Job Description
Product Development on a Injected Molded disposable medical device
Primary Responsibilities
• Ensure manufacturing processes are in conformance with ISO and FDA guidelines.
• Support/lead programs for cycle time/cost reductions, safety initiatives and quality improvements.
• Establish controls for manufacturing to ensure repeatability and quality of process outputs.
• Research, source, and specify equipment as it relates to manufacturing processes.
• Generate equipment specifications and equipment acceptance criteria.
• Provide Design for Manufacturing/Design for Test (DFx) guidance for incorporating into designs.
• Interface with R&D and marketing to effect product design changes that aid manufacturing.
• Plan, author and execute process validations and equipment qualifications.
• Troubleshoot and resolve manufacturing process issues via clear and rational root cause analysis.
• Provide guidance and training to less experienced engineers for CAPA and complaint handling.
• Provide manufacturing direction and guidance to R&D, QA engineers and technicians.
• Perform lead role in transitioning new designs into manufacturing
• Creates project plans and organizes resources to ensure project milestones and costs are met
• Provide training to production personnel on manufacturing processes.
• Revise and improve SOP’s.
Knowledge, Experience and Education Requirements
• Bachelor’s Degree or equivalent, in a technical field; with Manufacturing, Mechanical, Electrical, or Industrial engineering degrees preferred.
• 7-10 years related experience with a wide range of engineering, design, and computer skills.
• Thorough knowledge of FDA Quality System Regulations and ISO Quality Systems Requirements.
• Leadership skills to teach, train, and lead others in the manufacturing process.
• Expertise with SPC, Experimental Design and Statistical Sampling techniques.
• Advanced SolidWorks capability is preferred.
• Fabrication skills are preferred.
• Aptitude for leading/managing people is preferred (career growth).-
BSME, Process Development, Medical Devices
Tewksbury MA: Sr Manufacturing / Process Engineers (MEDICAL DEVICES / ONSITE) (232666)
