Sr Director, Systems Development/Automation Engineering

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Position Overview

The Senior Director, Systems Development serves as a thought leader and subject matter expert, and collaborates with cross-functional leaders and stakeholders to define, invent, design, and develop custom automation that supports improved performance and throughput of complex in vitro diagnostic tests. The Sr. Director leads the creation of the system architecture that defines the breakdown of the automation needs into designs of sub-systems, modules, components, and interfaces needed to automate the diagnostic test processes. Managing and coordinating teams of engineers, the Sr. Director ensures that that user, customer, and business stakeholder needs are correctly captured and translated into design specifications, implemented, and verified and validated under quality system design control. This role applies expert technical, project and personnel management skills to ensure project success and to develop engineering staff to assume roles with increasing responsibility. This position reports to the R&D Systems Development function.

Essential Duties

Include, but are not limited to, the following:

• Work on significant and unique issues where analysis, situations, or data requires an evaluation of intangible variables and may impact future concepts, products, or technologies.
• Work on multiple projects that are extremely complex in scope, often across multiple groups and sites.
• Guide creation and evaluation of highly complex medical device automation design concepts while encouraging staff to invent robust solutions.
• Lead design of highly complex system architectures that incorporate control systems, hardware, and software to automate medical devices.
• Guide engineers in decomposition of system architectures into successive layers of items/modules with interactions between modules and layers defined by concise interfaces.
• Lead engineers in implementation of items/modules by engineering disciplines including automation, controls, electrical, mechanical, and software.
• Select common core technologies to support development across different automation programs.
• Lead work on multiple projects that are extremely complex in scope, often across multiple groups and sites.
• Determine the scope, technical difficulty, plans, time, resources, and risks associated with new automation programs.
• Determine and implement best practices for invention and development of new automation solutions.
• Determine standards and best practices for documentation of complex automation projects.
• Interpret results of tests and experiments, conduct creative analyses, recommend alternative approaches to product/process development and improvement, and execute high-level decision-making.
• Create and manage high-level schedules and resource plans for automation projects and programs.
• Deliver effective written and oral presentations of designs, analyses, findings, and recommendations to project teams, senior management, and leadership teams.
• Provide deep technical expertise on design control process and documentation and create structure for highly complex automation projects.
• Lead identification of areas for process and product improvements.
• Lead teams in creation of unit, module and system design specifications from stakeholder needs.
• Troubleshoot multi-disciplinary system issues and failures, determine root cause of failures, and recommend corrective actions.
• Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining solutions.
• Communicate and record issues, defects, bugs and contribute to their resolution.
• Contribute ideas for new products and product improvements.
• Create new unit, module and system level design control documentation as required.
• Design templates and set examples and best practices for design documentation.
• Influence company policies for design documentation to least burdensome principles.
• Report status of assigned projects and tasks for self and teams.
• Lead and guide risk and failure mode and effect assessments of complex, multi-component systems, from unit to module through system level.
• Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicategoals clearly to employees to ensure understanding and success in achieving them.
• Motivateandinspireemployees to do their best work through coaching.
• Maintainmorale and support employee engagement initiatives.
• Develops and maintains effective relationships across, up and down the organization to ensure contribution and buy-in on strategic initiatives relating to Systems Development contributions to projects and products.
• Collaborates with Product Development and integration teams responsible for the design and development of clinical diagnostic products to meet product design goals while maintaining compliance with the Quality System Requirements.
• Actively engages with key stakeholders to comprehend the spectrum of available technology options and collaborate on their integration and application to products.
• Applies expert written and oral and written communication skills to inform and influence stakeholders, resolve conflicts, build consensus, and drive focus.
• Accepts extreme ambiguity and works to find appropriate compromises and resolution.
• Works on a several complex and varied projects at one time, while navigating and adapting to ambiguous and changing plans and circumstances.
• Ability to communicate clearly and frequently with all levels of the organization, to include team members, core and extended project team members, functional managers, clinical lab, and other stakeholders.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends as needed.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• May be required to work, with provided training and protective equipment, in presence of chemical, biological, electrical, temperature, and energy hazards.
• Ability and means to travel 80% of annual working time between base city locations.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• PhD in engineering or physical science or field as outlined in the essential duties; Master's degree in engineering or physical science or field as outlined in the essential duties plus 2 years of relevant experience in lieu of a PhD; or Bachelor's Degree in engineering or physical science or field as outlined in the essential duties plus 4 years of relevant experience in lieu of a PhD.
• 16+ years of experience related to development of automation.
• 11+ years of experience in medical device/IVD, biotech, life science or clinical automation industry.
• 12+ years of supervisory experience with demonstrated ability to hire, lead, develop and train direct reports effectively.
• Expert computer skills to include internet navigation and email usage.
• Expert in Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, OneNote, Teams, and Visio.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Advanced degree in engineering, physical science or related field.
• 18+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
• Knowledge of clinical laboratory instrumentation and procedures.
• 16+ years previous experience in research and development managing a team of engineers.
• Previous success in bringing diagnostic products to market under an IVDR or FDA-regulated environment.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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