Senior Engineer II - Human Factors, Device Development

US$45 - US$55 per hour + Highly Competitive Salary
  1. Contract
  2. Design, Project Engineering, Operations Management
  3. United States
New Haven, USA
Posting date: 31 Jan 2024
EN.JB.58698

Senior Engineer II - Human Factors, Device Development - Contract - Onsite

Proclinical Staffing is seeking a Senior Engineer II - Human Factors, Device Development to join a cutting-edge biopharmaceutical company. This is a contract role located in New Haven, CT.

The Senior Engineer II - Human Factors, Device Development will:

  • Experience in commercialization of medical device and/or combination products.
  • Deep knowledge of regulatory and compliance requirements for device risk management and human factors/usability engineering for combination product.
  • Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch and life cycle management.
  • Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms.
  • Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations.
  • Deep knowledge of human factor/usability engineering, safety, performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements, and related FDA HF guidance).

If you are having difficulty in applying or if you have any questions, please contact Jay Bastien at (+1) 857-254-1065 or j.bastien@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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