QUALIFICATIONS

Required:

• Bachelor’s Degree in a technical discipline (e.g., Engineering or Science) and/or education/experience equivalent
• A minimum of 8 years of experience in process/equipment design and development to support new product development and manufacturing
• 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, cycle time < 1 second
• Experience with custom equipment procurement and qualification such as via the GAMP process

Skills & Competencies:

• Leadership – ability to create a vision and motivate employees to strive to create that vision
• Attention to detail
• Strong influencing and negotiating skills
• Excellent verbal communication and technical writing skills
• Proficient with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
• 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
• Experience with the validation life cycle (planning, protocol writing, execution, report writing)
• Understanding and application of Good Automated Manufacturing Practice (GAMP)
• Proficient with the MS Office Suite (Word, PowerPoint, Excel, Visio)

Physical Requirements:

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

RESPONSIBILITIES:

• Lead direct reports such as manufacturing engineers
• Delegate and prioritize tasks to align with corporate strategies
• Lead the design and development of manufacturing processes and equipment
• Review and approve manufacturing process documentation
• Creation of manufacturing process 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
• Write protocols, execution of the protocol, and write the validation report
• Standard operating procedures create, revise, and implement including necessary change order, training, and verification activities
• Test methods, write and execute test method validations such as Gauge R&R studies
• Project management, prepare overall project proposals including cost estimates and schedule for designated projects
• Assign priority and schedule tasks to provide timely solutions to achieve results
• Participate in cross functional teams
• Other duties as assigned