Director, Human Factors Engineering

Thornton Tomasetti; Milpitas (CA); On-site; USD 172,000 - 344,000; Full time

Job summary

Abbott is seeking a senior leader in Human Factors Engineering to drive usability across the product lifecycle in Milpitas, CA. You will guide strategy, method development and cross-functional collaboration with R&D, UX, and market research to de-risk development plans.

The role requires a track record of leading high-performance teams in regulated settings, strong communication, and global stakeholder engagement, including travel.

Qualifications

• Experience leading Human Factors across the product lifecycle.
• Shipped multiple medical devices with regulatory approvals.
• Experience with ethnographic research and user needs identification.
• Ability to travel internationally.

Responsibilities

• Directs activities to ensure new product development within scope, timeline and budget.
• Leads recruitment and development of organizational talent.
• Fosters a diverse workplace and entrepreneurial environment.
• Provides strategic direction to managers and staff.
• Coordinates across functions to reach division goals.
• Mentors staff on usability theory and technology.
• Ensures compliance with FDA regulations and company policies.

Skills

Human Factors

Leadership

Program management

Cross-functional collaboration

Regulatory knowledge

Communication

Education

Bachelor's or MS in HF Eng / Biomedical Eng / Electrical Eng / CS / ME

PhD in related field

Tools

Regulatory standards knowledge

Ethnographic research methods

Job description

JOB DESCRIPTION

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

WHAT YOU’LL WORK ON:

Provides leadership, vision and direction of the ADC Human Factors Engineering and Usability Function. Responsible for developing and leveraging product development, data interpretation and establishing external relationships to drive human factors and usability work. Collaborates across R&D and the division to develop tools to optimize products and development programs strategy and budgets. Develops processes, tools, and methods that advance evaluation of product designs and concepts at all phases of design. Collaborates with upstream partners (product managers, market research, UX designers, etc.) to streamline development and de-risks development efforts. Responsible for effective people leadership, up to Sr. Manager level staff. Conduct high level program management coordination and strategic division ownership for a wide range of analytical methodologies, approaches and techniques for product characterization. Manage direct reports at manager, and administrative levels. Provide management guidance for their organizations to ensure market leading use of technology and product development.

MAIN RESPONSIBILITIES

• Directs activities to ensure new product development activities are achieved within agreed upon scope, timeline, and budget


• Recruits, coaches and develops organizational talent


• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives


• Creates an entrepreneurial environment


• Provides general direction to managers, exempt specialist and non-exempt support in various areas, groups and/or operations


• Keeps the organization’s vision and values at the forefront of decision making and action


• Plans and conducts worldwide customer, competitive, and software industry research to identify and prioritize usability improvement possibilities and solutions


• Builds strategic partnerships to further departmental and organizational objectives


• Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers


• Coordinates across functional areas, business units, and/or geographies in order to achieve Division goals


• Provides global strategic marketing, engineering management, and staff with training and mentoring on usability theory, resources, and technology


• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA regulations, etc.)


• Makes and executes operational decisions with a strategic perspective


• Directs and controls the activities and budget of one or more functional areas, product groups and/or third party vendors

QUALIFICATIONS

• Bachelor’s or M.S. degree in Human Factors Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, Mechanical Engineering or other scientific or engineering field


• 10-15 years of management and technical management experience in the medical device industry with minimum 5 years at a senior management role


• Demonstrated track record of building and driving high performance teams in a highly regulated environment – you have shipped multiple products


• Experience leading Human Factors activities across the product lifecycle, including ethnographic research, user needs identification, workflow and task analysis, requirements development, user interface design, user error analysis, usability and validation testing


• Extensive knowledge of entire medical device development process from needs definition through regulatory approvals, production, launch, and product life cycle maintenance


• Proven ability to work with cross-functional teams and provide technical leadership


• Proven ability to interface with customers in a highly professional manner
  
• Ability to quickly assimilate advanced domain knowledge


• Self-motivated problem solver who finds pragmatic solutions to highly technical challenges


• Excellent verbal and written communication and presentation skills


• Ability and desire to travel, including internationally

PREFERRED QUALIFICATIONS AND EDUCATION

• Ph.D. degree in one of the above disciplines


• Experience in medical device development especially in system engineering and/or risk management


• Working knowledge of cardiac electrophysiology


• Working knowledge of Human Factors/Usability Engineering regulatory standards

BASE PAY

The base pay for this position is $172,000.00 – $344,000.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Product Development

DIVISION

ADC Diabetes Care

LOCATION

United States > Milpitas: 1820 McCarthy Blvd

WORK SHIFT

Standard

TRAVEL

Yes, 10 % of the Time

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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