Principal Software Quality Engineer, Redwood City, CA (Onsite role)

About the Role

Key Responsibilities

• Follow procedures to guide software and systems development and ensure compliance with relevant regulatory requirements.
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams, including: Software Design Control Documentation, Software-related Product specification and Device Master Record, Systems and/or sub-systems software design verification & validation activities, Cybersecurity Assessment, Risk Management, CAPA / NCMR, External Standards and Regulatory Audits, Quality Investigations (CAPA, SW Anomalies), Traceability.
• Participate in cybersecurity, post market vulnerability assessments, HHEs and other risk management processes.
• Support internal and external regulatory audits, regulatory submissions, and other quality assurance functions.
• Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.
• Demonstrate understanding of software best practices and promote implementation into the quality system.
• Work with departments to discuss system gaps, fixes, design solutions and risks.
• Project leader on various projects by representing Quality Assurance.
• Provide concise updates of critical projects to Senior Management.
• Perform other duties as required.

Requirements

• 8+ years of Quality /Regulatory experience in a medical device or other regulated industry.
• Bachelor's degree in a technical or science major.
• 8 years' experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
• Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc.
• Experience working with Cloud based infrastructure and systems that process, store, and distribute large sets of data continuously.
• Experience with Medical Device Firmware/Software Development.
• FDA Software guidance of Verification & Validation.
• Strong understanding and working knowledge of IEC 62304, EN ISO 14971, FDA Software Guidance or similar standards.
• Understanding and working familiarity with AAMI TIR 57, AAMI TIR 97, IEC 81001-5-1, IEC 30111.
• Project management skills; capable to lead project teams.
• Highly developed written and oral communication skills and strong collaborator able to guide and influence partnered engineering teams.
• Must have good problem-solving skills and be able to work independently.
• Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation.
• Must be organized, detail-oriented and adaptable according to evolving situations at hand.
• ASQ Certified Software Quality Engineer (CSQE) and/or Six Sigma Green/Black belt preferred.

Nice to Have

• Master's Degree in a technical or science field.
• ASQ Certified Software Quality Engineer (CSQE) and/or Six Sigma Green/Black belt.

Qualifications

• Bachelor's degree in a technical or science major.
• 8+ years of experience in a regulated industry.

Benefits & Perks

• Market-leading medical, dental, and vision benefits.
• 401k matching.
• Ample vacation time.
• Pre-tax savings perks.
• Tuition reimbursement.
• Employee Stock Purchase Plan (ESPP).
• Short and/or long-term incentive opportunities.
• Recognition awards.
• Volunteer time off.
• Employee resource groups supporting Wellness, Leadership Development, and Diversity and Inclusion.