Senior Software Quality Engineer
Posted on 11/10/2022
Remote • United States
- Support development of engineering / product concepts that are innovative, high-quality, cost-appropriate, and satisfy all stakeholder's (customer, manufacturing, material, agency, etc.) needs and requirements through an established area of technical specialty and mentorship of others on the global discipline team
- Support evaluation of software development lifecycle activities including requirements, design, development, documentation, integration, test, verification and validation for the applicable software safety classification
- Manage or support risk management activities including risk management planning and Risk Analysis ownership activities such as software FTA and DFMEA
- Ensure adherence to defined laws, regulations, standards, guidelines, and specifications primarily in the healthcare and life sciences industry (IEC 60601-1, IEC 62304, 21 CFR 820, ISO 13485, ISO 14971, etc.)
- Author and review product documentation for adherence to Plexus Quality Management System and regulatory submissions
- Assist project management in the development of proposals to ensure accurate technical, staffing, budgetary, and schedule content
- Demonstrate desire and skill in coaching and mentoring other quality team members on the Software development lifecycle framework
- Drive continuous improvement of Plexus QMS processes through CAPA and other improvement initiatives
- Support the Lean culture and effectively utilizes Lean Sigma concepts and tools to identify and eliminate waste while improving processes
- A Bachelor's degree in Engineering is required
- Five (5) years of relevant experience with the topics below is required
- Compliance in regulated software environments, specifically healthcare
- Full Software life cycle product development with a focus on pre-production
- Quality documentation for regulatory submissions
- Experience with Cybersecurity, such as threat modeling, data flow diagrams, certification, NIST framework, and post market surveillance
- Willingness to travel to support customer and team development needs
- Experience working with Safety Agencies (such as Nationally Recognized Testing Laboratories (NRTL))
- Experience performing Non-Product Software Validation
- A workplace centered on collaboration and integrity
- Supportive leadership teams that value work life balance through a flexible work environment
- An inclusive environment which values diverse backgrounds, experiences and expertise
- Flexible career paths across a variety of disciplines
- Innovative design solutions and state-of-the-art technology that improves lives
End-to-end product realization solutions
In order to provide seamless product realization, Plexus has been partnering with companies around the world to transform their concepts into branded products and deliver them to the market with customer service like you’ve never seen in the electronics manufacturing industry.
- Professional and personal development
- Plexus Global Mentor Program
- Accessible Resources
Company Core Values
- We are dedicated to our internal and external Customers and tenaciously strive to help them succeed.
- We value building relationships and working collaboratively.
- With drive and energy, we commit ourselves to successful outcomes and to be exceptional in everything we do.
- We communicate our opinions and ideas openly and transparently, value when others freely do so and engage in constructive debate.
- We maintain high ethical standards.