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 environmentFunctions as a member of the Global Specialty Brands Leadership TeamPartner 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 design10+ years of functional leadership experience requiredExperience with complex, software-driven, electromechanical medical device productsExceptional Technical Project Management skills with proven track record driving project completion with discipline, exceptional quality, within budget, and on-time resultsExcellent problem-solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issuesEffective 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 acrossAbility 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 marketsDemonstrated excellence in international leadership behaviorKnowledge of regulatory review and response processesProven management and leadership skillsDemonstrated initiative, creativity, strategic capabilities, and strong analytical and financial management skillsAbility to work effectively in a cross-functional, matrix team environmentDemonstrated ability to present data, plans and strategies clearly and accurately to relevant audiences to obtain decisionsStrong understanding of the elements of drug/device development programs

Relationship with Others:

Position reports to the EVP, Quality and Operations.

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