Brendan Reinicke

Angestellt, Project Management, Brendan Reinicke

Copenhagen, Dänemark

Fähigkeiten und Kenntnisse

Quality Management
Project management
Risk Management
FDA Regulation
CAPA
FMEA
Medical device
Medical technology
21 CFR 820
Electro-Medical Engineering
Failure Mode and Effects Analysis
Product Development
ISO 13485
Test Engineering
Nuclear Engineering
Test Management
Project Manager
ISO14971
ISO62366
Post Markt Surveillance
Clinical Evaluation Report
Regulatory Compliance

Werdegang

Berufserfahrung von Brendan Reinicke

  • Bis heute

    Project Management

    Brendan Reinicke

    • Performed Gap analysis of all functions for an FDA readiness program. • Included were Gaps to FDA compliance for; processes, procedures and documentation. • Evaluated, safety assessed and risk ranked gaps. • Devised improvements to the risk management procedures • Formulated a “path to compliance” strategy • Provided resource and cost estimates required for gap remediation to executive leadership for decision making

  • Project Manager

    Varian Medical Systems Particle Therapy GmbH

    • Project Management of nuclear medical engineering; development projects and installation activities • Worked with design and manufacturing engineering, to develop a new feature for a proton therapy system. Worked with installation and commissioning teams to solve complex technical issues on a “first-of-a-kind” proton therapy system installation. of a complex nuclear medical system.

  • Task Force Manager

    Nokia

    Mobilized International, Large-Scale (100+ personnel), Cross-Functional, Multi-Disciplinary Teams, Solved Business Critical, Complex Dynamic Issues

  • Project Manager

    Airbus Military

    Applied Design Information for Electrical Bonding of all Wing Systems at all Build Stages

  • Test Manager - Engineer

    GN Netcom

    Headed a test engineering department. Directed all test and verification related activities. •Devised and implemented a test strategy in line with business development. •Directed test activity and achieved project targets for all products.

  • Product Engineer

    Maxtor

    Performed Failure Analysis, Design Verification and Qualification Testing, Reliability and Stress analysis. Collaborated with R&D in USA and Japan to implement and test new design proposals

  • Medical Engineering Technician

    SIEMENS

    • Installed, maintained and provided support for electromedical life-support systems, artificial respiration systems and critical patient monitoring systems, at hospital facilities nationwide • Commissioned and installed X-Ray, CT and MRI systems with specialist teams • Provided emergency support, training and advice to professional hospital staff nationwide • Performed disaster situation contingency planning and drills with major city hospitals.

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