Description
Serve as manufacturing engineer for scale-up and transfer of stent implant device from start-up facility to large facility. Follow developed project schedule.Responsible for evaluation of process capability of stent implant manufacturing line and develop highly capable manufacturing processes for existing products. Design and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)Create and maintain the documentation necessary to ensure the consistent manufacture of products (processes, drawings and shop floor paperwork)Develop and execute process characterization, validation and material qualification plans
Maintain current production processes and assist in smooth transfer of new processes into the production line.Apply fundamental engineering principles to create practical solutions to technical challenges and provide technical support across functionsPerform root cause analysis and develop corrective and preventative actions for quality systems and productionWork closely with all relevant stakeholders as required and report on progress of project by means of weekly report outs to management. Deliver on tasks on time per schedule.Coordinate staged moves with Production Managers, Engineering Teams, Facilities and Project Team that minimizes disruption to production schedule and ensures compliance during transition.Apply lean manufacturing methods to cut product cycle time and costsComply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
PREFERRED QUALIFICATIONS
- Experience in fixture and equipment design and validation specifically with processes related to stents.
- Manufacturing production experience
- Minimum of 2 years in a medical device manufacturing / process development role.
QUALIFICATIONS GUIDELINES:
Any combination equivalent to, but not limited to, the following:
- Bachelor's degree in Biomedical Engineering, Material or Mechanical Engineering or similar field with 2-4+ years direct experience is required
- Experience with equipment and tooling design and validation
- Experience developing innovative new processing technologies
- Understanding of design and process FMECA, 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
