Manager, TruDi(R) Calibration Systems

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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

Life Cycle Management for T&C systems projects

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

T&C Service

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

Project Management for Testers & Calibration systems

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.

Business Partners/Suppliers management

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

Leads the long terms strategy for Testers & Calibration systems

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

Testers & Calibration systems department leadership

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

Qualifications
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