JOB SUMMARY
The Human Factors Engineer will conduct human factors research, analysis, and evaluation using standard human factors engineering theories, principles, and data to drive user-centered product design and development. Assignments include applying HFE to system user interface definition, design, and evaluation over the product life cycle. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, leadership opportunities, and company practices and policies.
ESSENTIAL DUTIES
Supports the strategy, planning, and execution of human factors engineering activities for various product development projects.Leads HFE work for projects with limited user interface changes with guidance from senior engineers. Conduct user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for development of user and environment profiles, use specification, use scenarios, and usability/user interface requirements.Supports usability testing and execution of human factors formative and summative evaluations.Ensures that product development projects are following HFE process compliant with all Company policies and procedures as well as existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance. Analyzes field data and reviews literature and publications to identify existing usability issues with on-market products. Works with cross-functional teams to create and maintain use-related risk analyses and user interface requirements.Contributes to prototype design builds for usability testing, including graphical user-interface, hardware, or disposable components. Supports the development of internal tools for human factors data capture, analysis, and testing.Reinforces customer empathy and human-centered design approach across the organization.Keeps abreast of regulations and best practices for medical device human factors engineering (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).OTHER DUTIES AND RESPONSIBILITIES
Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s). Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines, Product Managers, UX Designers, Product Technology Leads, Marketing, Regulatory, Project Managers, and Product Support and Training.MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related research-based degree, preferred.Experience
Minimum 3 years' experience.Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance, preferred. Experience with risk management activities applied by Human Factors to medical devices (i.e. URA, UFMEA, AFMEA, UEA techniques), preferred.Skills
Requires knowledge of product design and development process, preferably for medical devices.Working knowledge of human factors, design controls, and risk management regulations, standards, and guidance's for medical devices.Strong interactive skills in cross-functional collaboration and influence, acceptance of guidance, technical leadership, proactive communication, and accountability.Ability to influence without authority to drive user-centered design thinking and solutions.Strong technical writing skills for writing protocols and reports for regulatory submissions.Demonstrated critical-thinking and problem-solving skills.Strong interpersonal skills and ability to properly engage users and customers while not compromising research and data collection.Highly organized and able to work efficiently across multiple projects in parallel.Demonstrated ability to communicate and present data and results effectively to broad audiences. Knowledge and use of relevant PC software applications and skills to use them effectively.-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
PHYSICAL REQUIREMENTS
General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires domestic and international travel based on business needs.
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Under general direction and as a member of a scrum team, provides technical leadership in the development of software automation frameworks involving application of new technologies with significant technical risk. Develops automated software tests at all levels of the testing pyramid. Extends, enhances and maintains the software automation library and framework.
ESSENTIAL DUTIES
Defines software automation strategies and best practices.Maintains full software test automation suite, reusable software components and function libraries.Demonstrates solid computer science fundamentals such as design patterns, data structures, OOP and software design.Demonstrates expert level application of Source Code Management tools.Applies performance and security test techniques.Supports performance and security testing activities at the API/Interface level.Applies Continuous integration/ Continuous Delivery (CI/CD) techniques with chosen build pipeline tools.Effectively implements TDD techniques and creates build pipelines to support CI/CD.Develops and manages dynamic software test data creation.Organizes and controls the software testing process to help deliver high quality software.Provides technical support and mentoring to other team members.Troubleshoots environmental set-up issues related to software test automation.Approves Code/Test Reviews.Participates in all levels of testing as required.Drives discussions for determining appropriate level at which to test the implemented functionality.Demonstrates mastery of traditional white and black box software test techniques.OTHER DUTIES AND RESPONSIBILITIES
Maintains general knowledge of industry and Company regulatory and software quality standards and applies this knowledge to the completion of all projects.Responsible for oversight of the SQA/testing activities within scrum team such as, ensuring requirements are in place and are testable, writes verification plans, targets and identifies release of tests or if a new test is required, and ensures success of the team supporting the process to execute tests.Ensures release of software, writes verification reporting, performs reliability assessments, deferred issue reporting, requirements traceability, readiness statement and review, and process verification.Familiarity with GMP/CRF Part 11/IEEE/ISO 9000 standards for software quality assurance, impact/risk analysis, and software traceability.Holds self and team accountable for adherence to Agile principles and practices.Demonstrates required competencies and grow in the Leadership Competency Model.MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor's degree in Computer Science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
Minimum 5 +years experience in an SDET role.
Skills
Proficient in object-oriented programming and applications/embedded software development .NET C# ,C++, Python, Typescript/Angular 8+, T-SQL.Proficient in testing at the API level using tools like RestAssured, Postman/Swagger and at System testing using tools like Cucumber and Selenium or Protractor.Demonstrated proactive and strong problem-solving skills.Scans the environment for new technical skills, knowledge, or capabilities that can benefit business or personal performance.Has a track record of exceeding goals successfully.Provides timely and helpful information to others across the organization.Handles and manages crises effectively.Deals constructively with problems that do not have clear solutions or outcomes.Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions.-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
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We are looking for a highly skilled and experienced Senior Embedded Systems Engineer to join our dynamic team. In this role, he/ she will:
Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices. Work closely with cross-functional teams to ensure the successful integration of hardware and software components. Be responsible for optimizing system performance, ensuring reliability, and meeting project deadlines. Have a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team. Be expected to stay up to date with the latest industry trends and technologies and apply this knowledge to improve our products and processes. Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.ESSENTIAL DUTIES
OTHER DUTIES AND RESPONSIBILITIES
Work direction responsibility may include technicians and junior engineers. May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.May contribute to the establishment of business objectives, goals, budgets, and costs.MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Bachelor of Science degree or Master of Science degree in Engineering preferred.
Experience
Minimum of 5 years of experience is required for a Senior Electronics Engineer and minimum 3 years of experience for Electronics Engineer.
Minimum of 3 years of experience in the medical device field preferred for Senior Engineer and minimum 1 years of experience for Electronics Engineer.
Skills
PHYSICAL REQUIREMENTS
General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires travel based on business needs.
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