Assembler

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:

This is a temporary position. You will be responsible for the manufacturing and preparation of assemblies for operations and R&D medical devices. May develop into more complex manufacturing processes such as bonding and electrical soldering and assembly processes. Part of a small manufacturing and R&D team with daily interactions with engineers and technicians. 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:

• Apply adhesives to small components using needles, EFD dispensers, and syringes.
• Utilizes various techniques for bonding different materials with heat, lamination, UV cure processes.
• Perform manufacturing processes and inspections under a microscope.
• Solders small parts and wires to printed circuit boards and completes re-work.
• Follow Manufacturing Process Instructions (MPIs) to build and inspect medical devices. Fill out design history files (DHR) as required.
• Work on several different batches at different manufacturing processes throughout the day.
• Communicate and document issues and observations with supervisor and engineers.
• Comply with production control requirements including those related to environmental controls, CER requirements, hygiene, documentation, and procedural compliance.
• Support the Quality System and Quality Policy. Be aware of Quality System procedures, requirements, and training requirements. Inform responsible personnel of concerns involving product quality.
• Ability to read and interpret bill of materials (BOM) and accurately pick materials required for scheduled work orders.
• Reviews work orders and ensure appropriate level of materials, tools, equipment, and resources are available for production functions.
• Completes in-process-inspection to ensure product meets work instruction specifications, quality attributes and reports variances immediately to lead/supervisor.
• Responsible for assigned production efficiency, productivity and accuracy of items produced to minimize backlog. Meets or exceeds standard rates.
• Maintains the cleanliness, organization, quality control and safety of work area.
• Follows safe working practices and wears required personal protective equipment.
• Mechanical aptitude and skills using hand tools, small power tools and soldering iron.
• Ability to read and interpret schematics, prints and engineering documentation.
• Skill in performing basic mathematical calculations.
• Ability to distinguish colors for color coding practices.
• Ability to perform detailed repetitive tasks for prolonged periods of time.
• Attentive to detail with good planning time management skills, and willing to assume a variety of production/assembly related tasks.
• Skills in effectively listening and communicating tactfully verbally and in writing.
• Ability to establish and maintain effective working relationships internally and externally.
• Fine dexterity for assembling small components and good attention to detail.
• Good understanding of GMP, Clean room procedures and behavior.
• Ability to use tools and measurement devices. Ability to use automated equipment.
• Good communication skills to describe issues or observations as they are observed.
• Must be able to document activities clearly. Basic computer and writing skills. Must be a team player.

Education & Work Experience:

• High School Diploma or General Education Development (GED) certificate.
• Experience in a manufacturing/assembly work-related environment required.
• HS diploma (AA degree preferred) or equivalent experience in technical discipline and a minimum of 5 years (3 with AA) in medical device manufacturing.
• Experience with 5S manufacturing.
• Experience with medical device manufacturing including following good manufacturing practice (GDP).

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 pay rate for this temporary position is between $27-$32 per hour.

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 [email protected].