Human Factors / Usability Engineering

Innova Solutions is immediately hiring for a Human Factors / Usability Engineering
Position : Type: Full Time, Contract
Duration : 6+ Months
Location:New Heaven, CT or Boston, MA
As a Human Factors / Usability Engineering, your responsibilities::

• Lead and support activities under the Human Factors and Usability Engineering process for combination product design and development from feasibility, clinical development through registration and post-market.
• Member of device development team responsible for determining the strategy for Human Factors/ Usability Engineering activities from formative studies to final HF validation for combination products.
• Lead user related risk analysis for the programs under development.
• Conduct competitive analysis, market sensing, complaint handling to inform new product design (inclusive of device, labeling and secondary packaging)
• Educate team members and other internal stakeholders on the Human Factors development process and approach
• Interface with HF consulting firms for their capability and build alliances with peer HF professionals throughout the industry for HF/ usability best practice benchmarking.
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
• Ensure all Human Factors engineering comply with the Companys quality assurance requirements as well as applicable regulatory requirements.

You will need to have:

• Experience in commercialization of medical device and/or combination products.
• Deep knowledge of regulatory and compliance requirements for device risk management and Human Factors/Usability Engineering for combination product.
• Working experience in phase-based design control activities with integrated risk management deliverables and Human Factors/Usability Engineering studies, from research through registration, launch and life cycle management.
• Demonstrated ability to facilitate the interface among the pharmaceutical company, the medical device vendors, and HF consulting firms.
• Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations.
• Deep knowledge of human factor/Usability Engineering, safety, performance and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements, and related FDA HF guidance).
• [For office-based positions:]. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Bachelor's in engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 10 to 12 years' experience or

• Masters / Doctorate in Engineering (Human Factors, Biomedical, Mechanical, Electrical Engineering, or Chemical) plus 8-to-10-year experience in medical device development in Ergonomics and Human Experience with injector based combination product preferred

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Thank you!
Obulesu Arikotam
obulesu.aikotam@innovasolutions.com
(+1) 713-636-5937
PAY RANGE AND BENEFITS:
Pay Range*: Between $53 to $55 Per Hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.