Scientists and Engineers create our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.
The Principal Human Factors Engineer/Scientist demonstrates quality in all actions; Responsible for the development, execution and maintenance of usability studies related labeling content. The Principal Human Factors Engineer will organize and manage all activities related to the validation of the Instructions for Use and Patient Manuals content. The Principal Human Factors Engineer will work with external suppliers and internal stakeholders to ensure that product samples and labeling materials needed to support labeling validation studies are available. The incumbent will make recommendations on when/how validation efforts may be combined to gain efficiencies. Works on complex issues where analysis of situations of data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
Essential duties and responsibilities
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Perform human factors/usability engineering, verification and validation (V&V) tasks in support of changes to labeling.
• Draft verification and validation plans, protocols, prepare test cases, perform dry runs of the protocols, validate test set-ups, and generate verification/validation reports.
• Assist in coordinating testing with outside firms and/or internal personnel.
• Participate in the planning and coordination of user meetings in support of labeling validation activities.
• Capture discrepancies during/after testing, and assist in driving them to resolution.
• Participate in technical reviews and cross-functional documentation reviews related to labeling.
• Participate in technical evaluation of new products for usability as it relates to labeling.
• Participate as a member of cross-functional product development teams.
• Assist in the development of procedures related to labeling validation.
• Maintains close contact with appropriate functional groups to assure effective communication in regards to the needs and status of assigned study execution activities.
• Responsible for creating and communicating timeline of activities related to labeling validation to internal stakeholders.
• Responsible for generating change orders and ensure the timely approval of labeling validation protocol and report in the Company’s electronic approval system.
• Procure materials needed to support labeling validation.
• Provides recommendations on changes to labeling content as a result of labeling validation findings.
• Travel to support labeling validation activities may be required.
• Responsible for regulatory submissions related to labeling (Instructions for Use, Patient Manual, etc.)
• Represent Regulatory Labeling in core team meetings.
• May provide support to regulatory submissions as needed
Determines methods and procedures on new assignments and may coordinate activities of other personnel.
Required Knowledge, Skills, Abilities
• Excellent written and verbal communication skills.
• Ability to handle multiple priorities successfully.
• PC application skills: MS Project, Excel, Word
Required Education/ Experience
• BA / BS degree in Engineering or Life Sciences
• 7-10 years of overall Industry experience
• Minimum of 3 to 5 years of relevant experience working in a medical device or pharmaceutical environment.
• Understanding of human factors usability engineering is required.
Nice to Have:
• Project management or project coordinator experience
• Experience in product development
• Usability studies experience
• Human Machine Interface expert
ADDITIONAL PHYSICAL JOB REQUIRMENTS:
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.
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.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.