Job Description

Overview:

Our client, a global Medical Technology corporation with singular focus on Diabetes management and treatment solutions and leader in Insulin delivery products for >30 million people in >100 countries, seeks an accomplished Human Factor Lead.

*** Candidate must be authorized to work in USA without requiring sponsorship ***

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*** Location: 100% Remote (Parsippany, NJ 07054)

*** Duration: 3+ months with possible conversion

Important:

• Work Schedule: 9am - 5pm
• Part Time Role: Per week - 25-30 hours

Job Overview:

Reporting to 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. Ensure MA function has the 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 review and all related activities 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.

Required Skills:

• This person must ensure compliance with 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 client’s 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’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 clients and support pre-clinical, 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 of employees

Required Qualifications:

• 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.

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I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Sam Banga

Lead Recruiter

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

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