Engineer

Meridian Bioscience, Inc North Billerica , MA 01862

Posted 3 months ago

Job Summary

Electrical/Software Verification and Validation (V&V) Engineer will be responsible for verifying and validating the hardware and software of medical diagnostics devices. Under minimal supervision, the V&V engineer will participate in the development activities including hardware and software requirements, architecture, design, implementation, integration and testing. The selected candidate will work within an interdisciplinary team of engineers and scientists. They will also interface with external development vendors for embedded & firmware software development, application software development and specification development.

Key Duties

  • Verification planning, assembly, test preparation, and maintenance of engineering prototype medical systems

  • Ability to develop and execute V&V test plans, protocols, reports and test procedures

  • Review and evaluate product requirements for correctness, completeness and testability

  • Performs integration testing to ensure software functions within application and with electrical and mechanical devices

  • Troubleshoots and implements fixes to assigned hardware and software defects

  • Submit Engineering Change Requests to create or revise validation documentation, test methods, and fixture drawings

  • Create and support the relevant documentation in a regulated (FDA) environment as required

  • Review the DHF for completeness, accuracy and compliance throughout the device's lifecycle

  • Participate as an active member on a project development team; This includes requirements change control, defect management, risk analysis, and release management

  • Must have the ability to take ownership for high complexity implementations.

  • Provide technical updates to project leadership for all ongoing work assignments

  • Strictly adhere to company defined processes and procedures standard

  • Perform other related duties as assigned

Qualifications

Education/Experience:

  • Bachelor's in Electrical or Software Engineering or related field required. Master's Degree preferred

  • At least 5 years professional working experience in engineering

  • Experience in developing medical devices in an FDA-regulated environment is a plus

Skills, Specialized Knowledge and Abilities:

  • Ability to work on complex development tasks including new development, new features to existing instrument, and maintenance

  • Must have strong interpersonal and problem-solving skills with ability to interact effectively with all levels of the organization both internally and externally.

  • Ability to prioritize multiple tasks from various stakeholders

  • Capacity to work from detailed specifications or from defect reports

  • Ability to clearly communicate ideas and solutions to other team members

  • Can work independently with minimal supervision

  • Must possess strong organizational skills with attention to detail to prioritize and balance workloads while meeting strict critical deadlines and performing under pressure in a fast-paced environment.

Requirements (Physical, Mental, Environmental Demands):

  • Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility

  • Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.)

  • Must be able to adhere to applicable bio-safety practices when on the manufacturing floor

  • Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day

  • Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the work day

  • Must be able to analyze, concentrate and solve complex issues routinely through the course of the work shift and remain focused in a fast paced open environment throughout the course of the work day

  • Must be able to travel by car/air to other MBI locations as needed.

We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.


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Engineer

Meridian Bioscience, Inc