HudsonAlpha Institute for Biotechnology
  • 19-Nov-2018 to 19-Dec-2019 (CST)
  • Huntsville, AL, USA
  • Full Time
  • GeneCapture

GeneCapture

Job Title: Medical Device Systems Engineer

Job Description:

The systems engineer is responsible for all aspects of requirements management and risk management.  The systems engineer will work with the development staff to capture and maintain system level and detailed level requirements and specifications.  The systems engineer will own and drive the risk management process including planning, DFMEAs, hazards analysis, V&V plans, protocols, reports.  The candidate will drive efforts with both internal development groups and external certification agencies to facilitate safety and agency approvals.

Essential Responsibilities:

This position requires knowledge of system engineering principles.  Must be familiar with complete product life cycle for development.  Candidate must be capable of producing specifications, defining and designing interfaces to complex systems, test requirements, and performing acceptance testing (lab and field).  Provide support for engineering studies and contributing to white papers.  Identify, interpret, and process user requirements, with a focus on complex system component interoperability.  Develop system component operations concepts; requirements specifications; system architecture / design and documentation; validation and verification.  Develop detail from high-level concepts. Perform technical, schedule and interface change impact assessment for cost, schedule, performance, operation concept and procedural update.  Applicant should be self-motivated and able to handle multiple tasks concurrently

Qualifications:

To perform this job successfully, an individual must possess strong analytical and engineering capabilities, and must be able to communicate effectively both verbally and in written form.  The individual must possess a solid understanding of the medical device industry; it's value chain and structure.

Junior Systems Engineer:  Bachelor's degree in an engineering or related field (I.e., physics, CS, math).  0-5 years of experience.

Senior Systems Engineer:  Masters in engineering or science, or equivalent experience.  5-10 years experience required, including familiarity with electrical, software, mechanical disciplines, preferably in the medical device OEM field.

Competencies required:

  • Capable to drive system level design, architecture, & requirements.
  • Ability to interact with users to design the workflow and understand the end use environments.
  • Own / develop product architecture, understand design and manufacturing constraints, infuse new technology ideas where appropriate.
  • Drive integration and V&V activities.
  • Familiarity with ISO13485, IEC60601, and IEC61010 is required.
  • Experience with fluidics, disposables, and "lab on a chip" solutions is desirable.
HudsonAlpha Institute for Biotechnology
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