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Cook Group
Cook Group
11 – 50 Employees
ConsultingHealthcareLogistics
Cook Group is a family-owned network of entrepreneurial companies rooted in medical devices and healthcare. Based in Indiana with operations spanning a global footprint, the organization works across life sciences, property management, resorts, services, consulting, and logistics. Its businesses are guided by integrity, quality, respect, and transparency, with an emphasis on developing practical solutions for employees, customers, and the communities they serve.
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Post-Market Engineer II - Medical Devices

Support the post-market lifecycle of implantable medical devices for Cook Medical Australia. Lead design controls, risk management, CAPAs, regulatory documentation, and engineering projects.

AUAustraliaOn-siteContractMiddleSeniorEnglish RequiredEngineer

Description

  • Lead or support post-market activities for current products
  • Maintain medical device designs in line with current standards, including design changes, testing, and risk management
  • Prepare documentation for regulatory submissions and responses to authorities
  • Lead or assist with Corrective and Preventive Actions (CAPAs)
  • Support engineering projects and programs, including applicable post-market work with external contractors
  • Lead or assist in assessing design-related supplier changes
  • Collaborate professionally and effectively across all levels of the global organization
  • Report to the Team Leader, Post-Market Engineering

Requirements

  • A tertiary qualification in mechanical engineering, biomedical engineering, or an equivalent field is essential
  • Practical knowledge and experience applying design controls is essential
  • Previous experience in a highly regulated industry is required, preferably in medical devices
  • Practical knowledge and experience applying risk management methods is essential
  • Strong technical writing ability and careful attention to detail
  • Experience managing work across multiple projects and disciplines
  • Effective time-management and communication skills
  • Intermediate statistical data analysis skills and experience are desirable

Benefits

  • Employment stability with an established company
  • Recognition awards celebrating employee contributions
  • Competitive annual salary
  • Annual leave loading
  • Quarterly bonus linked to manufacturing metrics
  • Subsidised cafeteria and supportive working conditions
  • Continued training, development, and professional support
  • An inclusive culture that values its employees

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