MANUFACTURING PROJECT ENGINEER
Creganna-Tactx Medical is seeking an innovative, knowledgeable and highly versatile Manufacturing Project Engineer. The right candidate will be able to adapt quickly to changing priorities and manage multiple projects simultaneously while ensuring that every product and service we supply conforms to FDA QSR, ISO 13485 and MDD standards.
Creganna-Tactx Medical serves medical device and life science companies, specializing in products, technologies and solutions for minimally invasive therapies. We are the partner of choice for the world’s leading medical device companies.
Creganna-Tactx Medical provides: a competitive salary, a comprehensive benefit package, 100% employer paid life and long term disability insurance, 401k, bonus potential and educational reimbursement (12k per year).
The Manufacturing Project Engineer (MPE) will have direct responsibility for the Manufacturing project management system including facilitating team meetings, updating progress, managing the critical path of assigned projects, author supporting validation and protocol documentation in compliance to the internal requirements and external regulations and standards assist the Director of Operations in resource management and contribute to achieving other departmental objectives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Organize, manage and direct project team tasks and assures proper application of Design Control standards, tools and methodologies in project work
- Delivers full project objectives on time and on budget
- Design and develop tooling, equipment, functional drawings and fixtures for new and existing products to improve quality, cost and productivity
- Evaluate processes to identify areas to improve quality, cost efficiency and employee safety,
- Interface daily with in-house and customer engineering teams to identify/resolve problems and implement solutions to stabilize product, including diagnosing, troubleshooting, and resolving equipment down situations
- Evaluate processes and technologies for reliability, capability, consistency and cost effectiveness
- Write validation protocols for manufacturing equipment and processes; evaluate data
- Assist in project transfer activities of products
- Excellent technical writing ability - Protocols and reports for product testing, test method validations, process development, DOEs, customer quotations and proposals,
- Supports process development needs of New Product Development projects, including championing Design for Manufacturing and Assembly (DFMA) initiatives on new product designs
- Knowledge of FDA regulated medical device manufacturing requirements, QSR, cGMP, ISO standard; experience with introduction of new products, and development of new manufacturing processes
- Knowledge of Class II and Class III interventional devices and implantables
- Interface with suppliers to improve or resolve quality issues
- Identify and implement improvements to promote product quality and manufacturability
- Bachelor's Degree in a Mechanical Engineering
- 3 to 5 years of experience in medical device industry with emphasis on project management
- Proven track record in successful project management in commercial phase; must be able to manage multiple projects at the same time
- Excellent communication/report writing skills
- Working knowledge of FDA Quality System Regulation, ISO 13485/9001
- Excellent time management skills
- Must demonstrate the ability to set and meet deadlines
- Demonstrated technical proficiency, independent thought and collaboration with others
- Ability to read and interpret drawings and design specifications
- Excellent technical writing skills and verbal communication