Engineer III, Systems Design at Thermo Fisher Scientific

Birmingham, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Life SciencesIndustries

Requirements

Bachelor’s or equivalent experience in Engineering or Science (Biomedical, Electrical, Mechanical, Software, Physics or related field)
5+ years of experience in systems engineering or a related field
Knowledge of regulatory standards and guidelines relevant to medical devices (Preferred)
Proficiency in system development, implementation, and maintenance
Ability to develop customer-focused concepts to meet technical requirements
Excellent analytical and problem-solving skills
Ability to diagnose complex software and hardware issues
Strong verbal and written communication skills, with the ability to convey technical information to non-technical collaborators
Proven track record to work effectively in a team environment and lead multi-functional projects
Ability to adapt to changing technologies and methodologies in a fast-paced environment

Responsibilities

Gather and assess user and collaborator needs for medical device systems
Translate requirements into detailed system specifications and compose documents
Develop and pioneer innovations in medical device systems, while adhering to regulatory guidelines (e.g., FDA, ISO 13485)
Conduct and lead development reviews, providing input on system architecture, composition, and functionality
Develop and maintain comprehensive system-level documentation, including requirements specifications, composition documents, and interface control documents
Perform system-level testing and validation to ensure device performance and safety
Identify and resolve intricate technical issues concerning medical device systems
Participate in and lead risk management activities, including hazard analysis and failure mode effects analysis (FMEA)
Provide technical support and training to manufacturing and service teams
Follow the latest industry trends, technologies, and regulatory changes
Lead and manage system engineering projects, ensuring timely delivery and alignment to specifications
Mentor and guide junior engineers, encouraging their professional growth
Report progress and issues to senior team members and management
Collaborate with assay development, software engineers, hardware engineers, quality assurance, and regulatory affairs to ensure successful project outcomes
Work closely with other departments to ensure seamless integration and functionality of systems
Ensure traceability of verification activities to requirements and risk management documentation
Preserve comprehensive documentation of all system engineering actions and achievements

Skills

Systems Engineering

Medical Devices

FDA

ISO 13485

Requirements Engineering

System Architecture

Risk Management

FMEA

Hazard Analysis

System Testing

System Validation

Interface Control Documents

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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