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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
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