Mechanical Biomedical Engineers-Global Transfer

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).

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