Mechanical Engineer
3 weeks ago
Job Title: Mechanical Medical Device Engineer
Location: Cambridge, MA
Duration: 2 years
Description:
ONSITE ONLY - supporting Cambridge,
Top 3 Must Have Skill Sets:
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Ability to manage multiple, competing priorities simultaneously
Statistical analysis, and knowledge of Gage R&R,
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 internal to Amgen
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
Preferred Skills
Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ
Preferred Traits:
Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project
Basic Qualifications
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
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