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Medical Device Mechanical Engineer
2 months ago
We are seeking a highly skilled Mechanical Engineer to join our team at ACL Digital. As a Mechanical Engineer for Combination Products, you will be responsible for designing and developing innovative solutions for our medical device products.
Key Responsibilities- Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
- Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
- Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
- Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
- Provide experienced support for investigations as well as new process development required to improve manufacturing operations.
- Coordinate test method development and delivery with selected contractors.
- Ensure that qualification parameters are met for product assembly requirements.
- Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
- Generate procedures necessary to support department and new process equipment.
- Provide experienced training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department.
- Participate in and assume responsibilities of team functions as assigned.
- Generate/author and be responsible for the Test Method documents.
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
- Excellent written and verbal communication skills
- Ability to work in a highly matrixed team environment
- 2 years of experience in the biotechnology/pharmaceutical industry
- 2 years of experience in equipment, method, and mechanical design
- Technical writing experience
- Experience with SolidWorks (or other 3D-CAD software)
- Experience with combination products and regulatory requirements
- Experience applying Minitab (or other statistical software packages)
- M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
ACL Digital is a leading provider of innovative solutions for the medical device industry. We are committed to delivering high-quality products and services that meet the needs of our customers.
