| 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 The Sr. Manufacturing Manager contributes to medical device product design, development, manufacturing, and testing in accordance with the company’s Quality System. Helps generate design outputs where required through interface with cross-functional team members. Contributes both individually and as a team leader. 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 - Recruit and manage engineers, technicians, and assemblers.
- Create development and improvement plans for manufacturing.
- Oversee process validation activity.
- Oversee facility for compliance to quality and regulatory requirements.
- Provide day-to-day manufacturing support and decision-making; troubleshoot assembly process issues as necessary; respond with urgency to process and equipment issues.
- Develop manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling, and materials.
- Perform process optimization and manufacturing scale-up; develop and implement ergonomic improvements to the process.
- Research, develop, modify, and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
- Improve manufacturing efficiency through planning and evaluation of workflow, space requirements and equipment layout.
- Calculate production, labor, and material costs; manage and adjust production schedules to meet demand.
- Prepare production forecasts; manage component and finished good inventory; schedule reorder points.
- Assure product and process quality by designing test methods, performing process validations and process capability studies.
- Establish manufacturing and inspection procedures; prepare process validation protocols and reports; execute process validations; collect and analyze process data and trends and implement changes.
- Drive and provide support to quality processes and applying formal problem-solving techniques to determine root cause, and implementing solutions (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).
- Provide training to associates, technicians and assemblers; assisting other technical associates.
- Design and validate fixtures and tools for manufacturing and inspection processes.
- Design, execute, and analyze experiments using sound statistical methodology. Participate in risk management activities, including development and ownership of process FMEAs.
- Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.
- Support company goals and objectives, policies and procedures, and regulatory requirements (FDA regulations, ISO 13485, MDD, etc.).
Education & Work Experience - Bachelor’s in Engineering, Biomedical or Mechanical or equivalent experience.
- 10+ years of previous medical device experience, preferably in the cardiovascular industry.
- Experience developing and executing process and/or equipment validations.
- Proven ability to prioritize, initiate, and drive projects to completion.
- Experience with quality system documentation requirements and test protocols.
- Experience managing production, including creating forecasts and managing inventory.
- Must be proficient in SolidWorks.
- Understanding and exposure to principles of product design, manufacturing, risk analysis, and product testing/reporting.
- Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement, and troubleshooting.
- Familiarity with FDA QSR, ISO 13485, and the MDD.
- Excellent communication skills; ability to work independently or in project team setting.
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 $170,000 - $195,000 + 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.
|
