Senior Quality Engineer

COMPANY OVERVIEW

We are Med Acuity, Inc. We partner with leading product development companies to develop life and mission-critical software bringing the highest levels of Service and Value to every engagement. Through our consulting and development engagements, we bring the best and brightest talent to our clients, applying deep technical knowledge, business acumen, and innovative solutions to complex engineering problems and constructing aligned solutions for our clients.

Our approach forges long-term, collaborative relationships with clients enabling them to focus on their own core competencies in Medical Devices, Robotics, and Aerospace / Defense Equipment.

JOB SUMMARY

We seek a passionate and seasoned Senior Software Quality Engineer who is interested in playing a key role in the cutting edge Med Tech space. The Senior Quality Engineer enjoys working closely and cross-functionally throughout the full life cycle of projects with both internal and external constituents, including clients. The successful candidate is experienced in executing quality strategies throughout the software development lifecycle in collaboration with Software Development, Product Management, UX / UI Design, Dev Ops, and Regulatory / Quality teams.

They will be responsible for ensuring the quality, reliability, performance, and regulatory compliance of regulated medical device software.

Together, we’re pioneering the future of science by developing software products and solutions that enable our partner teams to help save lives.

• Develop and execute test plans, test cases, and test scripts.
• Contribute to software verification plans, perform data and performance analysis, and writing of final reports, including test summary reports and defect justifications.
• Generate defect reports and verify correct technical fixes while also investigating / isolating root cause of defects and leading triage meetings.
• Develop and implement quality metrics associated with software development and testing performance.
• Assess and evaluate new tools and testing methodologies in addition to leading tool validation efforts.
• Analyze architecture and designs to identify test strategies to provide full test coverage.
• Participate in analysis and refinement of requirements for testability, gaps, and clarity.
• Identify risk management activities to ensure software risk control measures are identified and verified; assist with risk-related documentation, if necessary.
• Abide by and ensure compliance with Med Acuity’s policies, including Information Security and Quality Management Systems.

• 8+ years of experience with relevant and recent expertise performing the same or similar type of work as required by the position in compliance with the recognized standards below:
  • Strong working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO
    14971.
• Experience supporting medical device development and production release cycles.
• Professional background working in Agile / Scrum development environments.
• Expertise with defect tracking and metrics.
• Hands‑on experience with requirements management software such as Helix ALM, Jama or Doors.
• Strong technical writing skills, including development of test methods, protocols, reports.
• Proficient computer skills with applicable software packages such as Microsoft Office, Matlab, Excel, etc.

• Possess a complete understanding of software development lifecycle phases.
• Strong analytical and troubleshooting skills.
• Excellent written and verbal communication.
• Risk-based decision making.
• Quality mindset with attention to detail.
• Ability to influence cross-functional teams.

• Bachelor’s Degree in Computer Science or a related discipline OR equivalent years of experience in a comparable role.

A realistic estimate of starting base salary for this this full-time position is $120,000 to $135,000. The actual salary offered may vary based on work location, experience, education, training, external market data, internal pay equity and other business considerations. This position qualifies for a discretionary performance based bonus based on personal and company factors. We also…