Senior Human Factors Engineer Instructions For UseMedical Device Remote JP13164
Senior Human Factors Engineer Instructions For UseMedical Device Remote JP13164
Posted on :
10-04-2025
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1 Vacancy
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Monthly Salary
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Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
Job Title: Senior Human Factors EngineerSenior Human Factors Engineer Instructions For Use/Medical Device Remote (JP13164 Remote (JP13164
Location: Thousand Oaks CA. 91320 (Remote Flexible)
Business Unit: Combination Product Excellence
Employment Type: Contract
Duration: 1 year with likely extensions and/or conversion to a permanent position.
Rate: Open Market Rate W2
Posting Date: 9/5/2024.
Notes: Only qualified candidates need apply. Must have online portfolio
3 Key Consulting is hiring! We are recruiting a Senior Human Factors Engineer for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
To be considered candidates MUST supply an online portfolio.
NOTE: This is expected to be a contract position within our clients Human Factors and Usability Engineering group working 40 hours/week. The position is for 1 year and may be renewed at the end of that period. This position can be remote or inperson at the clients Thousand Oaks CA headquarters. If the candidate is within commuting distance of Thousand Oaks they will be expected to work onsite most/all hours. There is no relocation for this position.
Top Must Have Skill Sets:
Day to Day Responsibilities:
Red Flags:
Why is the Position Open
Interview Process:
Video conference
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: Thousand Oaks CA. 91320 (Remote Flexible)
Business Unit: Combination Product Excellence
Employment Type: Contract
Duration: 1 year with likely extensions and/or conversion to a permanent position.
Rate: Open Market Rate W2
Posting Date: 9/5/2024.
Notes: Only qualified candidates need apply. Must have online portfolio
3 Key Consulting is hiring! We are recruiting a Senior Human Factors Engineer for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
To be considered candidates MUST supply an online portfolio.
NOTE: This is expected to be a contract position within our clients Human Factors and Usability Engineering group working 40 hours/week. The position is for 1 year and may be renewed at the end of that period. This position can be remote or inperson at the clients Thousand Oaks CA headquarters. If the candidate is within commuting distance of Thousand Oaks they will be expected to work onsite most/all hours. There is no relocation for this position.
- Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices. IFU creation includes copy layout and lineart illustrations.
- Develops both low (simple sketch) and highfidelity digital samples of instructional materials intended for print.
- Manages instruction design projects working closely with other designers HF engineers and other related functions.
- Supports usability studies with quick turnaround during iterative studies in a designtestrefinetest model.
- Balances design thinking with regulatory requirements during development of instructional materials.
- Develops instructions for new projects by understanding user needs with HFE partners and applying platform guidelines to create approachable useful and effective instructions for users who may be new to the therapy and drug administration.
- Maintains history records to capture rationale for changes over the development of the instructions.
- Supports process improvement initiatives including: defining and documenting current procedures within the group and working with crossfunctional partners to improve and document labeling across upstream and downstream functions.
Top Must Have Skill Sets:
- Minimum 510 years of instruction design experience including IFUs including strong proficiency in rapid sketch illustration digital lineart illustration and image (photo) editing. Proficient in Adobe Creative Suite (InDesign Illustrator Photoshop) and strong knowledge of InDesign paragraph and character styles. Understands the application of structure and grids for the development of platforms to ensure consistency in output and efficiency in process during instruction creation.
- Minimum 35 years managing design projects and/or teams.
- Medical healthcare medical devices and/or pharmaceuticals background.
- Must be punctual reliable flexible and excellent at balancing multiple detailoriented projects.
- If remote must have experience working remotely from others in team.
- Highlevel attention to detail and accuracy in reducing errors in work deliverables.
Day to Day Responsibilities:
- Create and update IFUs reference guides and carton artwork content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations industry standards and company requirements.
- Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects representing the Instruction Design group by coordinating with crossfunctional teams (including Human Factors Device Engineering Marketing Labeling Clinical Legal and Regulatory Affairs) to define instructional requirements and execute on plans.
- Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs and update platforms as appropriate.
- Maintain change history of instruction materials during their development.
- Produce low (quick sketch) to high (refined digital files) fidelity prototypes of IFUs reference guides and carton artwork for usability studies. High fidelity prototypes may require plotting trimming folding binding laminating and constructing structural cartons.
- Provide expertise and guidance to Human Factors engineering partners and other crossfunctional partners with content generation illustrations layout and formatting of instruction materials.
- Support process improvement programs and documentation of crossfunctional processes.
- Manage junior staff and/or oversee external vendors to execute design work.
- Troubleshoot relatively complex problems and issues.
Red Flags:
- Only academic experience
- Past experience exclusively in marketing branding logos websites without any experience writing instructions for regulated products
- Only juniorlevel experience designing; we need seniorlevel experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders
- Textbased instructions only (ex. SOP development without illustrations and layout personnel training manuals defense user manuals)
Why is the Position Open
Interview Process:
Video conference
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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