What are the responsibilities and job description for the Akura Medical position at Shifamed?
Akura Medical, a Shifamed Portfolio Company, is focused on the development of a novel interventional thrombectomy system to address Venous thromboembolism (VTE). Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths.
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.
Summary/Responsibilities:
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.
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.
Summary/Responsibilities:
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.
- Assemble components into medical devices in accordance with approved manufacturing procedures.
- Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
- Perform in-process quality checks on sub-assemblies and finished product.
- 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 and/or Job 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.
Given that many of the essential functions of this role must be provided on site or in person, this role requires full COVID-19 vaccination (subject to any exemptions or accommodations due to medical or religious reasons).
Salary : $42,300 - $53,500
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