Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Located in the Medtronic office in the Seaport District in Boston, MA as a Senior Human Factors Design Engineer, you will help to execute human factors efforts within the System Architecture Center of Excellence of the Surgical Robotics Organization, working in a fast-paced environment with a team of human factors engineers. This position is on an exciting, challenging, and fast-paced project for a new Surgical Robotics Platform. Your focus will be on evaluating new designs for fit with surgeons’ and OR staff’s expectations and abilities, with a particular eye towards safety and ease of use. Specifically, this position will be responsible for administering usability testing, completion of risk analysis for use-related issues, and other human factors program activities that support documentation for the design history file.

• Lead Human Factors projects supporting business portfolio,
• Moderating usability testing of prototypes with end users and customers,
• Aiding in data collection and root cause analysis during usability testing,
• Usability risk analysis,
• Contribute inputs to design guidance to reduce use risk and improve ease of use,
• OR procedure observation / contextual inquiry,
• Moderate interviews with end users and customers for the purpose of gathering insights,
• Contribute and maintain human factors program documentation as needed for the UE File,
• Participation in planning of human factors program activities,
• Aiding team with preparation of usability-related regulatory documentation for pre-market approval submissions
• Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control enhancements
• Mentorship/coaching role to junior HF staff

Qualifications

Must have: Minimum qualifications:

Bachelor’s degree and 4 years of relevant experience
Nice to have:
As an ideal candidate, you will have any or all of the following experience:
• BS in Human Factors or a closely-related field (such as Biomedical Engineering, Industrial Design) with 4+ years’ experience; MS or higher preferred with 2+ years’ experience (specific experience in medical device development is strongly preferred)
• Experience planning, conducting, and documenting usability testing in a medical device use context; ability to generate design guidance that addresses usability test findings preferred
• Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
• Experience with risk analysis as specifically applied to human factors (e.g., UEA, AFMEA, UFMEA, URA techniques)
• Prior experience managing outside contractors/agencies preferred
• Experience working with complex devices involving both software and hardware preferred
• Capable of working independently and with limited oversight in human factors disciplines
• Excellent analytical, organizational, oral communication, and written communication skills required
• Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask
• Interact and communicate with all levels of employees within the Company, as well as suppliers, customers and peers effectively.
• Comply with policies, procedures, standards and rules of the Company.
• Maintain quality assurance policy consistent with standards.
• Maintain work area in a clean, orderly and safe manner.
• Punctual, regular and consistent attendance.
• Perform all other job-related duties as assigned.
• Must be willing and able to travel ~25% of the time primarily between Boston, MA and North Haven, CT facilities via car or train as well as domestically and internationally at times.
• Must respond to changing requirements and working conditions including changing deadlines and project requirements and strict time constraints.
• Software skills: Microsoft Office (Word, Excel, PowerPoint, Project); experience with qualitative analysis tools a plus.

Responsibilities may include the following and other duties may be assigned.

Applies human centered principles, methodologies, and technologies to the design of human-machine systems and products.
Develops and implements research methodologies and both qualitative and quantitative analysis plans to test and evaluate new concepts and developmental prototypes used in all phases of products development and processes.
Designs and executes tests to simulate product use for the purposes of user need investigation, concept exploration/selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces and overall user experience.
Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans to inform the design direction of new product development.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.