Join our team as a Software Quality Assurance Engineer and play a vital role in ensuring the quality and integrity of groundbreaking medical device software. This position offers a unique opportunity to work with a dynamic team and contribute to the development of life-changing technologies.

Responsibilities

• Collaborate with development teams to create project deliverables and conduct thorough audits before product release.
• Ensure compliance with design history and regulatory standards by addressing gaps with cross-functional teams.
• Provide assurance services for software design, including validation planning and test system development.
• Support risk management activities from the product concept phase through to commercialization.
• Offer expertise on global standards for medical device software and security to ensure compliance.
• Assist in quality engineering for design changes and ongoing engineering projects.
• Lead internal and external audit activities and contribute to other quality initiatives as needed.

Skills

• Bachelor’s degree in a technical or scientific field.
• At least 5 years of experience in medical device software quality or design assurance roles.
• Comprehensive understanding of medical software device design standards and global regulations.
• Proficiency with risk management tools and standards such as ISO14971 and IEC 62304.
• Strong project and time management skills with the capability to manage multiple tasks.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Experience with Class III active implantable products.

Preferred Skills

• Experience in software design reliability and product quality assurance functions.
• ASQ certifications such as CSQE, CRE, CQM, or CQE.
• Familiarity with bug tracking tools like JIRA.
• Experience with GHTF requirements for process validations.

At Horizontal, we are committed to fostering a diverse and inclusive workplace where all individuals are valued and empowered. We encourage candidates from all backgrounds to apply and join our mission to innovate with integrity.

Horizontal facilitates valuable and productive conversations between you and potential employers.  We can assist you in growing your career by partnering you with employers that offer challenging assignments.  For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The salary range for this role is $150,000 - $170,000. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location.