Technology Engineer

2 weeks ago

New Haven, United States Apollo Professional Solutions Full time
Job Description

Technology Engineer
New Haven CT*
Contract
Pay Rate:$53.33/Hr.
Benefits: parking reimbursable, medical, dental, vision, 401k
*on-site 3 days per week

Requirements:Technology Engineer
  • US Citizenship
  • Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-market.
  • Member of device development team responsible for determining the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.
  • Lead user related risk analysis for the programs under development.
  • Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
  • Educate team members and other internal stakeholders on the Human Factors development process and approach
  • Interface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking.
  • Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
  • Ensure all human factors engineering comply with the Company's quality assurance requirements as well as applicable regulatory requirements.
Job Description: Technology EngineerThis position will serve the role of Sr Engineer 2 for Human Factors. The candidate will participate in the Human Factors / Usability Engineering for pipeline combination products as well as lifecycle management. This position will manage the human factors deliverables, overall user interface evaluation, study design, development of labeling, integration of user needs, use risk analysis and HF vendor selection. This role will interact with multiple functional teams including Clinical, Global Drug Safety, Marketing, Quality, and Regulatory, from clinical development through registration and commercial support.
Responsibilities:Technology Engineer
  • Lead and support activities under the human factors and usability engineering process for combination product design and development from feasibility, clinical development through registration and post-market.
  • Member of device development team responsible for determining the strategy for human factors/ usability engineering activities from formative studies to final HF validation for combination products.
  • Lead user-related risk analysis for the programs under development.
  • Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging).
  • Educate team members and other internal stakeholders on the Human Factors development process and approach.
  • Interface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking.
  • Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
  • Ensure all human factors engineering complies with the Company's quality assurance requirements as well as applicable regulatory requirements.
Preferred Education & Experience:Technology Engineer
  • Bachelor's in engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 years' experience or Master's / Doctorate in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus,
  • 8 to 10 year experience in medical device development in Ergonomics and Human Experience with injector-based combination product preferred.
71451

EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.

Meet Your Recruiter

David Beaver

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