Process Engineer

Company: Kelly Services
Location: Herndon
Posted on: April 9, 2021

Job Description:

Process EngineerGaithersburg, MDUp to 50 an hour8 month contract--Main Duties and Responsibilities:--- The successful candidate will serve as a core team member of cross-functional combination product pilot line team responsible for building design verification samples.--- He/she will be responsible for the technical aspects and implementation of a pilot line that builds new combination products including fill/finish and assemble/pack/label processes.--- He/she will complete material handling and process development and assemble builds of design verification samples--- He/she will author and review appropriate documentation for Design Verification sample builds are completed with traceability and quality approval--- He/she will work on complex and technically demanding process development where analysis of data may require an evaluation of multiple variables--- He/she will work in a collaborative matrix structure and interact with co-workers across different functional groups within research and development, regulatory affairs, quality and operations--- He/she will be able to perform process risk assessmentsEssential Requirements Process/Device Engineer:Education and Experience: BS or equivalent in Mechanical, Biomedical or related engineering background with at least 5 years relevant industry experience, MS or equivalent with at least 2 years relevant experienceRelevant Experience:The candidate must have background in Medical Device and/or drug-device combination product development and be familiar with US and EU regulations. Must have technical experience with common tools and methods used for process development, such as DOE, pFMEA, equipment qualification, process validation and production batch records as examples. Candidate must have experience working in cross-functional matrix teams.Other Requirements:--- The ability to author and follow SOPs, policies, and regulations--- Great teamwork and communication skills, both oral and written, are critical. Good prioritization, time management, and organizational skills are required.--- Experience writing technical documents such as procedures and reportsDesirable Skills and Experience:--- Experienced in Solidworks 3D CAD--- Understanding of other disciplines within biological process development and research--- Experience using statistical modeling and DoE--- Experience in commonly used manufacturing methods, such as fixture development, injection molding and automated assembly conceptsWhy Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Germantown , Process Engineer, Other , Herndon, Maryland