HUMAN FACTORS ENGINEER - DEVICE DEVELOPMENT
Company: Nesco Resource
Location: New Haven
Posted on: October 29, 2024
Job Description:
ONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED
Ensure all your application information is up to date and in order
before applying for this opportunity.
Participate in the Human Factors / Usability Engineering for
pipeline combination products as well as lifecycle management. This
position will manage the human factors deliverables, overall user
interface evaluation, study design, development of labeling,
integration of user needs, use risk analysis and HF vendor
selection. This role will interact with multiple functional teams
including Clinical, Global Drug Safety, Marketing, Quality, and
Regulatory, from clinical development through registration and
commercial support.
This is what you will do:
This position will serve the role of Sr Engineer 2 for Human
Factors of Alexion combination products within Global Product
Development function of Alexion. The candidate will participate in
the Human Factors / Usability Engineering for pipeline combination
products as well as lifecycle management. This position will manage
the human factors deliverables, overall user interface evaluation,
study design, development of labeling, integration of user needs,
use risk analysis and HF vendor selection. This role will interact
with multiple functional teams including Clinical, Global Drug
Safety, Marketing, Quality, and Regulatory, from clinical
development through registration and commercial support.
You will be responsible for:
- 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 Company's
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. P roficient
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 Master's / 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
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Keywords: Nesco Resource, Bayonne , HUMAN FACTORS ENGINEER - DEVICE DEVELOPMENT, Engineering , New Haven, New Jersey
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