JOB DETAILS

Senior Systems Engineer – East Coast US Further Information

Job Details

Location

East Coast US

Region

Position

Salary

100,000 - 130,000 $

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Senior Systems Engineer – East Coast US

Cartwright James is currently working with a Multinational IVD Company who is a market leader in their space. This company is looking for a Senior Systems Engineer to aid with the development of an exciting product pipeline and extensive existing portfolio.

My client is seeking a driven and dynamic individual with a proven track record in the development of IVD devices in an FDA/ISO Regulated environment.  The Senior Systems Engineer will be a key contributor to development projects, independently evaluating and applying standard engineering techniques, focusing specifically on Software and Electrical components of Diagnostic Devices.

Responsibilities:

  • Leading Projects throughout research, design, development and manufacturing, overseeing engineers and technicians in business critical assignments.
  • Providing technical support for Operations and Service departments and CAPA investigations as Systems Engineering SME.
  • Effectively performing trade off analysis.
  • Leading FMECA, FTA, traceability activities and requirements elicitations/review across R&D projects.
  • Adhering to c::11 Systems Engineering and Design Control processes.
  • Participating in and challenging designs, tolerance studies, change requests, procedures, test methods, protocols whilst assisting in the resolution of conflicting design requirements.
  • Leading the identification of product defects and outliers in results.
  • Authoring project sub-plans, requirements, risk management, protocols, reports and architecture deliverables.

Requirements:

  • MSc educated in Engineering, Science or related field.
  • IVD Medical Device industry experience highly desirable.
  • Proven knowledge of ISO14971, ISO13485 and FDA Design control requirements.
  • Competent throughout Six Sigma, DOE, Failure Analysis, FMEA, Minitab, Lab View, MathCAD, MathLAB and IBM DOORS.
  • Proven knowledge of Systems Engineering theories and practices.

Cartwright James is a global executive search and selection company based in the UK, providing expert knowledge and bespoke services in the international Chemicals, Medical and Scientific markets. We receive a vast volume of applications for each position, therefore it takes time to assess each candidate. We will be in touch if the candidates experience matches the job requirements.

 

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