AD, Systems Engineering - Product Development

Position Overview

The Associate Director, Systems Engineering, Product Development is responsible for leading, managing, executing, and completing systems engineering and integration activities associated with the development of new technologies, new products, or improving existing products. This position provides leadership to the team by working to define clear and realistic goals and developing a general management view of projects to enable successful regulatory filings. This position has a clear understanding of all the systems engineering skills and tasks required for successful development program execution for programs which are complex in scope and fall under a rigorous Quality Management System. This position exercises judgment and makes informed decisions using industry best practices and global standards to determine appropriate action or in selecting methods, techniques, and evaluation criteria. This position plays a key leadership role, promoting teamwork in a collaborative environment, to bring new products, product systems, and services to physicians and patients across the cancer continuum.

Essential Duties

include but are not limited to the following:

• Lead systems engineering activities and the development of clear systems engineering standard operating procedures under the Exact Sciences Quality Management system.
• Accountable for developing requirements documentation trees that are leverageable across products and support design changes incorporating hardware, software, and reagents.
• Drive the creation of product requirements that are clear, attainable, and testable.
• Responsible for traceability of design inputs to design outputs, spanning the entire V-model.
• Supports product risk management activities from preliminary hazard analysis (PHA) through failure modes and effects analysis (FMEA) to include documentation of product risk traceability.
• Provide technical leadership; influences decisions affecting project planning and product design.
• Provides oversight and management to a team of systems engineers and systems integration engineers including, but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Collaborate cross-functionally with Business Units, Clinical Affairs, Regulatory Affairs, Quality Control, and other teams to play an integral role in supporting new products and improving processes and procedures that drive quality and productivity.
• Assists in the definition of key development deliverables, milestones, dependencies, risks, and mitigations as part of the Integrated Program Plan.
• Communicate and collaborate closely with functional area leads and Core Team members including business leadership, program management, clinical affairs, quality assurance, regulatory affairs, assay development, software development, and operations to transform strategy into execution.
• Ensure all systems engineering development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
• Fosters the development and strategy of, and drives the activities for, usability and human factors engineering for project core teams including usability risk assessments.
• Develops systems architectures and provides interface control definition amongst system components.
• Ensures robustness of verification and validation activities to support substantiation and compliance for design input requirements.
• Organize, present, and convey clear project summaries, reports, and complex problems and information in written and verbal formats at project meetings, across other functions and to senior management teams.
• Contribute in-depth, technical knowledge to improve staff capabilities.
• Participate in technical decisions, identify problems, perform root cause analysis, investigate alternatives, and recommend possible courses of action.
• Communicate goals clearly to employees to ensure understanding and success in achieving them.
• Motivate and inspire employees to do their best work through coaching while maintaining morale and supporting employee engagement initiatives.
• Utilize excellent verbal and written communication skills to convey important messages and drive focus through a variety of communication methods.
• Adaptable, open to change, and able to work in ambiguous situations and respond to new information, unexpected circumstances and changing priorities.
• Excellent analytical, problem solving, and decision-making skills.
• 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.
• Regular and reliable attendance.
• Ability to work nights and/or weekends.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• PhD in Engineering, Life Sciences, Mathematics, Physics, or related field; or Master's degree and 4 years of experience in lieu of PhD; or Bachelor's degree and 6 years of experience in lieu of PhD.
• 8+ years of industry or academia experience.
• 6+ years of experience in medical device/IVD, biotech, life science, or pharmaceutical industry.
• Demonstrated understanding of ISO 13485 standard and Code of Federal Regulations (CFR) 21§ 820.30 Design Controls and previous experience developing products under design control as well as risk management standards (e.g., ISO 14971).
• Demonstrated experience in complying with IVDD (98/79/EC) and IVDR.
• Demonstrated knowledge and experience with industry best practices in requirement management.
• Demonstrated understanding and experience in applying international standards for usability and human factors engineering.
• Proficient in Microsoft Office to including Excel, Word, and Power Point.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• 8+ years as a leader developing in-vitro diagnostic tests, reagent kits or diagnostic systems.
• Experience in a pharmaceutical or biotech manufacturing environment, preferably in a GMP and/or ISO environment.
• Previous experience working in a molecular diagnostics/clinical laboratory setting.

If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email [email protected].

We are 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 are available to any applicant or employee for inspection upon request.