Human Factors Engineer - client dedicated at Thermo Fisher Scientific

Ware, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biopharmaceuticals, Medical DevicesIndustries

Requirements

Graduate in Mechanical Engineering, Biomedical Engineering or related degree (i.e: Psychology)
Practical experience and knowledge of human factors and usability regulatory framework, including FDA guidance, IEC 62366 and ANSI/AAMI HE75 and expectations for medical devices/combination products
Experience on the development, manufacture and integration of end user inputs (user needs and risk related scenarios) of medical devices/combination products
Working experience in product development and design validation as well as in the regulatory pathways for combination products (e.g. global submissions, agency interactions and authoring dossiers)
Ability to analyse and summarise data and translate them into devices/combination products design recommendations
Excellent written and verbal communication skills as well as great attention to detail
Strong time management/organisational skills
Evidence of team working skills and flexibility
Experience with combination product and/or parenteral device development would be beneficial

Responsibilities

Provide inputs for human centred design engineering for a range of projects across all phases of development
Effectively communicate your work to the wider development team and stakeholders
Be involved in problem solving and utilisation of different strategies to support resolution of design, risk and regulatory challenges
Support the execution of early patient handling studies (formative studies), identification and maintenance of user needs, conducting user related risk assessments, planning and execution of design validation activities
Ensure user needs are considered early and continuously throughout the design process
Support the interface between the external vendors and the Human factors Team
Management of external HF vendors
Support the development and population of the Design History File as it pertains to design Validation
Author sections of regulatory files

Skills

Key technologies and capabilities for this role

Human Factors EngineeringHuman Centred DesignFormative StudiesPatient Handling StudiesUser Needs IdentificationRisk ManagementRegulatory ComplianceProblem Solving

Questions & Answers

Common questions about this position

What is the location for this Human Factors Engineer role?

The role is based at the client's R&D site in Ware, Hertfordshire, UK.

What education and experience are required for this position?

A graduate degree in Mechanical Engineering, Biomedical Engineering, or related field like Psychology is required, along with practical experience in human factors and usability regulatory frameworks such as FDA guidance, IEC 62366, and ANSI/AAMI HE75, and experience in medical device development, user needs, and design validation.

What is the salary or compensation for this role?

This information is not specified in the job description.

What is the work schedule and employment type?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What makes a strong candidate for this Human Factors Engineer role?

Candidates with a relevant graduate degree, hands-on experience in human factors regulations for medical devices/combination products, and proven skills in user needs integration, design validation, and product development will stand out.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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