Scientist Senior Job Boston area,Massachusetts USA,Engineering

Shift: Standard Working Hours. 100% Remote | Prefer PST

Job Description:

In this vital role, you will contribute to and facilitate HF/UE research, development and continuous improvement activities for drug delivery device interface systems.
To perform these activities, you will employ HF/UE standard processes in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries.
As an HF/UE, you must effectively collaborate with internal and external partners including marketing, engineering, risk, quality, safety, manufacturing, and regulatory teams.
As an HF/UE, you will drive the creation of innovative and intuitive products for patients and users; you will support appropriate human factors and usability engineering activities to ensure the product user interface-design adequately supports safe and effective use.
Will ask participant to share writing examples in advance(they may redact any sensitive information as needed) and will ask participant to perform a live critical thinking/technical writing exercise during the interview.

Top 3 Must Have Skill Sets:

Very strong written communication skills with evidence of successful health authority past approvals (Validation Report, Summary Report, URRA examples).
Critical thinking skills.
Technical problem solving skills.

HF/UE Role Responsibilities:

Partner multi-functionally with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, and commercial to ensure products are safe and effective for end users.
Support appropriate human factors and usability engineering activities to improve the design of products, specifically the user interface, including the device, packaging, labeling, and use instructions.
Implement a risk-prioritized approach appropriate for HF/UE activities.
Ensure Human-system capabilities and limitations are accurately considered, evaluated and reflected in system requirements, and HF/UE input is provided across functions to develop device design, packaging, labeling, and training requirements.
Analyze objective and subjective data from usability studies to inform design and risk assessment activities, as well as provide alternative patient and user solutions.
Moderate and/or support note taking and analysis of study data for formative and summative studies.
Prepare documentation to support development activities and design controls including usability plan, context of use, use specification, task analysis, use-related risk analysis, usability technical assessments, HF formative reports, and HF validation reports.
Communicate regularly with key internal and external partners.
This position requires up to 10-15% yearly domestic travel in the US.

What we expect of you:

The highly organized professional we seek is a problem solver and has the requisite training and experience to be an effective contributor and team member.

Basic Qualifications:

Bachelor’s or master’s degree in human Factors, Human Factors Engineering /Usability Engineering, Medical Device, Mechanical Engineering, Industrial Design, Biomedical or Systems Engineering, or other relevant engineering field and 3-5 years of industry experience, working in multifunctional, fast-paced corporate environments.
HF experience in the design and manufacturing of injectable devices (e.g., auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive/minimally invasive drug delivery systems (e.g., pulmonary, transdermal)
HF/UE experience planning, coordinating, conducting, analyzing, reporting formative human factors studies without vendor support.
Experience with various HF methodologies such as ethnographic research, one-on-one interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, heuristic and expert analysis, task analysis, hazard analysis, risk assessment, formative and summative studies.
Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features,…