Director, Device Engineering

Job Title

Director, Device Engineering

Requisition

JR000014638 Director, Device Engineering (Open)

Location

Madison, WI

Additional Locations

Job Description Summary

Job Description

We are looking for an experienced Director of Device Engineering to join our senior leadership team at our Madison, WI medical device manufacturing site. This key role is central to driving engineering innovation, optimizing product performance, and maintaining a strong focus on patient safety. Leading a multidisciplinary engineering team, you will offer strategic and technical leadership, aligning engineering initiatives with business objectives to achieve excellence and efficiency. You will play a crucial part in shaping the future of medical device engineering, ensuring regulatory compliance, and fostering a culture of innovation and collaboration across teams.

As part of the Site Leadership Team (SLT), you will collaborate with the Global Device Engineering (GDE) organization based in Dublin, Ireland, to implement industry-leading practices and propel initiatives in new product development and Life Cycle Management (LCM). Acting as the Madison Global Device Representative, you’ll work closely with key stakeholders across Commercial, Regulatory, Customer Care, and Operations to support product performance, lead platform development, and champion design for manufacturability and reliability.

Essential Functions

Leadership and Strategy:

• Provide leadership and clear direction to the engineering team, setting goals and objectives that align with business priorities.

• Develop and implement engineering strategies to enhance product performance, safety, reliability, and regulatory compliance.

• Act as a key member of the site leadership team, contributing to overall site strategy and operations.

Team Management:

• Lead, mentor, and develop a high-performing engineering team, fostering a culture of collaboration, accountability, and professional growth.

• Oversee the Sustaining Engineering, and Manufacturing Engineering functions to ensure alignment with project goals and business objectives.

Cross-Functional Collaboration:

• Collaborate closely with the Global Device Engineering team and other functional areas, such as Quality, Regulatory, and Manufacturing, to drive innovation, ensure consistency in engineering processes, priorities and support successful product launches.

• Facilitate cross-functional reviews to support regulatory submissions and ensure compliance.

Product Performance and Reliability:

• Oversee product performance optimization through cross functional collaboration, post-market surveillance, and obsolescence management.

• Direct ongoing evaluations and testing to ensure component reliability and continuous improvement, establishing and overseeing test methods for device and component reliability.

Risk Management and Compliance:

• Support QA in Leading Risk Management Activities: Collaborate with the QA team to ensure that all hazard and risk mitigation initiatives for system and device development are effectively executed, ensuring compliance with regulatory standards and internal quality systems.

• Facilitate Identification of Potential Risks: Work alongside QA to identify potential risks in engineering processes and contribute to the development of proactive mitigation strategies that align with overall project goals.

Continuous Improvement and Problem Solving:

• Champion continuous improvement initiatives within the engineering function, leveraging data and metrics to drive decision-making and enhance product quality.

• Lead multi-disciplinary teams in effective problem-solving initiatives to address product performance and quality issues, ensuring timely resolution and customer satisfaction.

Customer Experience Enhancement:

• Drive initiatives to improve customer experience and reduce costs, leading and participating in FMEA analyses for device designs and collaborating with Quality Engineering for statistical modeling.

• Support complaint management and resolution activities to enhance product quality and customer satisfaction, implementing corrective actions as needed.

Program Participation and Development:

• Participate in programs and projects for product launches and next-generation des