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Biomedical Engineer
1 month ago
- Ideal candidate:
3 YOE in field desired with bachelors.
- Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired.
- Mathematical background fundamentals of statistics.
- Useful to have exposure to test method development, CAD design, Solidworks, mechanical modeling.
- Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.
- Job Details:
- Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization.
- Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods.
- The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation.
- Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
- The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology.
- The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
- This may include, but is not limited to, the following:
- Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
- Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
- Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
- Developing, enhancing, automating, and managing test data
- Network with manufacturing and quality organizations
- Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
- Monitoring technological developments in the field & evaluation of new technologies
