Knowledgeable in troubleshooting and support of high volume liquid filling either in formulation or fill within a medical device environment
- Evaluate mechanical situations that could lead to non-conforming material and conduct evaluation and suggest and implement methods to prevent reoccurrence.
- Lead investigations and troubleshooting activities to minimize nonconforming materials and optimize production efficiency
- Review engineering design files (CAD drawings, technical specifications, component spec sheets, etc.) for accuracy and manufacturability
- Design or justify new equipment (fixtures, gages, semi-automatic machines, automatic machines, etc.) and processes for new and existing products.
- Create and execute process validations and capability studies.
- Create, review, and maintain SOPs and Work Instructions.
- Travel up to 10% both domestic and international.
- Special manufacturing projects, and other duties as assigned
- Bachelor's Degree in Engineering/ Scientific field with minimum of 7 years’ industry experience in related industry required.
- Master's Degree in Engineering is highly desirable.
- Proven expertise in usage of MS Office Suite, Solid Works or equivalent, Computer Aided Design (CAD) or ProE experience preferred.
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
- Previous experience working with lab/industrial equipment required.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Strong problem-solving, organizational, analytical, and critical thinking skills.
- Knowledge of filtration, formulation, automation, machining, and fabrication processes preferred.
- Experience with lean principles, six sigma, and GMP required
- Experience with a ERP system, SAP preferred
- Experience working within a medical device or highly regulated environment required
- Broad knowledge of manufacturing processes, large capex projects, and assembly fixture development.