Supports the Urologix products to ensure Manufacturing Operations core metrics are successfully achieved. Provides technical leadership; leads implementation of manufacturing improvements and provides floor support to assigned product lines. Works with Urologix Quality dept and supply chain to complete change requests, risk mitigation projects and supplier related cost savings initiatives.
- Identify, justify and implement data driven projects to reduce manufacturing costs. Apply lean manufacturing methods.
- Provide input and guidance on establishing visual, dimensional and performance requirements for inspection of components, in process assemblies and finished products.
- Perform product analysis and failure analysis when needed along with trend analysis of customer feedback
- Work collaboratively in a cross functional team to author and (or) provide input on PFMEA/Risk management documentation
- Support supplier quality approval and monitoring along with supporting alternate sourcing and long-term supply chain strategy development
- Design and qualify new processes, tooling & equipment (IQ/OQ/PQ)
- Develop highly capable manufacturing processes for existing products
- Create and maintain the documentation necessary to ensure the consistent manufacture of products. Support the development of training materials for new manufacturing operators
- Maintain current production processes and assist in smooth transfer of new processes onto the production line.
- Apply fundamental engineering principles to create practical solutions to technical challenges and provide technical support across functions
- Perform root cause analysis, develop corrective and preventative actions for manufacturing process and product related issues.
- Create drawing/specifications to support purchasing and inspection of incoming items.
- Bachelor’s degree in Biomedical Engineering, Material or Mechanical Engineering or similar field with 6+ years direct medical device experience is required
- Experience with equipment and tooling design and validation
- Experience developing innovative new processing technologies for medical devices
- Understanding of design and process FMEA, process validation and variability reduction applications.
- Application of statistical and analytical methods such as SPC, SQC and DOE
- Process background (development, capability, optimization, validation) with a regulated industry.
- Test protocol generation, execution and reporting
- Plant/Manufacturing experience
- Supervisory experience of technicians and direct hourly personnel
- Strong oral and written communications skills
- Demonstrated knowledge of advanced engineering and analysis methods for process and design improvement
- Technical understanding of material properties utilized in high reliability, small tolerance products and components
- Experience along the continuum of the product lifecycle
- Experience with ISO 13485, ISO 14971, and MDD, FDR regulations
- Strong computer skills, including Microsoft Word, Microsoft Excel, Microsoft Project, Solidworks, Minitab, etc.
- Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports.
- Working knowledge of GMP and ISO regulations.
- Comply with applicable FDA and international regulatory laws/standards.
- Must be able to work in a dynamic environment with little supervision or daily direction.
- Strong, team-oriented professional with good interpersonal skills and project management experience.