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Mechanical Biomedical Engineers-Global Transfer

Company: Kelly Science, Engineering, Technology & Telec
Location: raynham
Posted on: May 3, 2021

Job Description:

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 sick/personal time.


Mechanical Biomedical Engineersshould 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 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 Site).
  • 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 desired.
  • Spanish and/or French fluency a nice to have.
  • 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.

Qualifications

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  • 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 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 is preferred.
  • 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.



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/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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