Minimum 2-3 years of experience in quality engineering within medical device R&D
Strong background in product software validation and quality oversight
Experience with risk assessment and mitigation techniques
Familiarity with US FDA regulations and international standards (e.g., IEC 62034, ISO 14971)
Previous role as a Software Quality Engineer or Validation Engineer.
Responsibilities
Lead meetings to prioritize and approve action plans for problem resolution
Conduct risk evaluation and management activities for product software development
Participate in technical reviews to ensure compliance with design plans
Provide quality oversight for non-product software validation
Support cybersecurity assessments as part of a cross-functional team
Ensure compliance with regulatory requirements and company policies
Collaborate effectively with cross-functional team members, especially software suppliers.
Benefits
Collaborative work environment fostering partnerships across teams
Opportunity to work at the forefront of medical device innovation
Engagement with cross-functional teams in addressing complex challenges
Potential for skill enhancement through involvement in diverse quality oversight activities
Contributions to critical projects that impact patient health outcomes.
Full Job Description
Summary:
Provides technical and quality system guidance related to establishing product software as a medical device requirements.
Provide quality oversight for product software as a medical device verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, reviewing and approving software test case protocols and reports, review of software development plans, and review of other system and software documentation.
Product software as a medical device - verification and validation activities for new products (Quality Engineer supporting the R&D team).
Roles and Responsibilities:
Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
Leads risk evaluation and associated management activities related to product software development including Risk assessments (e.g. FMEA), product risk analysis, and mitigation of software issues.
Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design controls.
May provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
Maintains a strong, collaborative partnership with cross functional team members especially with software supplier.
Works as an individual contributor and may provide guidance of other QE team members.
Education & Experience:
Medical device - R&D product software .
resource shall have a background in the medical/pharma domain.
resource shall have product software validation experience and a minimum of 2 to 3 years of experience in Quality.
Resource shall have experience as a Software Quality Engineer or Validation Engineer and Quality Engineer.
