As the Sr. Director, Manufacturing Technical Operations you will be responsible for the direction and coordination of Manufacturing Technical Operations functions, including manufacturing engineering, process engineering, equipment engineering, and automation functions. This leader will have an excellent understanding of device manufacturing, including working with device development and manufacturing to enable manufacturing at various scales. This leader will foster a strong attitude of collaboration and work closely with all other groups within the organization. This person will provide leadership and oversight to a variety groups within the operations division, including manufacturing and supply chain, in support of commercial product efforts.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Ownership of designing, sustaining and improving manufacturing processes with a critical focus on improving yield and gross margin.
- Work with colleagues across GenMark to ensure efficient and effective production for all product lines.
- Serve as Subject Matter Expert on device manufacturing; supporting development, manufacturing, investigations, process improvements, validations, regulatory filings, technical documents, and inspections.
- Work with suppliers and contract manufacturers on tech transfer, process installation, process qualification, and ongoing manufacturing oversight.
- Lead a team of technical experts to support manufacturing and translate business requirements into process changes in support of product and manufacturing strategies.
- Ensure ongoing technical support for all manufacturing processes both internally and/or at contract manufacturing sites and directing global initiatives and cross-functional teams of subject matter experts in manufacturing.
- Driving innovation and communication of latest industry trends and best practices for process design and manufacturing to ensure consistency.
- Minimum of BS degree with a scientific or engineering focus
- 10+ years of operational or engineering experience in a Biotechnology, Medical Device or Pharmaceutical manufacturing environment.
- Demonstrated knowledge of biomaterials and biotechnology device manufacturing.
- Experience establishing and maintaining robust validation and process control strategies.
- Several years leading and managing a team of dedicated engineers, scientists and technicians.
- Strong engineering skills, including facility fit and process engineering assessment into different facilities.
- Strong Lean Six Sigma or alternate continuous improvement skills for root cause analysis.
- An understanding of design control elements required for medical or in-vitro diagnostics devices.
- Able to apply principles of mechanics, microfluidics, and materials to understand the mechanical design of complex plastic parts and assemblies.
- Able to apply basic biologic principles including nucleic acid sample preparation and PCR amplification to understand assay performance on the consumable platform.
- Experience with plastic assembly techniques such as ultrasonic and laser welding.
- Advanced experience with root cause analysis, design of experiments, and data analysis.
- Experience with qualification, verification, and validation requirements as related to parts, equipment and products.