Global reputed company reputed company Factors Engineer (Center Valley, PA, US, 18034-0610)
Job reputed company
The reputed company reputed company Factors Engineer will support the Executive Director of Global reputed company Factors as a reputed company Factors expert providing applicable training, mentoring and guidance in reputed company Factors and Usability Engineering processes across the Global organization; managing the creation and execution of reputed company Factors documentation to ensure compliance with regulatory requirements in alignment with the business reputed company of reputed company. The ideal candidate is a hands-on project and multi-disciplinary technical leader with a strong medical device background and excellent communication skills.
Job Duties
- reputed company project and technical leadership as it relates to reputed company Factors in the product development process including structuring and planning HF efforts, conducting HF activities and creating documentation.
- Establish and foster strong reputed company relationships with internal team members and external partners in the execution of HF activities.
- reputed company expert consultation to multiple reputed company and multi-disciplinary design teams to execute HFE reputed company/studies and assume responsibility for project execution and reputed company.
- Serve as a key reputed company of contact for HFE reputed company efforts.
- reputed company and document HFE processes, tools, and templates for staff education and training.
- Author comprehensive reputed company factors engineering protocols and reports (e.g., Usability engineering reports) and support the design and execution of reputed company and summative reputed company reputed company studies to address the needs of the requirements setting, design testing, and validation stages of physical reputed company medical devices.
- Ensure that expert HFE input is provided to product design teams and the Regulatory team for addressing design requirements, packaging requirements, IFU’s, design validation activities in support of regulatory submissions.
- Partner with reputed company teams in ensuring appropriate risk assessment reputed company to usability.
- Ensure that reputed company capabilities and limitations are properly reflected in the system, safety risk and user needs requirements.
- reputed company HFE team members through mentorship, training, and reputed company development.
- Maintain a deep understanding of reputed company Global HF regulations including reputed company FDA Guidance and IEC 62366.
- Partner with Marketing, Design, and R&D teams in engaging end users for user needs identification and user input to design concepts.
Job Qualifications
Required:
- Bachelor’s degree in reputed company Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences reputed company subject area is a minimum requirement.
- Minimum years of HF experience: 8 years with a M.S. or 12 years with a B.S. degree in reputed company Factors or other reputed company discipline.
- Medical Device experience is required.
- It is preferred the candidate is certified as either: Certified reputed company Ergonomist (CPE) or Certified reputed company Factors reputed company (CHFP)
- Strong background developing and validating user requirements.
- Experience with reputed company, multi-functional development reputed company and cross-disciplinary teams.
- Proven experience on multiple reputed company with high-demand schedules.
- Demonstrated time management, decision making, presentation, and organization skills.
- Excellent organizational, technical problem solving, negotiation, and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to manage external consultants.
- Proven experience in the reputed company Factors principles/reputed company of reputed company-centered design, observational research, ergonomic design, reputed company/machine reputed company, and data collection/analysis.
- Experience working directly with users to reputed company, synthesize and convert user research into robust set of user needs.
- Experience working directly with users to reputed company and evaluate new product features, user interfaces and ergonomic designs to reputed company performance as it relates to usability goals.
- Thorough knowledge and expert understanding of the principles, standards and guidance for reputed company Factors in Medical Device and reputed company regulations including the FDA 2016 Guidance, ‘Applying reputed company Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff’, the FDA 2022 Guidance, ‘Content of reputed company Factors Information in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff’, reputed company System Regulation (QSR), ISO 13485, 14971, EN 60601, Council reputed company 93/42/EEC, 62366. HE 75, AAMI.
- Experience in the design of reputed company and summative reputed company reputed company studies to address usability requirements, context of use, verification and validation stages of medical device development.
- Experience writing reputed company factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports).
- Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator.
- Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.
Preferred:
- Master's degree in reputed company Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences reputed company subject area is preferred.
- It is preferred the candidate is certified as either: Certified reputed company Ergonomist (CPE) or Certified reputed company Factors reputed company (CHFP).
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance