Senior Director, Systems Development
Summary of Major Responsibilities
The Senior Director, Systems Development leads the development of instruments, software, and equipment used in clinical laboratories to perform diagnostic tests. The Senior Director works with cross functional teams to ensure that user, customer, and business needs are correctly captured and translated into design specifications, implemented, and verified and validated under quality system design control. This role applies strong technical, project and personnel management skills to ensure project success and develop engineers to assume roles with increasing responsibility. This position reports to the VP Systems Development.
Essential Duties and Responsibilities
- Lead a team of staff responsible for development of software and automated equipment with processes used to test patient samples in a clinical laboratory. Provides leadership which includes technical guidance, interviewing, hiring, training, providing leadership, goal setting, including performance evaluation, prioritization of work and compliance with personnel and safety policies.
- Provides leadership and management of the execution of key projects, applying detailed knowledge of scientific competencies to develop company products within the defined product area, and to recommend product enhancements.
- Actively engage with key stakeholders to comprehend the spectrum of available technology options and collaborate on their integration and application to products.
- Serve as the technical lead on preparing reports and analysis and interpretation of data and results as related to system/software/hardware development and improvement. Actively participates with research and technology efforts to ensure alignment with strategic priorities.
- Collaborate 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.
- Partner with cross functional leads in Marketing, Clinical and Regulatory Affairs, among others, to ensure appropriate understanding and documentation of product requirements and timely delivery of products.
- Prepare reports and analysis of results related to product/process development and improvement. Report status of assigned projects through the preparation of detailed reports and documentation that summarize experiment results. Interprets results of experiments and recommends alternative approaches.
- Lead system development decisions affecting product development issues. Leads the process to identify problems, investigate alternatives and collaborate on the development of potential solutions.
- Knowledgeable of industry developments that may complement current activity to meet business objectives.
- Effectively utilizes and applies advanced methods or technologies. Contributes ideas for new product development within or beyond existing markets.
- Conduct creative analyses and high-level decision-making.
- Manage development and integration of instruments, software, and automated equipment with processes used to test patient samples in a clinical laboratory.
- Determine system design architectures, workflows and specifications.
- Guide creation and evaluation of design concepts and encourage staff to find robust solutions.
- Manage external vendors to meet part/assembly design specifications.
Occasional Duties and Responsibilities
- Occasional travel may be required.
- Demonstrated experience in a senior role with a well-established IVD or medical device company.
- Demonstrated experience in developing and managing the development of an integrated assay reagent/instrument product.
- Demonstrated experience and knowledge of fluid handling, robotics, software and chemistry for quantitative measurement.
- Demonstrated experience with CFR 21 part 820 and ISO 13485 compliance for software and instrumentation development.
- Demonstrated ability to develop and maintain effective relationships across the organization to ensure contribution and strategy “buy in” on strategic initiatives relating to instrumentation plan implementation.
- Strong teaching/training skills.
- Exceptional presentation skills.
- Ability to interface and collaborate effectively within team and department, as well as all levels of the organization, vendors, customers, etc..
- Proven ability to lead effective teams while maintaining a positive, energetic and collaborative culture.
- Excellent attention to detail and meticulous record keeping.
- Excellent analytical, problem solving, organizational, and decision-making skills.
- Proven ability to work collaboratively with scientists, engineers and software programmers.
- Energetic, resourceful and hands-on individual with a strong service orientation and bias for action; understands impact of decisions or strategies.
- Demonstrated ability in effectively articulating short-term plans with long-term vision and communicating it in a compelling and actionable manner throughout the organization.
- Team-centric with the ability to forge and engage strong diverse teams and engaging them through their excitement and passion for accomplishing their goals and the goals of the organization.
- Proficient in C, C++, C#, STL, or SQL.
Education and Experience
- Bachelor's of Science in engineering, physical science or related field of study plus a minimum of 15 years’ experience, or Master’s degree in in engineering, physical science or related field plus a minimum of 10 years’ experience, or Ph.D. in in engineering, physical science or related field plus minimum of 5 years’ experience, or equivalent combination of education and experience.
- Advanced degrees strongly preferred.
- Minimum of 10 years’ of supervisory experience with direct responsibility for performance management, development, coaching, hiring and training direct reports.
- Demonstrated career of outstanding accomplishment and contribution. Including 12-15 years of progressive Diagnostics industry experience.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit for extended periods of time.
- Ability to stand for extended periods of time and up to 6 hours at a time.
- Ability to travel (by land and air), both domestically and internationally, on occasion.
- Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
- Constant walking or motion to coordinate work and interact with co-workers.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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