Director, Device Engineering

Job Title

Requisition

Location

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.

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 design initiatives, ensuring engineering standards align with customer needs and market demands.

• Oversee and participate in initiatives related to new product development and lifecycle management (LCM), developing appropriate metrics for tracking and supporting continuous improvement efforts, ensuring that engineering activities prioritize product performance, patient safety, design for manufacturability and quality.

Education:

• Bachelor's degree in an engineering discipline (Mechanical, Biomedical, Electrical Engineering, or a related field)

• Master's degree/MBA or equivalent advanced degree desired.

• Significant work experience in medical devices may be substituted for the degree. (20+yrs experience + Associates)

Experience:

• 15+ years of progressive experience in medical device engineering and product support, with a proven track record in leadership roles.

• 5+ years of functional management experience in a medical device field, with a strong background in product development, sustaining engineering, and manufacturing processes.

• Experience with complex, software-driven, electromechanical medical device products is preferred.

• Familiarity with regulatory audit preparation and participation.

Skills/Competencies:

• Program & Project Management: Exceptional technical program management skills with a strong track record of driving project completion with discipline, quality, within budget, and on-time results.

• Leadership Skills: Proven capability to lead, mentor, and inspire a multidisciplinary team, fostering a culture of collaboration, innovation, and accountability.

• Integrity: Is a person of high character; is consistent and acts in line with a clear and visible set of values and beliefs; deals and talks straight; walks his/her talk; is direct and truthful but at the same time can keep confidences

• Strategic Vision: Ability to articulate a clear vision for engineering excellence and drive strategic initiatives, across functions, that align with organizational goals.

• Technical Expertise: Extensive technical product understanding, with experience in best-in-class product development and complex problem-solving skills. In-depth knowledge of cGMP requirements, ISO 13485, ISO 14971, and other relevant regulatory standards.

• Problem Solving: Excellent problem-solving methodology, utilizing industry-accepted concepts and tools to address complex issues effectively. Independently identifies potential issues impacting deliverables and analyzes interdisciplinary problems to find solutions.

• Interpersonal Skills: Effective communication and collaboration skills, with the ability to influence stakeholders at all levels. Proven ability to build strong cross-functional relationships and collaboration with external stakeholders.

• Global Collaboration: Experience working in a global environment and liaising with international teams is highly desirable.

The Director, Device Engineering is a key member of the Madison Senior Leadership Team (SLT) and is responsible for leading a diverse group of direct reports, including both full-time staff and contractors. This role serves as the main point of contact for the lifecycle management of released medical devices, regularly collaborating with key stakeholders across various functions such as Quality, Operations, Commercial, Regulatory, Clinical, and Customer Care, among others. To effectively drive strategic alignment, the Director must have a solid understanding of the organization's products and platforms.

This position may require occasional travel to global sites, including Dublin, Ireland.

Scope of Position

As the Director, Device Engineering at the Madison medical device manufacturing site, you will be instrumental in driving engineering excellence and fostering innovation across the organization. You will lead a multidisciplinary team, setting clear goals and establishing strategies that align with business objectives and regulatory requirements. Your role will encompass overseeing initiatives related to new product development and lifecycle management (LCM), ensuring that engineering activities prioritize product performance and patient safety. By collaborating closely with the Global Device Engineering organization in Dublin, you will share best practices and promote cross-functional teamwork, engaging with stakeholders from Commercial, Regulatory, Customer Care, and Operations. This position emphasizes compliance, operational efficiency, and a culture of continuous improvement, while driving initiatives to enhance customer experience and reduce servicing costs. You will utilize data-driven decision-making, manage risk effectively, and actively contribute to product launches and next-generation design initiatives, ensuring that engineering efforts align with market demands.