Assembler - Delivery Systems, Tioga Cardiovascular

Tioga Cardiovascular, a Shifamed Portfolio Company, is developing a minimally invasive, transcatheter mitral valve replacement therapy that is both easier to use and implantable in a higher percentage of patients with mitral regurgitation. To learn more about Tioga Cardiovascular, please visit www.tiogacardiovascular.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

Performs a variety of mechanical prototype, sub-assemblies, final assemblies and finished device. Works from diagrams, drawings, work instructions, SOPs and in accordance with GMP regulations. Makes continuity checks on work in process and completed. Brings abnormalities to the attention of supervisors in a timely manner. May conduct quality inspections on processing line in accordance with quality specifications. 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

• Experience in catheter fabrication processes, including polymer tubing bonding, braiding, coiling, lamination, tipping, flaring, skiving, laser welding and mechanical assembly.

• Assemble components into medical devices in accordance with approved manufacturing procedures.

• Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.

• Adhere to GMP standards.

• Perform line clearance and in-process quality checks on sub-assemblies and finished product.

• Strong organizational skills, and experience managing material inventory a plus.

• Work with engineers and technicians to resolve line issues and suggest improvements.

• Maintain cleanroom integrity via proper gowning techniques and adherence to cleanroom environment practices and procedures.

• Complies with Standard Operating Procedure requirements. Meets quality standards and performs basic measurements.

• Completes documentation in an accurate and comprehensive manner Adhere to general safety rules, manufacturing procedures, company policies and procedures and FDA regulations.

• Maintains a clean and organized work area. Performs duties in a safe manner while adhering to safety policies.

• Cross-train new team members.

Education & Work Experience

• High School diploma or equivalent, preferred.

• Minimum 2-4 years of experience in medical device industry.

• Ability to utilize basic math skills.

• Ability to use pin gauges, digital calipers, snap gauges, digital micrometers and be able to determine Min Max of dimensions.

• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $58,000 to $67,000 + 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.