Manager, TruDi(R) Calibration Systems

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

We are seeking an experienced Manager to lead the team responsible for the development, life cycle management, and global service support of Testers and Calibration (T&C) systems used in the manufacture of TruDi Navigation Systems and related products. This role is critical for ensuring the effective management of all T&C systems, providing strategic direction, and aligning resources to meet both internal and external customer needs.

Key Responsabilities

New Product Development for T&C systems

• End to end responsibility for the development of new Testers and Calibration systems, from receiving the requirements from the customers, until the system is released and installed
  
  

• Responsible for all Eng. and project activities supporting the Life Cycle of the testers & Calibration systems, including EOL management
• Technical support for improvements, investigations and problem solving
  
  

• Support all TruDi manufacturing sites for T&C systems
• Install base management for all Testers & Calibration systems worldwide
• Install base data control and data management systems
• Configuration control
  
  

• Responsible for the execution of all projects managed by the team
• Leading project teams / core teams as required
• Build project plans, budget and timelines. Track and meet milestones
• Lead project meeting, action items, resources management, and supplier issues.
  
  

• Build commercial relations with Tester & Calibration systems suppliers
• Build agreements, contracts, SOWs and POs to support R&D and LCM activities
• Acts as the commercial point of contact for our Testers & Calibration systems business partners
  
  

• Manages the roadmap for all activities required to support company Testing & Calibration needs
• Establish, manage and communicate priorities and status for Calibration team projects to Integra's leadership team and within the organization.
• Engages with internal and external teams to represent T&C in long term planning activities
• Resources management (Manpower, suppliers, Hardware, systems, etc.) to support all R&D and LCM activities
  
  

• Direct management of the Team leader in the department
• Manage the professional development and career progression of engineers and technicians on the team
• Collaboration with all other managers in the Eng. team.
• Represents the Testers & Calibration system department in the Eng. Management
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  
  

• Experience in HW Eng/System Eng/Project management with a good understanding of complicated multidisciplinary systems. Familiarity with several Eng. Fields and disciplines.
• NPI leadership and track record or developing and introducing products to market
• LCM Engineering and track record of sustaining existing products in the market
• At least 3 years of direct management experience of technical professionals
• Experience in a Medical device company or other regulated industry
• Knowledge of GMPs, ISO 13485 Design Control, and manufacturing process qualification requirements for medical devices is strongly preferred
• Several different Eng. or R&D/Operations positions preferred
• Experience in managing relationships with external suppliers and OEMs is required
• Experience in managing subcontractors in the development of hardware and software-based systems
• Strong communication, team building, and cross-functional coordination skills are required
• Ability to travel up to 15% domestic and international is required