Mallinckrodt Pharmaceuticals
Director, Device Engineering
Mallinckrodt Pharmaceuticals, Madison, Wisconsin, us, 53774
Director, Device Engineering
Job Title:
Director, Device Engineering Requisition:
JR000014638 Location:
Madison, WI Job Description Summary: 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, 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, ensuring compliance with regulatory standards and internal quality systems. Facilitate identification of potential risks in engineering processes and contribute to the development of proactive mitigation strategies. 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. Customer Experience Enhancement: Drive initiatives to improve customer experience and reduce costs, leading and participating in FMEA analyses for device designs. Support complaint management and resolution activities to enhance product quality and customer satisfaction. Program Participation and Development: Participate in programs and projects for product launches and next-generation design initiatives. Oversee and participate in initiatives related to new product development and lifecycle management (LCM). Minimum Requirements: 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+ years experience + Associates). Experience: 15+ years of progressive experience in medical device engineering and product support. 5+ years of functional management experience in a medical device field. 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. Leadership Skills:
Proven capability to lead, mentor, and inspire a multidisciplinary team. Integrity:
Consistent and acts in line with a clear set of values. Strategic Vision:
Ability to articulate a clear vision for engineering excellence. Technical Expertise:
Extensive technical product understanding. Problem Solving:
Excellent problem-solving methodology. Interpersonal Skills:
Effective communication and collaboration skills. Global Collaboration:
Experience working in a global environment is highly desirable. Organizational Relationship: 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. This role serves as the main point of contact for the lifecycle management of released medical devices. Working Conditions:
This position may require occasional travel to global sites, including Dublin, Ireland. Scope of Position:
As the Director, Device Engineering, you will be instrumental in driving engineering excellence and fostering innovation across the organization. #LI-LM1 About Us
Equal Opportunity Employer
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to protected categories. Additional information on Mallinckrodt’s hiring practices may be found by clicking
here .
#J-18808-Ljbffr
Job Title:
Director, Device Engineering Requisition:
JR000014638 Location:
Madison, WI Job Description Summary: 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, 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, ensuring compliance with regulatory standards and internal quality systems. Facilitate identification of potential risks in engineering processes and contribute to the development of proactive mitigation strategies. 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. Customer Experience Enhancement: Drive initiatives to improve customer experience and reduce costs, leading and participating in FMEA analyses for device designs. Support complaint management and resolution activities to enhance product quality and customer satisfaction. Program Participation and Development: Participate in programs and projects for product launches and next-generation design initiatives. Oversee and participate in initiatives related to new product development and lifecycle management (LCM). Minimum Requirements: 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+ years experience + Associates). Experience: 15+ years of progressive experience in medical device engineering and product support. 5+ years of functional management experience in a medical device field. 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. Leadership Skills:
Proven capability to lead, mentor, and inspire a multidisciplinary team. Integrity:
Consistent and acts in line with a clear set of values. Strategic Vision:
Ability to articulate a clear vision for engineering excellence. Technical Expertise:
Extensive technical product understanding. Problem Solving:
Excellent problem-solving methodology. Interpersonal Skills:
Effective communication and collaboration skills. Global Collaboration:
Experience working in a global environment is highly desirable. Organizational Relationship: 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. This role serves as the main point of contact for the lifecycle management of released medical devices. Working Conditions:
This position may require occasional travel to global sites, including Dublin, Ireland. Scope of Position:
As the Director, Device Engineering, you will be instrumental in driving engineering excellence and fostering innovation across the organization. #LI-LM1 About Us
Equal Opportunity Employer
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to protected categories. Additional information on Mallinckrodt’s hiring practices may be found by clicking
here .
#J-18808-Ljbffr