Manufacturing Engineer, Supira Medical

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

As a Manufacturing Engineer at Supira, you will play a critical role in ensuring the successful process development and validation, and vendor management for our medical devices. Your expertise will directly impact the quality, safety, and regulatory compliance of our products, ultimately improving patient care worldwide. Reporting to the Engineering Manager, you will collaborate with cross-functional teams to drive innovation, uphold industry standards, and foster a culture of excellence. 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

• Process Validation:

• Lead the process validation activities, ensuring compliance with relevant regulations and standards (e.g., FDA, ISO13485).

• Develop and execute validation protocols, including IQ/OQ/PQ for new and existing processes.

• Participate in risk management activities, including development and ownership of process FMEAs.

• Analyze and interpret validation data, identify trends, and implement corrective actions as needed.

• Collaborate with the Quality Assurance team to ensure processes meet strict quality and regulatory requirements.

• Maintain and improve functional inspection processes.

• Process Development:

• Drive process development efforts, adhering to the product requirements and design control procedures.

• Conduct feasibility studies, risk assessments, and verification/validation activities for electronic components and systems.

• Collaborate with the R&D team to integrate process and design changes seamlessly into the overall manufacturing process flow.

• Stay updated on emerging technologies and industry trends to propose innovative solutions for future processes.

• Vendor Management:

• Establish and maintain strong relationships with external vendors and contract manufacturers.

• Assess potential vendors for electronics components and production capabilities.

• Negotiate contracts, monitor performance, and ensure adherence to agreed-upon specifications and timelines.

• Resolve any vendor-related issues promptly and proactively identify opportunities for improvement.

• Compliance and Documentation:

• Ensure all engineering activities comply with regulatory requirements and company policies.

• Generate and maintain comprehensive documentation related to process validation, electronics development, and vendor interactions.

• Prepare and participate in audits and inspections as required.

• Continuous Improvement:

• Participate in solving the day to day manufacturing issues that arise.

• Drive continuous improvement initiatives through data analysis, Lean manufacturing principles, and Six Sigma methodologies.

• Identify areas for process optimization, cost reduction, and efficiency improvement.

• Initiate and lead continuous improvement projects to enhance product performance and manufacturing processes.

• Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.

• Mentor and train junior engineers, interns, sharing knowledge and best practices.

Education & Work Experience

• Bachelor's degree in biomedical engineering, Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, or related field.

• Proven experience (2+ years) in process validation, development, and vendor management within the medical device industry.

• Experienced using LabVIEW for data capture and data analysis.

• In-depth knowledge of relevant regulations and standards (e.g., FDA, ISO, IEC).

• Familiarity with various validation methodologies (IQ/OQ/PQ), statistical analysis, and validation documentation.

• Exceptional project management and problem-solving skills.

• Excellent communication and interpersonal abilities to collaborate effectively across teams and with external partners.

• Ability to thrive in a fast-paced, dynamic environment and prioritize tasks effectively.

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 hr@shifamed.com.