Scientist Senior

Aditi Consulting

Boston, MA

JOB DETAILS
SALARY
$43–$45 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Automotive Automation, Biomedical Engineering, Communication Skills, Consulting, Contextual Inquiry, Cross-Functional, Customer Conversion, Customer/Client Research, Data Analysis, Design Verification, Drug Delivery Systems, Drug Products, Ergonomics, Establish Priorities, Focus Groups, Hazard Analysis, Healthcare Quality, Human Factors, Industrial Design, Manufacturing, Mechanical Engineering, Medical Equipment, Medical Products, Messaging Technology, Organizational Skills, Problem Solving Skills, Product Design, Product Packaging, Product Testing, Prototyping, Purchasing/Procurement, Regulations, Risk, Risk Analysis, Short Messaging Service (SMS), Speech Technology, State Laws and Regulations, Support Documentation, Systems Engineering, Team Player, Technical Analysis, Telephony, Usability Engineering, User Interface Design, User Interface/Experience (UI/UX), Validation Testing, Willing to Travel, Writing Skills
LOCATION
Boston, MA
POSTED
30+ days ago
Payrate: $43.00 - $45.00/hr.
 
Summary:
The position requires strong written communication skills, critical thinking skills, organizational skills, technical problem-solving skills, the ability to work in teams, the ability to adapt to a rapidly changing environment, and the desire to contribute to meaningful and innovative products.
 
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.
 
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, user interfaces and ergonomic designs.
  • Experience evaluating low and high-fidelity prototypes to identify and eliminate potential use errors early in the development process.
  • Experience working in development organizations, particularly virtual development environments.
  • Experience working within the development of systems, including design, verification, and validation.
  • Functional knowledge and experience in the practical application of relevant guidance, regulations and standards.
 
Must Have Skill:
  • Very strong written communication skills with evidence of successful health authority past approvals (Validation Report, Summary Report, URRA examples);
  • Critical thinking skills; and
  • Technical problem-solving skills.
 
Pay Transparency: The typical base pay for this role across the U.S. is: $43.00 - $45.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
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About the Company

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Aditi Consulting