Senior Quality Engineer (Electrical & Software Engineering)

EBR Systems•Sunnyvale, CA

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.
Can be an equivalent combination of education and professional experience.
Proficiency with PC-based office computers, including familiarity with Microsoft Office suite required.
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, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
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; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently.
Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
Travel required up to 10% of the time, including weekend and overnight travel.
Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.
Required to stoop, kneel, bend, crouch and lift up to 20 pounds.
Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Nice To Haves

Proficiency with statistical software, such as MiniTab, preferred.

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. This includes testing for process validations, test method validation and data analysis.
Lead CAPA generation, performing thorough root cause investigation and documenting corrective and preventative action plans. Ensure action plans are implemented in a timely manner.
Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost.
Proactively solve moderately complex problems at the product level.
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.
Adhere to established company Quality System procedures, the Quality Policy, and work instructions.
Maintain state of the art technical knowledge.
Partner with the Regulatory Affairs staff to ensure technical accuracy for domestic and international regulatory filings.
Other duties as assigned.

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
Meaningful work and much more!