Nesco Resource | Human Factors Engineer
5 days ago
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
-
Nesco Resource | Human Factors Engineer
6 days ago
new haven, United States Nesco Resource Full timeONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED 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...
-
Human Factors Engineer
6 days ago
new haven, United States Nesco Resource Full timeONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED 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...
-
New Britain, United States Nesco Resource Full timeNesco Resource is seeking a CNC Programming/Manufacturing Engineer to work for one of our clients based in New Britain, CT. Responsibilties: CNC programming, turning or milling to ensure final dimensions are met Create setup sheets, tool sheets and control documentation for aerospace parts Required to create drawings for projects and products being made...
-
West Haven, United States Nesco Resource Full timeNesco Resource is looking for a Machine Operator for our client in West Haven. This is a temporary to permanent position for the right candidate!Shift: Sunday, Tuesday, Wednesday 6:30 AM – 7:30 PMResponsibilities Operates assigned blending department machine(s) in compliance with established current Good Manufacturing Practices, Standard Operation...
-
west haven, United States Nesco Resource Full timeNesco Resource is looking for a Machine Operator for our client in West Haven. This is a temporary to permanent position for the right candidate!Shift: Sunday, Tuesday, Wednesday 6:30 AM – 7:30 PMResponsibilities Operates assigned blending department machine(s) in compliance with established current Good Manufacturing Practices, Standard Operation...
-
north haven, United States Nesco Resource Full timeNesco Resource is in search of a Trade Development Manager to work for one our clients based in North Haven, CT. Summary:The Trade Development Manager will be responsible for maintaining relationships and achieving sales and GP growth with assigned suppliers and product portfolios in accordance with company goals. Evaluate and identify new product/supplier...
-
New Haven, United States Nesco Resource Full timeLocation: New Haven - College St.The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include...
-
new haven, United States Nesco Resource Full timeLocation: New Haven - College St.The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include...
-
new jersey, United States Nesco Resource Full timeOur mission in Analytics and Materials Characterization is to partner with our researchers to increase knowledge. We accomplish this by providing high quality, reliable data and solutions. The Elemental Analysis lab is a high volume and fast paced group, providing accurate elemental analysis in reasonable time.We are seeking a professional like you to...
-
New York, United States Nesco Resource Full timeNesco is seeking IMAC & Desktop Support Technicians for NYC. This is a 3 month contract opportunity. Technicians will be responsible for pre-setup and imaging on new equipment Backup, disconnect, and reconnect end users' desktops at new location Test equipment and support end users at new location for any issues that arise after IMAC The technician will...
-
New Milford, United States Nesco Resource Full timeNesco Resource is looking for an Electro-Mechanical Assembler in New Milford, CT. This is a temp to hire position for the right candidate. Schedule is: Monday- Friday from 7:00 AM to 3:30 PM (OT is Possible). Must be able to work overtime when required. Pay is $18.00-$21.00/hour depending on experience.Duties & Responsibilities: Complete general assembly...
-
state of new york, United States Nesco Resource Full timeProduction AssociateNesco Resource, a leading provider of staffing solutions, is actively seeking a motivated and reliable Production Associate to join our dynamic team. As a Production Associate, you will play a crucial role in our manufacturing operations, contributing to a positive and efficient work environment. This is an immediate opening for a day...
-
New Baltimore, United States Nesco Resource Full timeMaintenance Technician - Industrial Sewing MachinesMacomb County - Direct HireQualifications: Bachelor Degree or equivalent in Electrical Engineering coupled with 2 years experience in Industrial Sewing and Automated Equipment for heavy duty sewing applications. Proficient in Auto Cad design, knowledge and application of Electronics & Pneumatics Electronic...
-
new baltimore, United States Nesco Resource Full timeMaintenance Technician - Industrial Sewing MachinesMacomb County - Direct HireQualifications: Bachelor Degree or equivalent in Electrical Engineering coupled with 2 years experience in Industrial Sewing and Automated Equipment for heavy duty sewing applications. Proficient in Auto Cad design, knowledge and application of Electronics & Pneumatics Electronic...
-
New York, United States Nesco Resource Full timeFrom communications networks and critical national security systems to life-saving diagnostic imaging, quantum computing and more, our client supports the world's most innovative companies in building RF, microwave and millimeter wave technology. They offer a generous compensation package and benefits as well as growth opportunity. They have been...
-
North Haven, United States Nesco Resource Full timeHere’s a concise job description for a Clerical/Admin Assistant with Microsoft Office and QuickBooks skills:Job Title: Clerical/Admin AssistantLocation: [Insert Location]Position Type: Full-time/Part-timeJob Summary:We are seeking a detail-oriented Clerical/Admin Assistant to join our team. The ideal candidate will have excellent organizational skills,...
-
north haven, United States Nesco Resource Full timeHere’s a concise job description for a Clerical/Admin Assistant with Microsoft Office and QuickBooks skills:Job Title: Clerical/Admin AssistantLocation: [Insert Location]Position Type: Full-time/Part-timeJob Summary:We are seeking a detail-oriented Clerical/Admin Assistant to join our team. The ideal candidate will have excellent organizational skills,...
-
north haven, United States Nesco Resource Full timeHere’s a concise job description for a Clerical/Admin Assistant with Microsoft Office and QuickBooks skills:Job Title: Clerical/Admin AssistantLocation: [Insert Location]Position Type: Full-time/Part-timeJob Summary:We are seeking a detail-oriented Clerical/Admin Assistant to join our team. The ideal candidate will have excellent organizational skills,...
-
Nesco Resource | Paralegal
6 days ago
New York, United States Nesco Resource Full timeOpen Call for Legal Support Professionals!Are you a skilled legal professional ready to take your career to the next level? We're looking for top talent to join our network for Contract and Direct Hire Roles with leading law firms and legal departments.Open Roles Include: Paralegals (Corporate, Litigation, Personal Injury, Real Estate, and more) Legal...
-
new york city (brooklyn), United States Nesco Resource Full timeFrom communications networks and critical national security systems to life-saving diagnostic imaging, quantum computing and more, our client supports the world's most innovative companies in building RF, microwave and millimeter wave technology. They offer a generous compensation package and benefits as well as growth opportunity. They have been...
