Test / Senior Test Engineer - Medical Devices

Posted 01 August 2023
Salary Negotiable
LocationUnited States of America
Job type Full Time
DisciplineMedical Devices
ReferenceBBBH1041_1690898420
Contact NameCarl Gbolade

Job description

Mantell Associates is currently partnered with the most innovative medical device company on an exciting opportunity and is in search for a Senior Engineering Manager.

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Senior Engineering Manager - Responsibilities:

  • Lead and manage a team of validation engineers to ensure timely and compliant execution of validation activities

  • Develop and implement validation strategies and master plans for new and existing manufacturing processes and equipment

  • Oversee the qualification and validation of equipment, utilities, and systems, ensuring compliance with regulatory requirements and internal standards

  • Collaborate with cross-functional teams, including quality assurance, engineering, and manufacturing, to ensure validation activities are integrated seamlessly into the project lifecycle

  • Develop and maintain validation protocols, reports, and standard operating procedures (SOPs)

  • Perform risk assessments and impact assessments to identify critical parameters and ensure appropriate controls are in place


Senior Engineering Manager - Requirements:

  • Bachelor's or advanced degree in engineering or a related scientific discipline

  • In-depth knowledge of validation principles, practices, and regulatory requirements (FDA, EMA, ICH)

  • Strong leadership and team management skills, with the ability to mentor and develop a team of validation professionals

  • Experience in medical devices, knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other medical device industry experience

  • Strong problem-solving and decision-making abilities, with a focus on continuous improvement


Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.