Process Engineer
24 hours ago
Job Summary:
Enable Injections Inc is seeking a highly motivated Senior Process Engineer to join our manufacturing team. As a key member of our team, you will drive process improvements, lead cross-functional teams, and ensure compliance with regulatory requirements.
Key Responsibilities:
- Manufacturing Support: Respond rapidly to downtime events, determine corrective actions, and implement improvements.
- Continuous Improvement: Identify opportunities to improve yield, throughput, and labor efficiency, and lead implementation efforts.
- Quality System Documentation: Author quality system documents, including nonconformance reports, CAPA plans, and change controls.
- Root Cause Investigations: Lead product/process/equipment root cause investigations with a cross-functional team and determine scrap root causes.
- Production Model: Create and maintain the labor/capacity/yield production model for manufacturing lines.
- Engineering Builds: Lead equipment/process development engineering builds and tests, write protocols, and summarize activity in engineering reports.
- Training: Train manufacturing operators.
- Layout/Workflow: Optimize layouts and workflows using lean methodologies.
- Other duties as assigned.
Requirements:
- Bachelor's Degree in a technical discipline (e.g., Engineering or Science) and/or education/experience equivalent.
- A minimum of 6 years of experience in FDA-regulated manufacturing and/or process/equipment/product development.
- Strong 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 in a high-volume FDA-regulated commercial manufacturing environment.
Benefits:
We offer a competitive salary range of $120,000 - $150,000 per year, depending on location and experience, and a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
About Us:
Enable Injections Inc is a leader in the medical device industry, committed to delivering innovative solutions that improve patient outcomes. Our team is passionate about developing and manufacturing high-quality products that meet the highest standards of excellence.
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