Mechanical Medical Device Engineer
Company: Kelly Services
Posted on: April 9, 2021
Kelly Outsourcing & Consulting Group (KellyOCG), a managed
solution provider and business unit of Kelly Services, Inc., is
currently seeking a Sr. Mechanical Engineer for a long-term
engagement at one of our Global clients in Raynham, MA.-- This role
is a full-time, fully benefitted position.---- As a KellyOCG
employee you will be eligible for Medical, Dental, 401K and a
variety of other benefits to choose from.---- You'll also be
eligible for paid time off, including holiday, vacation and
sick/personal time.--All KellyOCG employees receive annual
performance reviews.-- Sr. Mechanical Engineer --- should excel in
a medical device environment that embraces teamwork, change,
risk-based decision-making and flexibility. This individual will
work in a team setting to provide leadership and support throughout
the product lifecycle. This individual should be willing to make a
significant contribution to a multi-disciplinary team, must be
self-motivated and have excellent written and verbal communication
skills.-- Working in a team setting, this individual's major
responsibilities will be as follows (but not limited to):
- Support legacy products and design through design control
- Learn surgical procedures and map the product solutions into
potential areas of risk and liability.
- Support and conduct process verification and validation
- Conduct and lead process/design/procedural failure mode effects
- Develop risk assessment, inspection methodology and acceptance
criteria for inspection sample plans and conduct audits of new
suppliers as part of the project teams.
- Conduct audits of new suppliers as part of the new product
development project teams
- Support maintenance of existing products including but not
limited to design changes, process changes, supplier changes,
remediation, recertification and brand extensions.
- Experience with Corrective & Preventive Actions, Nonconforming
Materials, Risk Management, etc.
- Provides leadership in the understanding of Medical Device (21
CFR 820) regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as
cross functionally with departments such as R&D, Regulatory,
Manufacturing, and Marketing.--Qualifications
- A minimum of a Bachelor's degree in a Scientific discipline is
required. (Mechanical or BioMedical degree/experience) An advanced
degree in a related field is an asset.
- Excellent problem solving and decision-making skills will be
required. Interpersonal skills that foster conflict resolution as
it relates to technical situations will be required.
- A minimum of 7 years of work experience in the Medical Device
industry is preferred. Bilingual English / Spanish desired
- Experience with DHF files is required. Also experience with
Global Transfers is required.--
- Experience working around or with clean room assembly
experience with Orthopdics Electrical or electromechanical
- Advanced Technical Training in Quality Engineering principles,
Risk Management, Product Testing, and Sports Medicine is
- Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and any
other specific product standard is an asset.
- Experience conducting Process / Design Failure Mode Effects and
Analysis is required.
- Experience leading Process Verification / Validation activities
- Experience with Blueprint reading/literacy including GD&T
is preferred. Familiarity with inspection methods and techniques is
- Process Excellence/Lean experience is preferred.
- This position will be based in Raynham, MA.----Important
information:--This position is recruited for by a remote Kelly
office, not your local Kelly branch. --Applicants must be legally
permitted to work in the United States immediately and without
employer sponsorship.(F1 OPT/H1B--cannot be considered for this
position).--Why 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, Brockton , Mechanical Medical Device Engineer, Engineering , Raynham, Massachusetts
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