Engineer

Overview Job Title: Engineer (JP12205C) • Location: Cambridge, MA. OR Thousand Oaks, CA. • Business Unit: Physical Methods Development, Modeling and Emerging Methods • Employment Type: Contract • Duration: 2+ years (with possible extensions) • Rate: $38 - $42 • Posting Date: 1/26/2024 • Notes: Only qualified candidates need apply. Job Description 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. Candidate Profile 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 client 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 Required Qualifications 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 in a lab. Top 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, Day to Day Responsibilities Develop and support lifecycle management of physical test methods and associated documentation (test method protocols, SOPs, training documents, etc.) Execute test method protocols, analyze data Maintain project status and communicate with client internal clients 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 Preferred Qualifications 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 Why is the Position Open? Supplement additional workload on team Red Flags Is not local and cannot commit to onsite work. No Bachelors. Not a document review role, not interested in candidates with background in QC or QA experience only. No interested in lab work setting. Interview Process One phone and one virtual panel interview. Application We invite qualified candidates to send your resume to View email address on click.appcast.io. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr