Director R&D, Software Engineering and Digital Health Solutions
Job Description Summary
SUMMARY JOB DESCRIPTION:
Director Software Engineering and Digital Health Solutions R&D - Diabetes Care, is expected to lead a team of software engineers, data scientists and application development engineers focused on product development of complex new-to-world medical device solutions and digital health platforms that help people with diabetes live healthier lives. Scope includes development of interconnected diabetes management solutions – consisting of a combination of connected drug delivery and data science (applications and algorithms) components – that improve clinical and economic outcomes (by lowering the functional and emotional burden of effective self-care). In this role, the ideal candidate will drive functional excellence in identifying, breaking down and solving deep technical problems associated with design and development of embedded systems, analytics platforms and application software, needed behavioral design and personalized decision support frameworks (that drive patient engagement). S/he will expand the capabilities of the organization through a combination of development of internal capabilities and formation of external partnerships, and drive productivity in product development. S/he will collaborate closely with the injection, infusion and digital health platform leaders in identifying regional and global unmet needs, developing new concepts, transferring new innovations into product development, and ultimately delivering the product portfolio vital to growth of the business. S/he will have a proven track record of leadership in innovation, technology and product development including predictable execution, accountability, customer focus, and talent development. S/he will participate with other members of the Diabetes Care, Leadership Team to establish strategic plans and objectives. Business acumen is required to align actions to strategic business objectives. This person must ensure compliance with BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
The Director will demonstrate a strong background of leadership that:
- Ensures excellent planning and effective use of resources that will achieve organizational goals.
- Is proactive, able to deliver and execute.
- Can regularly and effectively interact with other senior leaders for briefings and technical meetings.
- Uses independent judgment to develop strategies and implement operational policies and directives.
- Effectively communicate progress toward project/program goals.
- Has developed leaders and direct reports for current and future needs and will positively align talent decisions to strategic plans.
- Has strong business acumen and customer centricity, is proactive and able to deliver and execute to business milestones.
- Shows leadership agility, cross functional influence, and excellent communication
- Drives and leads problem resolution at an accelerated pace using new approaches and methodologies.
- Demonstrates project management skills utilizing Agile/Scrum software development practices; effective work collaboration with Product Owners and Scrum Masters.
Functional Management Responsibilities:
- Interact routinely with R&D Leadership on matters concerning software engineering technologies, development projects, and business milestones.
- Influence R&D Software functional strategy on matters including core capabilities, software quality, software processes, resource development and utilization, and technology roadmaps.
- Work closely with other R&D Software Leaders to establish and align Software department level plans and objectives with business and R&D strategic plans and objectives
- Identify talent and hire associates with the capabilities needed to meet the department objectives
- Assess and manage performance and development of associates within the group on an ongoing basis
- Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship
- Provides input into yearly budget planning and ongoing resource planning
- Define the engineering capabilities required to meet new product development and sustaining objectives
- Influence the continuous improvement of the software development process to ensure high quality, robust software development work products via metrics and software processes.
- Ensure the application of best practice software engineering methods to produce robust software designs
- Drive cross project standardization and maximize software component reuse
- Influence the selection of appropriate technology, technology partners and development partners to ensure project success
- Ensures compliance to BD quality standards and conveys an expectation of high software quality
Apply Software Engineering expertise in a leadership role
- Lead or participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements.
- Plan and lead technical development activities of complex instrumentation systems and software from concept through successful commercialization, within established schedules, budgets, and product cost targets
- Drive tactical and strategic planning for system/software architecture across the BDDS product line
- Provide technology assessment of competitive systems
- Provide a technical interface to key opinion leaders and major customer
EXPERIENCE & EDUCATION:
- MS degree in Computer Science Computer Engineering, Mathematics, Physics or a related Engineering discipline; MS in a related discipline preferred; MBA and/or a PhD would be a plus.
- 12+ years of experience in software development, instrumented systems and architecture concepts and designs.
- Experience with digital health and embedded software solutions for Diabetes products highly preferred
- Ten years leading engineering product development teams and/or functional management oversight for SW development.
- Subject matter expertise in embedded systems engineering with working knowledge of complex algorithm and application development for devices and digital health applications; 10+ years demonstrated experience in leading global software engineering teams towards development and commercialization of novel products, preferably in the health care space.
- 5+ years demonstrated experience in leading product development teams with oversight of a combination of hardware, software, and analytics/data science functions, preferably focused on development and delivery to market of novel medical devices (FDA Class 2 minimum).
- Demonstrated experience leading software teams that connect novel medical devices to cloud architectures that enable complex product and business ecosystems.
- Demonstrated ability to adapt Agile Software development and Lean Product Management practices to regulated medical product market spaces.
- Demonstrated track record of at least 8 years attracting and managing diverse technical talent.
KNOWLEDGE, SKILLS AND ABILITIES:
- Demonstrated ability to inspire and develop a high performing diverse team across sites.
- Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements including design control. This includes understanding of phase gate process.
- Demonstrated deep understanding of establishing project and product requirements.
- Successful track record of developing multiple commercially viable complex medical device products and delivering to market.
- Regulatory standards (ISO14971, ISO 13485), and system level V&V planning and execution.
- Knowledge of Design for Six Sigma (DFSS) methodology.
- Successful experience working with outside contract development groups and the ultimate transfer to internal resources for a successful product launch.
- Business acumen to align actions with business objectives, knowledge of business context and goals, finance & marketing knowledge, knowledge of legal agreements and IP processes.
- Excellent verbal and writing skills as well as presentation expertise to senior level leadership.
- Organizational awareness and ability to garner support at all levels for a course of action.
- Highly collaborative both within the function and with other functions
- Advanced leadership, interpersonal and influencing skills.
- Advanced technical and managerial judgment; advanced problem-solving skills.
- Self-initiator, results driven and action & detail oriented.
- Disciplined and well organized.
- Demonstrated learning agility of new subject matter.
- Understanding and use of an innovation process utilizing elements of search, synthesis, and select.
- Strong passion for the diabetes epidemic and motivation to simplify the management of diabetes
- Ability to travel approximately 25% of the time, and international travel will be required.
Primary Work LocationUSA MA - Andover
Additional LocationsUSA NC - Research Triangle Park
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ