Senior Quality Engineer (Electrical & Software Engineering)

EBR Systems • Sunnyvale, CA

71d • $126,700 - $163,000

About The Position

The Senior Quality Engineer will incorporate cross-functional project teams and contribute to product specification development and quality planning activities. Responsibilities include authoring and managing documentation for design verification and validation, software and process validations, human factors, and risk analysis. Lead the analysis of complaint and ensure compliance with quality management systems and regulatory requirements. Supporting production by troubleshooting issues and improving yields, collaborating with contract manufacturers to resolve issues, closing non-conforming material reports promptly, and ensuring adherence to internal procedures are crucial.

Requirements

• BS in electrical, software Engineering, or equivalent biomedical Engineering with software engineering experience.
• Minimum seven (7) years of experience is preferred, with related medical device experience.
• Understanding of regulatory requirements for the medical device industry, specifically, IEC 60601, IEC 62304, 21 CFR 820, ISO 13485, ISO 14971, and HIPPA.

Nice To Haves

• Proficiency with PC-based office computers, including familiarity with Microsoft Office suite required.
• Proficiency with statistical software, such as MiniTab, preferred.
• Strong foundation in education, skills in electrical and software engineering.
• Expert in tools and processes for root cause analysis.
• Ability to work independently, using good judgment, initiative and analytical abilities.
• Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
• Self-motivated and self-directed; conscientious approach to work assignments.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.

Responsibilities

• Act as the Subject Matter Expert for QA for Design Control SOPs, DHF, Standards Compliance, and Design Transfer records.
• Support regulatory audits of Product Development function and outputs.
• Review, approve, and provide guidance for Design Verification and Validation activities, product and software traceability matrix.
• Responsible for quality engineering review of Document Change Orders for Product Development and Software update.
• Perform firmware/software verification, regression, and integration testing: including testing software fixes, cybersecurity update and logging/tracking software defects.
• Experience with Printed Circuit Boards (PCB), electronics laboratory equipment, validation of system with rechargeable battery.
• Create and design appropriate test methods, protocols and accurately generate complex written reports which include establishing statistical confidence by identifying sample size and acceptable error rates.
• Lead CAPA generation, performing thorough root cause investigation and documenting corrective and preventative action plans.
• Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations.

Benefits

• Medical, dental, and vision insurance provided at no cost for employee-only coverage.
• 401(k) matching plan.
• Paid Time Off - starting at 3 weeks per year.
• Competitive salary with opportunities for career growth.
• Employee stock options.
• Life & AD&D and long term disability insurance.
• Education assistance.
• Voluntary commuter benefits and pet insurance.
• Weekly company lunches and occasional happy hour events.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees