Process Development Engineering Team Lead

Description

Job Summary

The Process Development Team Lead position leads the development, improvements and implementation of optimal and compliant manufacturing processes in accordance with product specifications and quality standards. The Team Lead is responsible for guiding the technical efforts and deliverable execution of direct report’s efforts. 

Essential Functions 

• Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and finished good devices.
• Guides the technical efforts and deliverable execution (not the human resource efforts of performance or career development) of 4 or more engineers and technicians.
• Acts as the liaison between development and operations.
• Advocates for the process to ensure they are repeatable and can capably produce product that meets the design requirements.
• Prepares and presents detailed plans necessary to complete assigned projects.  
• Develops schedule milestones, coordinates resources, facility and equipment for assigned projects. 
• Assists in improving the system of production controls, standard operating procedures, safety, quality control and training. 
• Prepares and maintains detailed layouts of buildings and equipment. 
• Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results. 
• Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis. 
• Performs product/process analysis for production and quality metrics. 
• Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials.
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements. 
• Recommend, support and implement improvements, modifications, or additions that will improve work processes.
• Take the lead in analyzing the need for new process development and to meet company needs including specifying, ordering, installing and validating new equipment or processes.
• Prepare justification for capital expenditures.
• Aid in production transfers from R&D to manufacturing.
• Propose potential new manufacturing technologies, including automation and new equipment.
• Contribute to the definition, development and implementation of LEAN manufacturing initiatives.

Requirements

Education, Experience, Required Skills 

• Bachelor’s degree in engineering or related field  
• 10+ years related experience in medical device industry with a focus in Process Development 
• Demonstrated ability to independently develop medical device manufacturing processes from concept to production. 
• Experience with medical device Design For Manufacturing, design control, quality systems and product development phases
• Demonstrated ability to implement change in a way that positively impacts overall department and company performance
• Must be able to handle multiple projects simultaneously
• Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
• Experience using influence to affect project and organizational success
• Experience with programs including SolidWorks and/or Mastercam 
• MS Office Proficiency  
• Ability to handle and be trusted with confidential and/or sensitive information

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer. 
• Must be able to lift up to 25 pounds at times. 
• Must have excellent hand-eye coordination.
• Ability to differentiate between colored wires, tabs, and electronic components.
• Must wear gown, gloves, and ear protection if applicable.