Software Quality Design Engineer - 90k - Middlesex County, MA

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Job description

This company is seeking a Software Quality Design Engineer to oversee quality engineering tasks for pharmaceutical manufacturing, including risk management, documentation, and CAPA management. The ideal candidate will have 2-5 years of experience in medical device software quality, expertise in risk management (ISO 14971, FMEA), and a background in Agile methodologies. This is a fully onsite position in Middlesex County, MA.

Client Details

This company in Middlesex County, MA is dedicated to pioneering advancements in pharmaceutical manufacturing and healthcare technology. Their commitment to innovation and quality is reflected in their work, and they are seeking a highly skilled Software Quality Design Engineer to join their team in Middlesex County, MA. This role is fully onsite and integral to their mission of enhancing patient outcomes through high-quality software solutions.

Description

As a Software Quality Design Engineer, you will oversee and ensure the successful delivery of quality engineering tasks from initial product concept through to commercialization. This includes leading risk management activities such as Risk Management Framework (RMF), Failure Mode and Effects Analysis (FMEA), and Cybersecurity Risk Assessments. You will also be responsible for developing and executing Quality Plans, and guiding the creation and documentation of standard operating procedures, specifications, and test procedures.

Key Responsibilities:

• Leadership and Execution: Lead and manage the completion of Quality Engineering deliverables, ensuring timely and accurate execution of risk management activities, including RMF, FMEA, and Cybersecurity Risk Assessments.
• Quality Planning: Support the on-time implementation of Quality Plans throughout the product lifecycle.
• Documentation and Development: Guide the development and documentation of standard operating procedures, specifications, and test procedures to meet regulatory and company standards.
• CAPA Management: Oversee Corrective and Preventive Actions (CAPA) by conducting thorough investigations, root-cause analyses (e.g., Fishbone, 5 Whys), implementing corrective actions, and monitoring effectiveness.
• Product Recertification: Assist with product recertifications to ensure compliance and continued quality.
• Agile Framework: Work within the Agile software development lifecycle, supporting Agile practices and automated testing methodologies.
• Usability Reviews: Contribute to usability and human factors engineering reviews to enhance product design and user experience.
• Coaching and Mentoring: Mentor and coach team members on best practices in design quality, product lifecycle testing, and quality engineering with an emphasis on Agile and automated testing practices.
• Review and Approvals: Participate in system and software requirement reviews, software and firmware design evaluations, code inspections, and review and approve test methods, protocols, and results.

Profile

Key Skills and Qualifications for the Software Quality Design Engineer:

• Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent combination of education and experience.
• 2-5+ years of experience in software quality design within the medical device industry; experience in cybersecurity design quality is a plus.
• Proven experience with software for medical devices is required.
• Expertise in Risk Management, including ISO 14971, and FMEA is essential.
• Familiarity with Agile development practices and experience with CAPA management.
• Strong analytical skills, with the ability to conduct detailed root-cause analysis and implement corrective actions effectively.

Job Offer

• Competitive salary and comprehensive benefits package.
• Opportunities for career growth and professional development.
• A collaborative and innovative work environment.
• A fully onsite role with a focus on impactful work that improves patient care.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

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