Sr. Manufacturing Engineer

Senior Manufacturing EngineerSupira 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.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.Responsibilities, Skills & Hands-On ExperienceCapital Equipment Management & Electronics Development: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.Vendor Management: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.Process Validation: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.Compliance and Documentation: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.Continuous Improvement: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.Education & Work Experience: Bachelor's degree in Electrical Engineering, Electronics Engineering, Mechanical/Mechatronics Engineering or a related field. Master's degree preferred. 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. Experience with pressure sensors is a plus. 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, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $125,000 - $145,000 + 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 View email address on click.appcast.io.