Human Factor
Human Factor
Posted on :
29-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
29-05-2025
Job Description
Job Description:
Reporting to the Medical affairs (MA) this role defines work roles and oversees human factors user experience and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following the clients procedures. The Senior Manager will lead a Human Factor review and all related activity including management schedule and verifications. In this key strategic and technical leadership role additional responsibilities will be to ensure collaboration with peer leaders across R&D Quality Marketing Clinical and Scientific Affairs Operations R&D and Regulatory functions as well as any other key stakeholders including those external to the clients.
This person must ensure compliance with the clients ethics quality policies procedures and practices through appropriate communication training and education of sound quality assurance principles. They must also ensure compliance with all local state federal and the clients safety regulations policies and procedures.
Responsibilities:
Reporting to the Medical affairs (MA) this role defines work roles and oversees human factors user experience and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following the clients procedures. The Senior Manager will lead a Human Factor review and all related activity including management schedule and verifications. In this key strategic and technical leadership role additional responsibilities will be to ensure collaboration with peer leaders across R&D Quality Marketing Clinical and Scientific Affairs Operations R&D and Regulatory functions as well as any other key stakeholders including those external to the clients.
This person must ensure compliance with the clients ethics quality policies procedures and practices through appropriate communication training and education of sound quality assurance principles. They must also ensure compliance with all local state federal and the clients safety regulations policies and procedures.
Responsibilities:
- Guide completion of major programs including Human Factors Validation in support of new product development and sustaining engineering.
- Collaborate with peer leaders in product development as well as technology development efforts.
- Partner internally and externally to implement best practices regulatory standards and guidelines to generate high quality information to ensure innovative device design to meet unmet medical needs in alignment with the the clients mission.
- Manage the human factors activities defined in program goals such as: user interface user experience Instructions for Use (IFU) formative studies and summative studies. Help shape the overall vision and strategy for human factors engineering within the clients and support preclinical clinical tests.
- Advise and inform the leadership staff to develop strategy tactics and execution of development plans. Provide expert guidance technical & process insight for core teams to overcome challenges and meet business expectations for product development.
- Create a team culture that supports open communication collaboration across teams and empowerment to employees.
- Minimum of a bachelors degree in human Factors/Ergonomics Engineering Applied Science in Industrial Engineering Industrial and Systems Engineering Engineering Psychology Bioengineering Biomedical Engineering or a closely related technical or scientific degree is required.
- 8 years demonstrated experience (based on own subject matter expertise) in human factors engineering or equivalent user-based test experience.
- Established expertise in areas including risk management user needs research such as translating HFUXD findings into user-needs/requirements user risk and/or design solutions related to the user interfaces management of human factors and usability engineering file.
- Strong experience with relevant medical device standards including IEC 62366-1 ISO 13485 ISO 14971 FDA Guidance for Design Controls.
- 8 years of experience in product development; Medical Device experience highly desired.
- Masters degree in human Factors/Ergonomics Engineering Applied Science in Industrial Engineering Industrial and Systems Engineering Engineering Psychology Bioengineering Biomedical Engineering or a closely related technical or scientific degrees are preferred.
- Excellent verbal and writing skills as well as presentation expertise to senior level leadership.
- Advanced leadership interpersonal and influencing skills.
- Organizational awareness and ability to garner support at all levels for a course of action.
- Strong experience with relevant medical device standards including IEC 62366-1 ISO 13485 ISO 14971 FDA Guidance for Design Controls. Demonstrated breadth and depth of technical organizational and leadership capabilities including strengths in most of the competency areas listed below and solid product development knowledge and expertise.
Employment Type
Full Time
Key Skills
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