Engineer, Process - Senior

Röchling Medical•Rochester, MN

12d•Hybrid

About The Position

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. Essential Duties and Responsibilities: Lead hands-on injection molding process development for new and existing products using scientific molding principles to establish robust, repeatable, and efficient processing windows. Plan and execute mold trials, process characterization, parameter development, and optimization, including evaluation of fill, pack, cooling, recovery, pressure, temperature, cycle time, cavity balance, and process capability. Serve as the primary technical resource for complex molding problems. Use structured troubleshooting, root-cause analysis, machine and process data, and controlled experimentation to resolve defects, variation, downtime, and recurring process issues. Analyze process and quality data using statistical methods and tools such as Minitab. Evaluate trends, variation, capability, correlations, and risk to support sound technical decisions and sustainable corrective actions. Design and execute statistically sound design of experiments (DOE) to identify critical process inputs, quantify interactions, optimize performance, and establish operating and reaction limits. Develop and execute molding validation activities, including protocol development and IQ, OQ, and PQ execution, data analysis, report completion, deviation resolution, and transfer of validated processes into production. Partner closely with Tool Engineering, Product Engineering, Quality, Automation, and Manufacturing during DFM reviews to assess part geometry, resin selection, gate and runner strategy, venting, cooling, ejection, steel conditions, tolerances, and manufacturability before tool release. Support mold design reviews, tool construction, sampling, qualification, and sign-off. Translate trial findings into clear recommendations for tool modifications and verify that corrective changes achieve the intended result. Define production-ready process documentation, including approved setup sheets, process windows, control plans, troubleshooting guides, work instructions, water diagrams, auxiliary equipment requirements, and standardized startup and shutdown methods. Provide technical coaching and escalation support to Process Engineers, Setup Technicians, and Production personnel while remaining directly engaged at the press during development, validation, and troubleshooting activities. Lead or support investigations involving nonconformances, CAPAs, customer concerns, and recurring defects, ensuring root causes are supported by evidence and corrective actions are verified for effectiveness. Drive continuous improvement in quality, scrap, cycle time, OEE, labor utilization, automation performance, and process consistency through disciplined engineering methods and sustainable standardization. Evaluate injection molding machines, tooling, automation, auxiliary equipment, and emerging technologies; provide technical recommendations supporting new product introduction, capacity, reliability, and cost improvement. Manage assigned technical projects, trial schedules, priorities, documentation, and cross-functional actions to meet program and production commitments.

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, including development of robust processing windows and evidence-based reaction limits.
Demonstrated ability to analyze complex process and quality data using statistical methods, process capability, trend analysis, and Minitab or equivalent software.
Demonstrated experience planning, executing, and interpreting DOE studies and converting results into practical process controls.
Working knowledge of regulated-process validation, including IQ, OQ, PQ, protocol execution, deviation management, statistical analysis, and final reporting.
Deep technical knowledge of injection molding machines, molds, hot runner systems, resins, dryers, temperature-control units, material-handling systems, robotics, vision systems, and related peripheral equipment.
Strong understanding of mold construction and DFM principles, with the ability to identify manufacturability risks and communicate technically sound recommendations to Tool Engineering and cross-functional teams.
Structured problem-solving and root-cause-analysis skills with the ability to separate symptoms from verified causes and implement sustainable corrective actions.
Ability to communicate technical conclusions clearly through reports, validation documents, presentations, setup standards, and direct coaching at the press.
Ability to lead technical work and influence cross-functional teams without direct supervisory authority while managing multiple priorities in a fast-paced manufacturing environment.
Bachelor’s degree in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field, or demonstrated knowledge and experience in injection molding process engineering.
Minimum of 8 years of hands-on injection molding process engineering experience with ownership of process development, troubleshooting, and validation.

Nice To Haves

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.

Responsibilities

Lead hands-on injection molding process development for new and existing products using scientific molding principles to establish robust, repeatable, and efficient processing windows.
Plan and execute mold trials, process characterization, parameter development, and optimization, including evaluation of fill, pack, cooling, recovery, pressure, temperature, cycle time, cavity balance, and process capability.
Serve as the primary technical resource for complex molding problems. Use structured troubleshooting, root-cause analysis, machine and process data, and controlled experimentation to resolve defects, variation, downtime, and recurring process issues.
Analyze process and quality data using statistical methods and tools such as Minitab. Evaluate trends, variation, capability, correlations, and risk to support sound technical decisions and sustainable corrective actions.
Design and execute statistically sound design of experiments (DOE) to identify critical process inputs, quantify interactions, optimize performance, and establish operating and reaction limits.
Develop and execute molding validation activities, including protocol development and IQ, OQ, and PQ execution, data analysis, report completion, deviation resolution, and transfer of validated processes into production.
Partner closely with Tool Engineering, Product Engineering, Quality, Automation, and Manufacturing during DFM reviews to assess part geometry, resin selection, gate and runner strategy, venting, cooling, ejection, steel conditions, tolerances, and manufacturability before tool release.
Support mold design reviews, tool construction, sampling, qualification, and sign-off. Translate trial findings into clear recommendations for tool modifications and verify that corrective changes achieve the intended result.
Define production-ready process documentation, including approved setup sheets, process windows, control plans, troubleshooting guides, work instructions, water diagrams, auxiliary equipment requirements, and standardized startup and shutdown methods.
Provide technical coaching and escalation support to Process Engineers, Setup Technicians, and Production personnel while remaining directly engaged at the press during development, validation, and troubleshooting activities.
Lead or support investigations involving nonconformances, CAPAs, customer concerns, and recurring defects, ensuring root causes are supported by evidence and corrective actions are verified for effectiveness.
Drive continuous improvement in quality, scrap, cycle time, OEE, labor utilization, automation performance, and process consistency through disciplined engineering methods and sustainable standardization.
Evaluate injection molding machines, tooling, automation, auxiliary equipment, and emerging technologies; provide technical recommendations supporting new product introduction, capacity, reliability, and cost improvement.
Manage assigned technical projects, trial schedules, priorities, documentation, and cross-functional actions to meet program and production commitments.