Senior Quality Engineer

As a Senior Quality Engineer, you will lead cross-functional project teams, contribute to product specification development, author documents for design verification and validation, software and process validations, human factors and risk analysis.

A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible.

Are you curious, creative, and driven? If you are passionate about healthcare innovation, EBR could be the place for you.

We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

Please note this is an on-site position. Relocation assistance is not available.

What you’ll do :

• Responsible for quality engineering review of Document Change Orders for Product Development and Software update.
• 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 and approve Design Verification and Validation activities, product, and software traceability matrix.
• Perform firmware / software verification, regression, and integration testing : including testing software fixes, cybersecurity update and logging / tracking software defects.
• Create and document 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.

• Participate in technical product complaint investigations and root cause determination.
• Participate as CAPA owner, 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.
• Work with Contract Manufacturers to ensure compliance to requirements and product quality and lead the resolution of product quality issues remediations.
• 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.

Other Duties and Responsibilities

• Partner with the Regulatory Affairs staff to ensure technical accuracy for domestic and international regulatory filings.
• Maintain a professional, credible image with key physicians, consultants, suppliers, and co-workers.
• Other duties as assigned.

Education and Experience

• BS in biomedical engineering, or equivalent.
• Minimum seven (7) years of experience is preferred, with related medical device experience.
• Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, 21 CFR 11 and EU MDR.

Knowledge, Skills, and Abilities

• Proficiency with PC-based office computers, including familiarity with Microsoft Office suite required. Proficiency with statistical software, such as MiniTab, preferred.
• 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.
• Must be available and willing to work flexible schedules, as needed.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.

Salary Range : $122,500 - $157,500

$122,500 - $157,500

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services.

Please refrain from solicitations at this time.

About EBR Systems

Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE CRT System technology, eliminating the need for pacing leads.

Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities :

• Medical, dental, and vision insurance
• 401K
• PTO starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life insurance
• Weekly company lunches and occasional happy hour events

J-18808-Ljbffr