MAIN PURPOSE OF ROLE
Summarize the main purpose of the role.
Individual contributor with comprehensive knowledge in the specific area.
Ability to execute highly complex or specialized projects; adapts precedent and may make significant departures from traditional approaches to develop solutions.
Responsible for undertaking production activities.
Deals with complex queries escalated by production engineers and technicians so that the team meets established production specifications and schedules; volume, cost, and wastage targets; and quality standards.
**MAIN RESPONSIBILITIES**:
- Activities include setting-up, calibrating and operating machines and equipment, following production schedules and quality standards, monitoring production processes, and troubleshooting production problems.
- Control production activities, material flow, and inventory to achieve cost and quality targets and production schedules of the assigned production line(s), ensure compliance of standards.
- Monitors the performance and output of the team and re-assigns production tasks and inputs to ensure that production specifications and schedules; volume, cost, and wastage targets; and quality standards are met.
- Coaches and mentors less experienced engineers to help them use production equipment or resolve problems.
QUALIFICATIONS
**Bachelor's Degree.
STEM careers.
**
**7+ years of manufacturing/process development experience**:
- Statistical techniques knowledge (DOE, SPC) is required.
PE license is a plus.
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Willing to travel.
- Experience with continuous improvement methodologies.
Such as lean manufacturing techniques, value stream mapping, or similar.
- Knowledge of FDA, GMP, and ISO guidelines is required.
- Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.
- Experience in project management involving coordination of cross functional teams.
**Fully Bilingual (English and Spanish) / Required**
Preferred Qualifications & Education:
- 5 years prior experience in medical devices manufacturing.
- Performance management experience preferred