviation management.
- Deep technical knowledge of injection molding machines, molds, hot runner systems, resins, and related peripheral equipment.
- Strong understanding of mold construction and DFM principles.
- Structured problem-solving and root-cause-analysis skills.
- Ability to communicate technical conclusions clearly through reports, validation documents, presentations, and coaching.
- Ability to lead technical work and influence cross-functional teams while managing multiple priorities.
Skills
- Injection molding process development
- Scientific molding principles
- Process characterization
- Statistical analysis
- Minitab
- Design of Experiments (DOE)
- Process validation (IQ, OQ, PQ)
- Mold construction
- DFM principles
- Root-cause analysis
- Technical communication
- Project management
Location
- Remote
Work Type
- Mobile work
Experience Level
- Minimum of 8 years of hands-on injection molding process engineering experience
Education Level
- Bachelor’s degree in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field, or demonstrated knowledge and experience in injection molding process engineering.
- Formal scientific molding training or certification, such as RJG Master Molder, AIM, or equivalent, strongly preferred.
- Experience in a regulated manufacturing environment, preferably medical device manufacturing, strongly preferred.
Benefits
- Health offerings, such as a health clinic
- Tailored training programs
- Vending machines with snacks and food options
- Mobile work is possible
About the Company
- At Röchling Medical, we're united by a shared purpose: improving lives through innovation in health.
- As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives.