Sr. Manufacturing Engineer

Shifamed•Los Gatos, CA

About The Position

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. As a Senior Manufacturing Engineer at Supira, you will play a critical role in ensuring the successful capital equipment and electronics manufacturing, development, vendor management, and process validation 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 Sr. Engineering Manager, you will collaborate with cross-functional teams to drive innovation, uphold industry standards, and foster a culture of excellence.

Requirements

Bachelor's degree in Electrical Engineering, Electronics Engineering, Mechanical/Mechatronics Engineering or a related field.
5+ years of experience in process validation, electronics 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).
Strong expertise in electronics design, PCB layout, and circuit analysis.
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.

Nice To Haves

Master's degree preferred.
Experience with pressure sensors is a plus.

Responsibilities

Collaborate cross functionally on electronics design and 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 electronics seamlessly into the overall manufacturing process flow.
Design and development of manufacturing processes.
Stay updated on emerging technologies and industry trends to propose innovative solutions for future processes
Establish and maintain strong relationships with external vendors and contract manufacturers.
Assess and qualify vendors for 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.
Lead the process validation activities, ensuring compliance with relevant regulations and standards (e.g., FDA, ISO13485).
Optimize processes via designing and executing DOEs
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.
Identify and implement process monitoring controls
Maintain and improve functional inspection processes.
Ensure all engineering activities comply with regulatory requirements and company policies.
Generate and maintain comprehensive documentation related to process development and validation, electronics development, and vendor interactions.
Prepare and participate in audits and inspections as required.
Identify areas for process optimization, cost reduction, and efficiency improvement.
Initiate and lead continuous improvement projects to enhance product performance and manufacturing processes.
Design and qualify equipment / fixtures to streamline and improve manufacturing processes
Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.
Perform root cause investigations, material dispositions and implement corrective and preventive actions
Mentor and train junior engineers, sharing knowledge and best practices.