Description
Manufacturing and Process Development EngineerOVERALL RESPONSIBILTIES
- Supports manufacturing personnel and creates systems to aid in the production of multiple medical device families
- Support new product development through engagement with the R&D group and guides Design For Manufacturing activities in the early phases of projects
- Drives appropriate resolutions to manufacturing issues ensuring excellence in quality, cost and delivery
- Leads projects and engages with multiple teams members across all functional groups
- Identifies operational waste and institutionalizes systems to improve Core Operational Metrics - Throughput, Yield, Output, Productivity and Compliance
- Accurately applies statistics and sound logical thinking to evaluate and understand manufacturing processes and makes robust recommendations for improvements
- Communicates changes effectively to team members and capable of planning and executing those changes
- Is driven by data. Listens to the voice of the process and voice of the customer when assessing manufacturing system improvements.
- Coordinates the work of assigned technicians and engineers and takes responsibility for their results.
- Maintains accurate manufacturing documentation
- Continues to develop their knowledge of the medical device industry and keep up to date with manufacturing technologies
- Aligns systems throughout the product Value Stream to create value for all customers
- Focus on long term success by standardizing processes, eliminating variation and seeks perfection
- Provide technical support for root cause analysis, identifies corrective actions and implement effective controls
- Well versed in the implementation of Lean Principles and Six Sigma methodologies
- Creates risk assessments and implements controls to mitigate risks as they are identified
QUALIFICATIONS
- B.S. Degree in Engineering with 5+ years' experience, or an M.S. with 3+ years' experience
- Experience leading Process Validation efforts with new product process development in an FDA regulated manufacturing environment is highly desired. Experience in medical device field is extremely beneficial.
- Understanding of Nitinol, PTFE, or Catheter based Delivery Systems is preferred.
- The ability to successfully lead cross functional teams and understands the importance of team work.
- Fully engaged in the use of continuous improvement tools such as Visual management Systems, A3's, DFMA and 6-Sigma.
- Excellent analytical abilities and experienced with the use of Statistics to solve problems.
- Thorough understanding of SPC and the ability to use this information to eliminate variation.
- An individual who takes pride in their workmanship, relies on facts and data, and has constancy of purpose in their actions.
- Has initiative to meet or adjust deadlines and works effectively within a team environment.
PREFERRED KNOWLEDGE
- Experienced user of Statistical Process Control (SPC)
- Has created and interpreted research through the use Design of Experiments
- Performed Process Validation by creating and executing protocols, reports, testing and reviews
- In-Depth knowledge of 21 CFR Part 820 and regulatory requirements for Medical Devices
- ISO 13485:2003, Medical Devices and ISO 14971:2007, Medical Devices
- Worked with Quality Management Systems
- Application of Risk Management as it pertains to Medical Devices
- Implemented Design for Manufacturing/Assembly within new product development
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