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)
Preferred:
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
SolidWorks
Skills & Competencies:
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
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
Physical Requirements:
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.
RESPONSIBILITIES:
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 challenge equipment performance against intended specifications
Execute protocols and write validation reports
Process Validation to meet regulatory requirements which includes writing protocols, execution of the protocol, and writing the validation report
Standard Operating Procedures creation, revision and implementation including necessary change order, training and verification activities
Test Methods write and execute test method validations such as Gauge R&R studies
Project Management prepares overall project proposals including cost estimates and schedules for designated projects
Assign priority and schedule tasks to provide timely solutions to achieve results
Participate as a member of or facilitate cross functional teams
Support troubleshooting equipment downtime and identifying short term and long-term repairs/ short stop mitigations
Applyengineering principles and methods to understand and provide solutions to complex technical challenges
Continuously evaluate team performance and processes to identify opportunities for improvement and increased effectiveness
