What are the responsibilities and job description for the LCE Project Manager position at Sciprex?
Job Description:
Required Skills:
- Experience in Life Cycle Engineering with project management
- Experience in a medical device industry or other regulated environment
- Experience with electromechanical design, component manufacture, general engineering, and system testing
- Experience in project management and execution of small and mid-scale projects ($50k-$500K budgets)
- Demonstrable experience with external suppliers of plastics, metal, and electrical components
- Demonstrable experience with manufacturing and assembly of medical devices or similar commercial products
- Ability to manage the supplier’s offshore resources
- Lead Design and Development activities relating to life cycle engineering projects of Medical Devices
- Lead Design Control and documentation across the life cycle of the product
- Lead Design Change activities to Mitigate Product Complaints
- Execute CAD Drawing and Modeling as per the Project Scope
- Act as subject matter expert for all CR’s and CN’s
- Experience in writing IQ / OQ / PQ, Test Method Validation protocols and reports.
- Lead Design verification testing including Developing Test matrix, conducting the required engineering tests and report generation
- Draft and review documentation/Protocol related to procedures, special instruction & reports etc.
- Experience in leading self-directed work teams
- Ability to understanding of surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system / regulatory environment
- Project Management certification (e.g., FPX or PMP) preferred
- Ability to work in ambiguity, prioritize and lead work, and demonstrate ability to independently judge, define, and manage risk in development of manufacturing solutions for our endo-mechanical platform
- Work one-on-one with customer stakeholders to identify procedure and/or product opportunities and evaluate potential technical solutions
- Provide innovative product, system & component design solutions
- Understanding of cGMP, Good Documentation Practices, and Regulations
Should you be interested, please send me a copy of your resume in word format along with the following details ASAP.
Salary : $50,000 - $500,000