Director of R&D - Electrophysiology

Heraeus Group•Fridley, MN

8d•Hybrid

About The Position

Within a start-up environment, the Director of R&D – Electrophysiology provides functional leadership to core teams of project management, process development engineers, manufacturing engineers, automation engineers, and technicians responsible for the successful execution of global new product and process development initiatives within the electrophysiology product space. The Director of R&D - Electrophysiology must possess the ability to define functional objectives supportive of overall strategic goals, drive effective execution across a diverse portfolio of projects and develop people. These teams may exist across multiple sites and work across multiple product areas with a focus on electrophysiology catheter development for our medical device OEM customers. This position is based out of our Fridley, MN location with travel up to 50% to our Costa Rica site.

Requirements

Bachelor degree in Mechanical Engineering or a related technical field required
Minimum 10 years of relevant experience in technical/medical device development and/or manufacturing experience.
Minimum of 5 years of previous management and leadership experience required.
Experience in the field of electrophysiology catheters required.
Demonstrates strong leadership, communication and managerial skills
Must be willing and able to travel up to 50%, mainly between Minnesota and Costa Rica.

Nice To Haves

Master’s degree preferred.
Six sigma background or lean manufacturing experience preferred
Experience in various medical device areas such as neuromodulation and interventional a plus

Responsibilities

Lead teams responsible for owning process development from concept through transfer including process capability, process quality deliverables, process cost, and technology improvements.
Provide direction to technical resources at both the manager and individual contributor levels while identifying and supporting the developmental needs across the team.
Provide technical and direction for process characterization skills and tools such as Design of Experiments (DOE), pFMEA, mitigation to foreseen risks, and capability analysis.
Accurately and effectively report and communicate progress and issues to leadership in order to support project objectives.
Partner effectively and proactively with other functional leaders and teams including Project Management, Product Engineering, Operations, Quality, Commercial, Regulatory, Portfolio Management, and others as applicable.
Support Project Management in the execution of a project portfolio by understanding and setting priorities, managing resources and mitigating risks in order to achieve milestones.
Support Project Management with accurate assessments of functional capabilities execution status.
Ensure that proper technology processes are developed, implemented, maintained, and documented to successfully introduce new products into manufacturing.
Involved in prototyping, process development, process characterization, and validation (OQ/PQ support at transfer site).
Assume responsibility for completeness and accuracy of developed processes (i.e., lead, manage, communicate, complete documentation, train) including ownership of process capability, process quality, and process costs.
Align and optimize team performance across sites and project teams to make best use of available skills and resources.
Coordinate new equipment identification, procurement, installation qualification (IQ), document creation, and training.
Identify new technologies in accordance with site and customer priorities to improve efficiency, quality, reduce costs, and meet market technology needs.
Responsible for the costing of projects and support of costing for high volume pricing.
Lead and develop a team of individual contributors and managers by recruiting, assigning work, setting clear and achievable goals, providing ongoing coaching and feedback, and managing performance and career development in alignment with company policies and applicable laws.
Other duties may be assigned as required.