Job Title Senior Director, Global Device Engineering Requisition JR000014646 Senior Director, Global Device Engineering (Open) Location Dublin, IRL Additional Locations Job Description Summary The Senior Director will lead and manage the Global Device Engineering organization for Mallinckrodt. This role has responsibility for establishing the strategy, ensuring appropriate timelines, budgets and other metrics are achieved. The Senior Director will drive existing product support and advanced platform development through interactions with Operations, Quality, Commercial, Clinical & Medical Affairs, R&D Innovation and other key business stakeholders. The Senior Director will provide direct technical and organizational leadership to the device development organization, ensuring a culture of innovation, as well as driving the design for manufacturability and reliability. The Senior Director will partner with Quality and Manufacturing to ensure that processes are in place for all design activities, as well as with Regulatory Affairs to ensure all design activities are sufficient for regulatory agency acceptance. The Senior Director will ensure that all activities comply with the Quality System. Job Description Principal Responsibilities of the role + Direct leadership of engineering department driving a high performing team environment + Functions as a member of the Global Specialty Brands Leadership Team + Partner closely with functional areas such as Quality, Manufacturing and Regulatory to support external audits and certification activities. This includes preparation as well as response to the audit findings. + Drives Quality mindset & behavior related to the role in support of patient need and regulatory compliance. + Create and deploy development strategies while providing tactical leadership for medical device innovation and product support programs. + Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System. + Ensure that program milestones and cost are achieved. + Create and manage design input (user needs) program working collaboratively with Commercial, Medical Affairs, Regulatory, Customer Care and other stakeholders. + Drive a robust CAPA process through the establishment of guidelines, operating principles, procedures and training curriculums. The guidelines should foster a design for six sigma culture, driving design for manufacturing and data driven design for reliability. + Develop and maintain relationships with engineering test labs and appropriate consulting work providers. + Foster innovation culture through the establishment of invention disclosure goals, metrics and IP process. Requirements / Expectations Experience / Skills: + BS degree in a scientific or engineering discipline. Advanced degree required. + 8+ years of complex system design + 10+ years of functional leadership experience required + Experience with complex, software-driven, electromechanical medical device products + Exceptional Technical Project Management skills with proven track record driving project completion with discipline, exceptional quality, within budget, and on-time results + Excellent problem-solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues + Effective at building strong cross functional relationships with the key stakeholders Competencies: + Complex problem solving and decision making based upon the available data. + Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across + Ability to develop relationships and collaborate with external suppliers and Key Opinion Leaders within related industries. + Global medical and/or device and/or regulatory experience in key markets + Demonstrated excellence in international leadership behavior + Knowledge of regulatory review and response processes + Proven management and leadership skills + Demonstrated initiative, creativity, strategic capabilities, and strong analytical and financial management skills + Ability to work effectively in a cross-functional, matrix team environment + Demonstrated ability to present data, plans and strategies clearly and accurately to relevant audiences to obtain decisions + Strong understanding of the elements of drug/device development programs Relationship with Others: Position reports to the EVP, Quality and Operations. #LI-KD1 At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let’s do something dynamic together. Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)