Job Description:
Qualifications:
#zip
- Plan, implement, and manage engineering projects for automated assembly lines, including development, build, testing, commissioning, and validation.
- Manage complex automation engineering projects and new product development across multiple global sites
- Drive activities with equipment suppliers to ensure successful production start-up and scale-up.
- Lead design, planning, and sustaining of automated manufacturing systems.
- Ensure adherence to quality, regulatory, and corporate standards; report progress against timelines.
- Identify and escalate risks impacting project delivery, product quality, or safety.
- Interface with cross-functional teams including R&D, Quality, Regulatory, and Operations.
- Develop and implement innovative solutions and manage engineering changes.
- Conduct complex engineering studies, analyze data, and prepare technical reports.
- Create process documentation and technical procedures for medical device equipment.
- Perform root cause analysis and implement corrective actions for yield and cycle time issues.
Qualifications:
- Bachelor’s degree in Engineering/Manufacturing or related discipline.
- Minimum 5+ years of progressive technical experience; experience with automated manufacturing processes preferred.
- Prior experience in medical device or pharmaceutical environments (FDA/cGMP/ISO regulated).
- Strong knowledge of automation systems, validation lifecycles, and high-volume manufacturing lines.
- Excellent project management, communication, and problem-solving skills.
- Ability to work independently and in a fast-paced, team-oriented environment.
#zip