
Openings
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Manufacturing Operations Manager - Medical Device/Pharma
The Manufacturing Operations Manager will be responsible for managing a production line to manufacture an ingestible microsensor with a pharmaceutical tablet and/ or capsule. A key initiative of this role will include scaling the manufacturing from pilot production to millions of units per day. This will require the integration of automated assembly equipment, MES, ERP, pharmaceutical quality systems, vendor management and cost control.
Responsibilities:
Scale assembly operation to meet clinical and business objectives
Implement pharmaceutical good manufacturing practice (cGMP) compliance
Maintain production metrics records for production line
IQ, OQ, and PQ validation of production equipment
Interface with Clinical, Regulatory, and R&D departments
Prepare and review department budgets and lead cost and efficiency improvement efforts within the operation
Develop, coach and mentor staff
Drive manufacturing strategy including outsourcing and/or OUS operations
Required skills:
Analog: transistor-level design – signal conditioning, signal processing, communications with an emphasis on very low power design (uA’s) and creative problem solving
A minimum of 5 years management experience in a manufacturing environment
Technical or operations experience in medical devices or pharmaceuticals
Experience in combination products (medical devices and pharmaceuticals) a strong plus
Proven results-oriented leadership and management experience
Demonstrated accomplishment in quantitative processing improvement: Six sigma, Lean manufacturing
A “get things done” attitude. Ability to mange a multi-disciplinary engineering team
Education:
Must have bachelors degree in EE, ME, ChemE or similar. Master’s degree preferred
Corporate benefits include: highly desirable salary, stock options, and medical benefits
If you are interested in joining Proteus, please email your resume to careers@proteusbiomed.com.
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