Mechanical Biomedical Engineers-Global Transfer
Company: Kelly Science, Engineering, Technology & Telec
Posted on: May 3, 2021
Kelly Engineering is currently seeking
several Mechanical Biomedical Engineers
for long-term remote and
onsite engagements at one of our Global
clients in Raynham, MA.
These are full-time, fully benefitted positions.As a Kelly
Engineer employee you will be eligible for Medical, Dental, 401K,
and a variety of other benefits to choose from.Youll also be
eligible for paid time off, including holiday, vacation, and
Engineersshould excel in a
medical device environment that embraces teamwork,
change, risk-based decision-making, and
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 individuals major responsibilities will be as follows
(but not limited to):
- Senior, mid, and Jr levels for Manufacturing
Transfer R&D support positions (Europe site going to Mexico
- Will be remediating input/output matrices and
identifying and coordinating testing program (tests to validate the
manufacture of devices in a new location).
- Familiarity with cleanroom assembly
- Spanish and/or French fluency a nice to
- Prior R&D document remediation and Product
transfer experience highly desirable.
- Not looking for a manager, some management
experience would be a plus as this project will involve lots of
people and personalities.
- 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.
- 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.
- 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
- 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 4-7 years of work experience in the Medical
Device industry. Bilingual English / Spanish desired
- Experience with DHF files is required. Also,
experience with Global Transfers is required
- Advanced Technical Training in Quality Engineering
principles, Risk Management, Product Testing, and Sports Medicine
- 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 is required.
- Experience with Blueprint reading/literacy including
GD&T is preferred. Familiarity with inspection methods and
techniques is an asset.
- Process Excellence/Lean experience is preferred.
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
(F1 OPT/H1Bcannot be
considered for this position).
Keywords: Kelly Science, Engineering, Technology & Telec, Brockton , Mechanical Biomedical Engineers-Global Transfer, Other , raynham, Massachusetts
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