Manufacturing Engineer

Shifamed•Los Gatos, CA

3d•$90,000 - $115,000

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. 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 Manufacturing Engineer 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.

Requirements

Bachelor’s in Mechanical, Biomedical Engineering or equivalent experience.
0 - 3 years of previous medical device experience.
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.

Responsibilities

Work as part of a cross-functional team to develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing
Effectively document work throughout the development process inclusive of lab notebooks, design reviews, Manufacturing Process Instructions (MPIs), equipment qualifications, and process validation
Develop new manufacturing processes as needed, refine the process (through DOE and other methodologies) and implement the process into the production setting
Select and manage critical suppliers and vendors
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.
Improve manufacturing efficiency through planning and evaluation of workflow, space requirements and equipment layout.
Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
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.
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.).