Sr. Quality Engineer, Supira Medical

Shifamed LLC; Los Gatos (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

An innovative medical device company is seeking a Senior Quality Engineer to join their dynamic team. This role offers the opportunity to influence the design and development of cutting-edge medical technologies aimed at improving patient outcomes. You will lead quality and compliance initiatives, ensuring adherence to regulatory standards while collaborating closely with cross-functional teams. If you are passionate about quality engineering and want to make a significant impact in the medical field, this position is perfect for you. Join a forward-thinking organization dedicated to advancing healthcare solutions.

Qualifications

• 5+ years of experience in quality engineering in the medical device industry.
• Experience with Design Controls and Risk Management for medical devices.

Responsibilities

• Drive test method and process validations, including IQ/OQ/PQ.
• Collaborate with cross-functional teams in Operations and R&D.
• Support design controls deliverables and risk management documentation.

Skills

Test Method Validation

Process Validation

Design Controls

Risk Management

Communication Skills

Education

B.S. in Biomedical Engineering

B.S. in Electrical Engineering

B.S. in Mechanical Engineering

B.S. in Systems Engineering

Tools

Statistical Techniques

Job description

Our team shares a passion for developing innovative medical
technologies that improve patients’ lives. If you are seeking a
dynamic environment where you can make a real impact,
Shifamed is a good fit for you.

Position:Sr. Quality Engineer, Supira Medical

Location: Los Gatos, CA

Job Id:591

# of Openings:0

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].

Note: Principals only. No third party referrals will be accepted without prior approval by Shifamed. As a general practice, Shifamed does not accept unsolicited resumes or placement information from any individual or agency that supplies candidates for a fee.

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