Test / Senior Test Engineer - Medical Devices

Posted 01 August 2023
Salary Negotiable
LocationUnited States of America
Job type Full Time
DisciplineMedical Devices
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.


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.