Human Factors Research Manager, Paterson
Human Factors Research Manager, Paterson
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Paterson, USA
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Posted: 06/08
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Description
Our client, a leading Medical Devices Manufacturing Company is looking for Human Factors Research Manager and This is for an initial duration of 03 Months Contract – Remote Role
Job Title: Human Factors Research Manager
Job Id: (phone number removed)
Location: Remote Role
Duration: 03 Months Contract
Position Type: Hourly Contract Position (W2 only)
Human Factor Lead
Type: Part-Time
Hours Per Week: 25 hours + (Could be more)
Work Style: Remote
Hours in Work Week: EST
Estimated End Date: End of September 2025
Work Schedule: 9am - 5pm
Role
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 Client procedures.
The Senior Manager will lead a Human Factor reviews 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 Client.
This person must ensure compliance with Client 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 Client safety regulations, policies, and procedures.
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 Client 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 Client 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
Experience and Education
Minimum of a Bachelor's 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 HF+UXD 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 (phone number removed), 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 (phone number removed), 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.
Compensation: The hourly rate for this position is between $68-$72 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Qualified candidates please send your word format updated resume at the earliest to Pavan: [(phone number removed)] OR Sangeeth: [(phone number removed)]
Thank You.
Job Title: Human Factors Research Manager
Job Id: (phone number removed)
Location: Remote Role
Duration: 03 Months Contract
Position Type: Hourly Contract Position (W2 only)
Human Factor Lead
Type: Part-Time
Hours Per Week: 25 hours + (Could be more)
Work Style: Remote
Hours in Work Week: EST
Estimated End Date: End of September 2025
Work Schedule: 9am - 5pm
Role
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 Client procedures.
The Senior Manager will lead a Human Factor reviews 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 Client.
This person must ensure compliance with Client 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 Client safety regulations, policies, and procedures.
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 Client 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 Client 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
Experience and Education
Minimum of a Bachelor's 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 HF+UXD 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 (phone number removed), 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 (phone number removed), 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.
Compensation: The hourly rate for this position is between $68-$72 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Qualified candidates please send your word format updated resume at the earliest to Pavan: [(phone number removed)] OR Sangeeth: [(phone number removed)]
Thank You.
Highlights
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Company nameSunrise Systems Inc
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Job positionHuman Factors Research Manager
More details
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This is a part-time job.
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