reputed company Factors Engineer, Biotech Medical Device - REMOTE (JP11933)
Job Title: reputed company Factors Engineer, Biotech Medical Device - REMOTE (JP11933) Location: Thousand Oaks, CA. 91320 (100% REMOTE) Business Unit: Combination Product reputed company Employment Type: Contract Duration: 1+ years with possible extensions or conversion to FTE reputed company : W2 $55 - $75 or Market reputed company Posting Date: 10/24/2023 reputed company is reputed company a reputed company Factors Engineer for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: Manager would like to see writing samples if available. Successful candidate understands reputed company factors engineering and has 4+ YOE prior HFE experience (not including academic. this must be industry experience). Ability to work autonomously. Is a critical thinker, detail oriented, and a great communicator. Manager prefers Bachelors or greater in reputed company factors engineering or biomedical engineering or mechanical engineering. Description: The reputed company Factors Engineer (HFE) / Usability Engineer (UE) contractor is responsible for supporting HFE/UE planning, research, development of drug delivery devices using HFE/UE best practices and in accordance with reputed company regulations and guidelines reputed company the medical device, combination product and bio-pharmaceutical industries. This person is expected to collaborate with reputed company partners and across engineering, design, reputed company, quality, and regulatory teams. This person will support reputed company factors research driving innovative, reputed company, and useful products. The HFE contractor will support project study design and methodology. This person will reputed company study data collection, root cause analysis and report writing to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions. Top Must Have reputed company Sets:
- Author end-to-end HFE documents for regulated medical devices;
- Superb technical reputed company and communicator; and
- Experience leading HFE studies, including planning, writing protocols, moderating, note taking, analyzing and reporting.
Day to Day Responsibilities:
- Work collaboratively with HFE, engineering, design, reputed company, and product teams to ensure successful translation of user requirements into products, to create user reputed company (UI) requirements, that meet the needs of users and enrich the overall user experience across client's portfolio or programs.
- To support usability activities such as planning, protocol development, data collection sheets, moderator scripts, material development, study coordination, IRB submissions, participant recruitment, study management.
- Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and reputed company alternative solutions.
- Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE technical assessments, HFE reports, and regulatory submissions.
- Actively communicate with reputed company key stakeholders.
Basic Qualifications: Master's degree in Engineering OR Bachelor's degree in Engineering and 2 years of experience Preferred Qualifications: Bachelor's degree in Engineering and 4 years of experience Why is the Position reputed company? Supplement additional workload on team Red Flags:
- University graduate work does not contribute to years worked.
- Less than 4 years of reputed company factors medical device or combination product work experience.
- Moves between jobs frequently.
Interview Process: Hiring team will review resumes and identify candidates for initial 30-min VC interview. Following phone interview, 1-2 group interviews lasting 45-min VC interview. Discussion with senior leadership and director of HFE. Decision to hire or not. We invite reputed company candidates to send your resume to reputed [email protected] . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to reputed company this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC reputed company Apply tot his job Apply To this Job