Bachelor's degree in Biomedical, Mechanical or Industrial engineering, or equivalent, plus 5+ years of experience as a Manufacturing Process Engineer in Medical Devices.
Proficiency in statistical analysis methods for process development and control, with Minitab experience preferred.
Demonstrated expertise in chemical and process engineering.
Working knowledge of process engineering software, such as SolidWorks.
Experience in Lean Manufacturing with Six Sigma certification.
Familiarity with ISO 13485/ISO 9000 standards.
Hands-on experience with IQ/OQ/PQ protocols.
Responsibilities
Evaluate and enhance manufacturing processes through research and collaboration with vendors and operators.
Oversee the manufacturing process for high-pressure catheter balloons, ensuring quality through rigorous testing.
Manage the installation and qualification of manufacturing equipment, particularly for injection molding and catheter production.
Document and execute comprehensive process development and validations, including risk management and statistical analysis.
Enhance manufacturing efficiency by optimizing workflow and equipment layouts using statistical approaches.
Design and implement custom manufacturing fixtures and equipment to streamline operations.
Assist Manufacturing Supervisor by generating insights on production costs and future requirements.
Benefits
Comprehensive health insurance and well-being programs.
Retirement savings plan with company match.
Opportunities for professional development and continuing education.
Flexible work hours and potential remote work options.
Collaborative and innovative working environment.
Full Job Description
Responsibilities:
Evaluate and develop manufacturing processes, design and conduct research programs; apply knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
Responsible for manufacturing process of high-pressure catheter balloons using pleat and fold processes, testing via vacuum leak and high-pressure testing.
Responsible for installation and qualification of all manufacturing equipment including injection molding equipment and balloon catheter pleat/fold equipment.
Plan, document and execute process development and process validations including IQ/OQ/PQ, drafting protocol/reports, risk management (PFMEA), and statistical data analysis.
Improve manufacturing efficiency by analyzing and planning workflow, space requirements and equipment layouts using statistical methods.
Design and implement manufacturing fixtures and equipment.
Support Manufacturing Supervisor by providing manufacturing decision-making information; calculating production, labor and material costs; reviews production schedules; estimates future requirements.
Requirements:
Bachelor's degree in Biomedical, Mechanical or Industrial engineering, or equivalent, plus. 5+ years of experience as a Manufacturing Process Engineer, preferably in Medical Devices.
Experience using statistical analysis methods for process development and control, Minitab experience preferred.
Proven experience in chemical and process engineering.
Working knowledge of process engineering software such as SolidWork.
Experience in Lean Manufacturing - Six Sigma certification.
