R+D System

1 week ago

Cincinnati OH United States Midmark Corporation Full time
Description

JOB SUMMARY:

Collaborates within a team to ensure the delivery of high-quality software and system solutions. Fosters an environment of continual improvement through the review of established quality assurance and design verification processes and practices, recommending areas for improvement and efficiency. Develops and validates test methods and protocols based on defined requirements for manual and automated testing, contributing to improvements in the quality assurance or verification framework. Performs work under minimal supervision. May mentor more junior teammates.  This role is expected to be on-site in the Cincinnati or Versailles, Ohio location 4 days a week.  This is not a remote position.

ESSENTIAL/PRIMARY DUTIES:

  • Designs, reviews, and executes verification protocols for medical devices, software, and firmware at the system or platform level using various test methodologies for manual and automated testing.
  • Creates use case or scenario-driven test scripts for automated testing.
  • Analyzes test data and generates reports for software, firmware, and system or platform level testing at an expert level.
  • Collaborates with cross-functional teams to create, review, and improve verification plans and traceability matrices.
  • Establishes and assists junior engineers in the setup of test environments and tools, including computers, IT infrastructure, test fixtures, data acquisition tools, etc.
  • Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting efforts for manual and automated testing.
  • Acts as a team contributor with some technical leadership, providing guidance, anticipating, and identifying risks, and recommending mitigation options.

SECONDARY DUTIES:

  • Influences Midmark processes for Design Controls of Medical Devices or the Software Development Lifecycle (SDLC) for software products as applicable.
  • Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies.
  • Influences change within and across disciplines.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both.

COMPETENCY and/or SKILL: 

  • Solid knowledge of the requirements gathering process to drive deeper understanding and distillation of the requirements and specifications to derive effective test scenarios
  • Solid working knowledge of engineering change order (ECO) and product delivery processes and procedures
  • Advanced capability to troubleshoot, reproduce, communicate, and document system and software issues
  • Strong understanding of product standards and regulations common in medical devices/life sciences such as ISO, IEC, FDA, and HIPAA relative to the verification process
  • Comprehensive knowledge of Test Management Tools, Product Lifecycle Management and Delivery tools, etc.
  • Solid working knowledge of statistical analysis tools and software, such as Minitab, R, Python, etc.

SUPERVISORY RESPONSIBILITIES:

  • Provides leadership, coaching, and/or mentoring to junior engineers focusing on technical skills, collaboration skills, and cultural competencies.

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