Human Factors Engineer – Device Development Position Available In South Central Connecticut Planning Region, Connecticut

Job Description:

ONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING

REIMBURSEDParticipate in the Human Factors / Usability Engineering forpipeline combination products as well as lifecycle management. Thisposition will manage the human factors deliverables, overall userinterface evaluation, study design, development of labeling,integration of user needs, use risk analysis and HF vendorselection. This role will interact with multiple functional teamsincluding Clinical, Global Drug Safety, Marketing, Quality, andRegulatory, from clinical development through registration andcommercial support. This is what you will do: This position willserve the role of Sr Engineer 2 for Human Factors of Alexioncombination products within Global Product Development function ofAlexion. The candidate will participate in the Human Factors /Usability Engineering for pipeline combination products as well aslifecycle management. This position will manage the human factorsdeliverables, overall user interface evaluation, study design,development of labeling, integration of user needs, use riskanalysis and HF vendor selection. This role will interact withmultiple functional teams including Clinical, Global Drug Safety,Marketing, Quality, and Regulatory, from clinical developmentthrough registration and commercial support.

You will beresponsible for:

Lead and support activities under the humanfactors and usability engineering process for combination productdesign and development from feasibility, clinical developmentthrough registration and post-market. Member of device developmentteam responsible for determining the strategy for human factors/usability engineering activities from formative studies to final HFvalidation for combination products. Lead user related riskanalysis for the programs under development. Conduct competitiveanalysis, market sensing, complaint handling to inform new productdesign (inclusive of device, labeling and secondary packaging)Educate team members and other internal stakeholders on the HumanFactors development process and approach Interface with HFconsulting firms for their capability and build alliances with peerHF professionals throughout the industry for HF/ usability bestpractice benchmarking. Communicate effectively, both verbally andin writing, internally across departments and with externalsuppliers. Ensure all human factors engineering comply with theCompany’s quality assurance requirements as well as applicableregulatory requirements.

You will need to have:

Experience incommercialization of medical device and/or combination products.

Deep knowledge of regulatory and compliance requirements for devicerisk management and human factors/usability engineering forcombination product. Working experience in phase-based designcontrol activities with integrated risk management deliverables andhuman factors/usability engineering studies, from research throughregistration, launch and life cycle management. Demonstratedability to facilitate the interface among the pharmaceuticalcompany, 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 roficientin writing internal reports, project summaries, andinternal/external presentations. Deep knowledge of humanfactor/usability engineering, safety, performance and regulatorycompliance (EU and FDA) requirements of medical device andcombination products (e.g.

IEC 62366, ISO 11608

series, ISO 14971,IEC 60601 series, FDA

QSR 21 CFR

Part 4 and 820/ISO13485 qualitysystem requirements, and related FDA HF guidance).

[Foroffice-based positions:

] . As is typical of an office-based role,employees must be able, with or without an accommodation to: use acomputer; engage in communications via phone, video, and electronicmessaging; engage in problem solving and non-linear thought,analysis, and dialogue; collaborate with others; maintain generalavailability during standard business hours. We would prefer foryou to have: Bachelor’s in Engineering (Human Factors, Biomedical,Mechanical, Electrical Engineering, or Chemical) plus 10 to 12years experience or Master’s / Doctorate in Engineering (HumanFactors, Biomedical, Mechanical, Electrical Engineering, orChemical) plus 8 to 10 year experience in medical devicedevelopment in Ergonomics and Human Experience with injector basedcombination product preferred