Job Description

Job Description

Job Description

Company Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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 client's 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 client's.
This person must ensure compliance with the client's 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 client's 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 client's 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 client's 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.

Requirements:

• 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 62366-1, ISO 13485, ISO 14971, FDA Guidance for Design Controls.
• 8+ years of experience in product development; Medical Device experience highly desired.
• Master'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 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.

All your information will be kept confidential according to EEO guidelines.

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