Manager, Manufacturing Engineering

Title:

Manager, Manufacturing Engineering

Description:

Location: Onsite

Status Type: Full Time

• Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or education/experience equivalent
• A minimum of 10 years of experience in process design and development to support new product development
• Experience leading cross functional teams, projects, and/or direct reports
• Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing
• Experience with Product DFMA (Design for Manufacturing and Assembly)

• Experience in a high-volume manufacturing environment preferred, i.e. production 1M+ annual
• Experience with custom equipment design, procurement and qualification such as via the GAMP process
• Experience in reviewing production floor/ equipment downtime, including troubleshooting and identifying robust corrective actions, equipment continuous improvement
• Experience programming vision systems, robotics, and PLC
• Six Sigma Green Belt (or higher) Certification (CSSGB)
• Excel and Minitab
• Solid Works

• Strong leadership with the ability to create a vision, energize the team, and motivate employees to strive toward that vision
• Demonstrated “can-do” attitude with the ability to remain composed, constructive, and forward-focused in high-pressure or ambiguous situations
• High level of ownership and accountability—drives issues to closure and ensures commitments are met
• Proactive problem-solver who anticipates risks and addresses them before they impact operations
• Proficient with spreadsheet and statistical analysis software packages
• Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings
• Ability to create experimental designs and collect, interpret, and analyze data using statistical techniques
• Strong technical writing skills (planning, protocol writing, execution, report writing)
• Demonstrate understanding of medical device product development including risk management methodologies
• Knowledge of PLC and HMI programming for equipment troubleshooting or minor modifications (Allen Bradley)
• Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ)
• Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipment troubleshooting
• Strong analytical and creative problem-solving skills, able to provide solutions to complex technical challenges
• Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
• Communicate effectively through both verbal presentation and technical writing to various internal stakeholders of varying technical abilities
• Demonstrated ability to prioritize tasks and manage a varied workload to meet team objectives
• Demonstrated coaching, mentoring and development of direct reports
• Ability to develop and manage project timelines to drive completion of projects and goals in a timely manner

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

• Lead and develop direct reports such as manufacturing engineers; set clear expectations, provide regular feedback, and cultivate a high-performance, accountable team culture
• Model and reinforce a positive, action-oriented attitude that encourages ownership, collaboration, and constructive problem-solving
• Lead the design and development of manufacturing processes, including equipment specification, design, development, construction, implementation and modification.
• Review and Approval of manufacturing process documentation, drawings, NCR’s, CAPA’s and other quality documents
• Creation of manufacturing process and equipment development documentation
• Equipment Qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements
• Create test protocols to…