AAMI

60 Aami Jobs Hiring Near You

ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7. * Knowledge of environmental monitoring requirements for manufacturing of a terminally sterilized device per ISO 14644 series ...

ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7. * Knowledge of environmental monitoring requirements for manufacturing of a terminally sterilized device per ISO 14644 series ...

The Educator will follow management direction and ensure that all SPD policies and procedures are following CMS, TJC, DHS, AAMI, and CDC standards. Ensures that all policies and procedures and ...

Decontaminated, cleaned, inspected, assembled, sterilized, and distributed surgical instruments and medical equipment according to AAMI, AORN, and hospital infection control standards. * Operated ...

Biomed Engineering Tech

San Diego, CA ยท On-site

$26 - $34.50/hr

AAMI CABT or AAMI CBET certifications * CompTIA A , CompTIA Net or equivalent certifications * Proficient and knowledgeable with applicable regulatory requirements. CMS-TJC-NFPA-HIPAA, etc.

Showing results 41-60

Human Factors Engineer / Quality Engineer / Risk Management Engineer / Usability Engineer

ICONMA, LLC

Remote

Full-time

Re-posted 6 days ago


Job description

Our Client, a American Biotechnology company, is looking for a Human Factors Engineer / Quality Engineer / Risk Management Engineer / Usability Engineer for their Remote location.
Responsibilities:
  • Support remediation of usability related risk analysis documentation, including revising, editing and reformatting, collating and tracing of task analysis and usability risk analysis document content.
  • Support definition, release and maintenance of usability related design inputs documentation.
  • Create and maintain tracing documentation with the Polarion tracing environment to Identify and resolve tracing conflicts and design input orphans in tracing between risks and design inputs/risk controls.
  • Using client laptop, software and administrative systems.
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Requirements:
  • Minimum Education: BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field.
  • Minimum of 5 years of related experience with a bachelorโ€™s degree in engineering, and have experience design controls, risk remediation, and risk analysis related medical device product development (or related field).
  • Experience working with Digital project collaboration tools is required. (e.g. Polarion, Agile PDM, Smartsheets etc.).
  • Background and understanding of MDR regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).
  • Excellent verbal communication and presentation skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms).
  • Medical device experience mandatory, no exceptions.
  • Hands-on experience with remediation of risk assessment documents.
  • Design controls and risk analysis background.
  • Human factors methodologies.
  • Regulatory knowledge (IEC 62366, AAMI HE75, FDA human factor).
  • Traceability/PLM tools (Polarion, Windchill, Agile PDM, or equivalent).
  • Preferred: 5โ€“8 years
  • Flexible up to 15โ€“20 years โ€” as long as the candidate can keep pace with the work.
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Why Should You Apply?
  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities

ICONMA logo

About ICONMA

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ICONMA is an established and stable organization building lasting relationships with clients and consultants. We are unique in our ability to provide a full spectrum of Staffing Services and Solutions including: Staff Augmentation (Contract, Contract-to-Hire, Direct Hire), Bulk Buy Staff Augmentation, Offshore Staff Augmentation, Payroll Services and Consulting (Project Delivery, SOW). At ICONMA, our goal is to become a one-stop destination for our customers' staffing and outsourcing needs. Our vision is to be a preeminent provider of innovative business solutions, leveraging key technologies to improve our customers' competitiveness, growth, and profitability. ICONMA focuses on a culture that fosters collaboration and team work. We recognize that employees are the foundation of any company, and we encourage our employees to be leaders while providing continuous training and growth opportunities. ICONMA encourages hard work, determination and dedication in a professional environment. ICONMA promotes a healthy work-life balance, and understands this is a key component to our employee's and company's success.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Troy, MI, US

Year founded

2000