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Full-time
bachelor degree, postgraduate degree
Posted 14d ago
~40 hrs/week
Responsibilities
Lead human factors and usability engineering activities in compliance with FDA, IEC, and ISO standards to develop HFE files and validation reports. Translate user needs into design requirements and manage the identification and mitigation of use-related hazards.
Requirements
Requires a Bachelor's degree in Engineering, Psychology, or Human Factors with at least 8 years of experience in regulated industries, specifically medical devices. Must have experience leading cross-functional teams and a strong understanding of FDA and IEC 62366-1 guidelines.
Full job description
Location: Onsite
Status Type: Full Time
QUALIFICATIONS:
Required:
Bachelor of Science in Engineering, Industrial Design, Psychology, or Human Factors
Minimum 8 years of experience in a regulated industry, preferably at least 5 years in medical devices, pharmaceuticals, and/or combination products
Experience in product or process development activities/process
Minimum 2 years of experience leading cross-functional, matrixed teams
Experience leading usability studies and analyzing qualitative and quantitative data; strong understanding of user centered design principles
Experience directly interfacing with external customers; experience directly managing contractors/consultants
Experience in additional functional areas (e.g., quality, regulatory, project management, manufacturing, engineering, or marketing research)
Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
Experience with FDA human factors guidance and IEC 62366-1
Proficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)
Preferred:
Master of Business Administration (MBA) or Master of Science in Engineering, Industrial Design, Psychology, or Human Factors (Preferred)
Experience organizing resources, people, budget, milestones, and detailed activities for large-scale projects
Experience managing people directly
Skills & Competencies:
Leads cross-functional stakeholders and team, directly or indirectly, including driving accountability and responsibility for results and forward progress; facilitates teamwork and exhibits self-motivation
Collaborates effectively with diverse stakeholders; demonstrates partner commitment and customer orientation
Communicates effectively in writing, including ability to write in a clear, concise, logical, and grammatically correct manner
Seeks to understand when listening to others; demonstrates awareness of what is requested; communicates orally in a professional manner that inspires confidence
Exercises discernment in dissemination of information and sense of urgency; escalates issues to ensure timely and relevant responses; demonstrates ability to handle sensitive information with discretion and tact
Demonstrates high attention to detail; conveys excellence in partner deliverables
Distills complicated topics for intended audience; leads large discussions, and adjusts/adapts/responds to real-time feedback; communicates human factors information to audience and captures real-time feedback
Executes strategic plans and workstreams, including planning, organizing, securing, and managing resources to achieve goals
Solves problems, including providing clarity in defining problem statements in ambiguous, complex situations; draws logical conclusions
Sets clear goals, delegates effectively, and leverages the skills and expertise of others
Influences without direct authority; maintains rational and objective demeanor when faced with stressful situations
Physical Requirements:
Ability to remain in a stationary position for extended periods of time
Ability to constantly operate a computer and other office equipment e.g., printer, telephone, etc.)
Ability to work in an open office environment, on-site at an Enable location
RESPONSIBILITIES:
Lead human factors and usability engineering activities in compliance with FDA, IEC, and ISO standards (including FDA HF Guidance, IEC 62366-1, and ISO 14971); develop and maintain Human Factors Engineering (HFE)/Usability Engineering Files
Lead formative usability studies, contextual inquiries, user interviews, and task analyses either directly or through an agency; lead and moderate summative (validation) usability studies, including protocol development and reporting (either directly or through an agency)
Translate user needs, workflows, and pain points into actionable design inputs and requirements; lead the discussion with engineering, quality, and regulatory teams to influence device design and labeling
Lead the creation, review, maintenance and harmonization of Instructions for Use (IFU); ensure IFU content accurately reflects validated user workflows, risk mitigations, warnings, and regulatory requirements; manage IFU updates through design changes and post-market feedback
Lead the team in the identification, analysis, and mitigation of use-related hazards and risks; execute risk management documentation; ensure traceability between user needs, hazards, mitigations, and design solutions
Provide human factors input during design reviews, design changes, and risk assessments; support design transfer and post-market activities related to usability and user feedback
Standardize and harmonize the inputs towards and review human factors documentation for regulatory submissions (e.g., 510(k), PMA, CE Mark); support interactions with regulatory bodies and respond to usability-related questions or deficiencies
Identify and drive best practices on programs/projects; ensure consistency and thoroughness of deliverables
Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as key contact for program; establish credibility with pharma partner
Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work independently
Leverage team skills and experience to achieve human factors goals; communicate clear expectations to team members in order to meet deadlines
Identify and help resolve business and process issues; drive a culture of quality and continuous improvement
Implement necessary changes to maintain compliance with new and changing processes on programs/projects
Model teamwork, diversity, and inclusion within team, between teams and other groups
Operate effectively in a dynamic start-up environment; be willing to lead tasks outside of immediate responsibilities to contribute to overall team success
Be inquisitive; foster curiosity; seek to understand the "why" behind processes and ideas and be a role model of change towards improving them
Related keywords
Human FactorsUsability EngineeringFDAIEC 62366-1ISO 14971ISOMDDMedical DevicesPharmaceuticalsCombination Products510(k)PMACE MarkUser Centered DesignRisk MitigationDesign Transfer
Enable's body-worn enFuse® drug delivery technology delivers large volumes (5 - 25mL) via subcutaneous administration.
Industry
Medical Equipment Manufacturing
Company size
201-500 employees
Founded
2010
Headquarters
Cincinnati, Ohio
LinkedIn followers
8,906
Total funding
$352M
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers large-volume therapeutics via subcutaneous administration, with the aim of improving convenience, potentially supporting improved safety outcomes, and advancing healthcare system economics. For more information, please visit www.enableinjections.com.
*The enFuse System has received device marketing authorizations from several ex-U.S. regulatory authorities. Combination product approval with a specific drug granted in the U.S. More information: enableinjections.com/approvals
Offices: 2863 East Sharon Road, Cincinnati, Ohio 45241, US
combination productpatient-centric technologysubcutaneous drug deliveryhigh-viscositywearable drug delivery devicelarge volume drug delivery deviceenFuseon-body infusorwearable injectorinjector
Based on 2003 listings with disclosed salaries, most healthcare jobs in Ohio pay between $60k–$150k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in Ohio right now?
There are currently 21,245 open healthcare positions in Ohio listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Ohio?
Companies currently hiring include Bon Secours Mercy Health, CVS Health, University Hospitals, Cleveland Clinic, TriHealth, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Ohio?
Yes — 1745 of the 21245 open healthcare positions offer remote or hybrid work (813 remote, 932 hybrid).
How do I apply for Healthcare jobs in Ohio?
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