About this opportunity
Judge Direct Placement lists this Human Factors Engineer opportunity in milford, Ohio. Review the employer’s description below for duties, qualifications and application requirements.
Job description
The Judge Group is seeking a Human Factors / Usability Engineer in the Milford, OH area with strong experience leading 6+ years of experience in medical devices or pharmaceuticals.
The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.
COMPENSATION:
160k to 175k
WORKSITE: Onsite (NO REMOTE)
RELOCATION: Available for the right candidate
MUST HAVE: BS, Human Factors, Engineering, Industrial Design
MUST HAVE: 6+ years of experience in medical devices or pharmaceuticals
MUST HAVE: ISO, FDA, MDD experience
MUST HAVE: FDA human factors and IEC 62366-1 experience
LIKE TO HAVE: MBA
MUST BE: A US Citizen or a Green Card Holder
EXPERIENCE:
- Lead Human Factors Engineering (HFE) and usability engineering activities for medical device development
- Conducting and overseeing usability studies, user interviews, task analyses, and validation testing.
- Turning user feedback into design requirements that engineering teams can implement.
- Managing risk assessments related to device use and ensuring compliance with FDA and international standards.
- Developing and maintaining Instructions for Use (IFU) documentation and regulatory submissions.
- Becomes the bridge between patients, nurses, healthcare providers, Engineering, Quality, Regulatory Affairs and pharmaceutical customers
- The position also serves as a key contact with pharmaceutical partners and influences product design decisions.
REQUIRED:
- BS, Human Factors, Engineering, Industrial Design
- 6+ years of experience in medical devices or pharmaceuticals
- 3+ year of experience in product or process development
- Experience with usability studies and analyzing associated data
- Experience interfacing with customers, contractors and consultants
- ISO, FDA, MDD experience
- FDA human factors and IEC 62366-1 experience
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.