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