Sr. Quality Engineer, Supira Medical

Supira Medical, Inc.; Los Gatos (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Quality Engineer to join their innovative team in Los Gatos, CA. This role offers the opportunity to drive quality and compliance in the development of cutting-edge medical devices, including a unique percutaneous ventricular assist device. You will actively engage in test method validation, design controls, and risk management, ensuring adherence to quality management systems. This full-time position promises a collaborative environment where your expertise will significantly influence product development and patient outcomes. Join a forward-thinking company dedicated to advancing healthcare technology and making a real difference.

Benefits

Medical Insurance

Vision Insurance

401(k)

Disability Insurance

Qualifications

• Experience in quality engineering role, preferably in medical devices.
• Proficient in test method validation and design controls.

Responsibilities

• Drive test method and process validations, including IQ/OQ/PQ.
• Collaborate with cross-functional teams to ensure quality compliance.

Skills

Test Method Validation

Process Validation

Design Controls

Risk Management

Communication Skills

Education

B.S. or higher in Biomedical Engineering

5+ years in Quality Engineering

Tools

Statistical Techniques

Data Analysis

Job description

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This range is provided by Supira Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$90,000.00/yr - $180,000.00/yr

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

Our Senior Quality Engineer will proactively drive quality and compliance in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages.

As a key member of the team, you will actively support test method and process validation, design controls, design history file, risk management, design verification and process validation protocols and testing. This position also provides technical support to Operations and R&D groups. This position will also play an active role in the development and maintenance of the quality management system and ensure QMS compliance adherence. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• Drive both test method and process validations, including IQ/OQ/PQ for new and existing processes and test methods. Maintain the Master Validation Plan/Report.
• Collaborate closely with cross-functional teams, including Operations/Manufacturing, and R&D.
• Provide technical guidance and mentorship to junior engineers to cultivate a collaborative work environment.
• Support design controls deliverables, including but not limited to DHF, design verification documentation and risk management documentation.
• Support development and maintain risk management file and associated deliverables, such as PFMEA and hazard analysis.
• Excellent communication skills: ability to work both independently and in project team setting.

Education & Work Experience

• B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience.
• 5+ years of experience in a quality engineering role. Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred.
• Experience with Design Controls and Risk Management for medical device and/or interventional cardiology products.
• Proficiency and/or exposure to test method validation, process validation, and Design Verification including statistical techniques and data analysis.
• Working and demonstrated knowledge about medical device regulations, including FDA QSR, 13485, EU MDR etc.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [e-mail].

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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