Job details

Biomedical Engineer

Job Title: EngineerLocation: Cambridge, MADuration: 24+ months Contract with potential extensionDescription: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 decisionsThis 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• 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 technologiesPreferred 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 PQPreferred 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 ProjectTop 3 Must Have Skill Sets:Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadershipMathematical background fundamentals of statisticsAbility to manage multiple, competing priorities simultaneously,

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$59K

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What You Should Know About Biomedical Engineer, Aditi Consulting

If you’re passionate about improving healthcare through technology, then a Biomedical Engineer role at our Thousand Oaks, CA facility could be your next big adventure! We're on the lookout for innovative thinkers who thrive in regulated environments and are excited to tackle engineering challenges head-on. As a Biomedical Engineer, you'll work alongside senior staff to design and deliver cutting-edge projects within the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Your responsibilities will include developing and managing Physical GMP Test Methods and integrated testing machines while ensuring all processes meet industry-leading standards. You’ll get to roll up your sleeves as you collaborate with other engineers to conduct experimental protocols, handle equipment validations, and perform lifecycle management. Your mathematical skills and knowledge of statistical analysis will be key as you turn data into insights and drive impactful decisions. If you have hands-on lab experience, CAD design skills in Solidworks, and a knack for automating systems, we want to hear from you! This is more than just a job; it's an opportunity for you to unleash your creativity and expertise to make a tangible difference in the medical field. Let’s work together to enhance the way technology informs healthcare decisions!

Frequently Asked Questions (FAQs) for Biomedical Engineer Role at Aditi Consulting

What are the main responsibilities of a Biomedical Engineer at the Thousand Oaks location?

As a Biomedical Engineer at our Thousand Oaks facility, your main responsibilities will include collaborating with senior engineers to initiate, design, and deliver projects. You'll develop and manage Physical GMP Test Methods, assist with integrated testing machines, and perform field evaluations of existing systems. Your role will also involve translating user requirements into technical documentation and executing engineering studies for automated test systems installations.