Device Manufacturing Lead

  • 785 Challenger St, Brea, CA 92821, USA
  • Full-time

Company Description

Company Description

On December 31st, 2020 Innova Medical, Inc. acquired MPS Medical to expand its U.S production of COVID-19 antigen test kits, producing over 4 million SARS-CoV-2 Antigen Rapid Qualitative Tests per day.  Currently, Innova Medical Group, Inc. is the world’s largest manufacturer of rapid antigen test kits and leader in COVID-19 testing solutions arena.

Innova Medical Group, Inc. achieves to deliver better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Alongside of COVID-19 solutions, Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious disease.

In this position the Device Manufacturing Lead is responsible for a variety of tasks including planning, scheduling, and helping resolve production issues.

www.innovamedgroup.com

Job Description

  • As a member of the manufacturing team, participates in assigned production activities.
  • Executes pre-determined work assignments in support of manufacturing objectives.
  • Follows all applicable manufacturing documentation in the assembly and testing of product.
  • Prior to executing work steps, ensures that all appropriate training has been received and documented.
  • Ensures that all tasks are executed in accordance with Company Quality System
  • requirements.
  • Ability to perform in process inspections and special testing on medical device products.

Qualifications

  • Requires a high school diploma, technical courses, or equivalent industry experience.
  • 3-5 years manufacturing experience in IVD manufacturing in medical devices industry Preferred.
  • Experience in clean room environment, delicate machine assembly under medical device assembly (GMP).
  •  Automation machine, packaging, and other manufacturing experience a plus.
  • Good communication skills, both written and oral.
  • Knowledge of and experience in manufacturing medical devices in conformance with Quality System Regulation and ISO requirements

Additional Information

PHYSICAL DEMANDS –Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:

• Physically able to sit, stand and walk for extended periods of time.

  • Must be able to lift up to 25 lbs.