Human Factors and Design Control Engineer
Job Opportunity at Clinical Dynamix, Inc.

Posted on May 24

http://www.clinicaldynamix.com    561-732-4505

Location: Waltham, MA
Job Type: Full Time
Job ID: W4158166

General Job Description:
This position would support drug product packaging and combination product development on cross functional teams through all phases of development.  Engineer would evaluate materials and designs, execute design verification, prepare design control documents and support usability/human factors assessments. 
Key Area of Responsibilities:
Key areas of responsibility for Human Factors and Design Control Engineer include:
  • Evaluate materials, design, and configuration of primary, secondary, and other packaging to meet usability and other packaging requirements
    • Perform system functionality testing
    • Conduct usability and ergonomic research and feasibility testing
    • Prepare materials for usability or human factors studies
  • Ensure design control documentation and requirements are met and appropriately traced throughout the development process and in the design history file
    • Conduct design verification
  • Characterize drug product and packaging material attributes and compatibilities
  • Collaborate with key stakeholders to identify functional requirements
  • Document data and records in electronic lab notebooks
  • Summarize and present data in a clear organized format that meet cross functional leader needs
  • Write and execute protocols and reports
Essential Requirements
4+ years’ industry experience within a regulated environment
2+ years’ experience with combination products or medical devices
Ability to use measurement devices and mechanical testing devices
Proven ability to work independently given high-level direction
Proficiency with Microsoft Office® products (Excel, Word, Powerpoint)
Excellent oral and written communication skills
Experience with design controls for medical devices or combination products
Experience with human factors engineering
Educational Requirements:
BS or BE in a relevant engineering discipline (i.e. material science, mechanical engineer, bioengineering, human factors engineering, industrial design)
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