- 785 Challenger St, Brea, CA 92821, USA
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 role you will manage required builds for existing product development improvements/new product development in a pilot or in a production setting.
- Manage required builds for existing product development improvements/new product development in a pilot or in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, and troubleshooting assembly issues.
- Provide manufacturing capacity analysis of existing product lines.
- Lead the development of highly capable manufacturing processes for new existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
- Develop and coordinate the execution of process characterization and validation plans.
- Comply with applicable FDA and international regulatory laws/standards.
- Lead/support production line in non-conformance investigations and dispositions.
- Development of manufacturing documentation (MP, Traveler, BOM).
- Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
- Design and implement custom equipment/tools, fixtures and/or off the shelf equipment/tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
- Work with outside OEM Suppliers, internal/external machine shops and or other departments/groups.
- Application of statistical and analytical methods such as SPC, SQC, and DOE.
- Participation on project teams tasked with new process/product development and the successful transfer into manufacturing.
- Process background (development, capability, optimization, validation) within a regulated industry.
- Other duties as assigned or required.
- AutoCAD, Solid works, 3matic.
- Knowledge in materials associated with medical devices.
- knowledge in processes associated with medical manufacturing.
- Proficient in design and process FMECA/FMEA/Hazards Analysis/Risk Analysis, Process Validation, and variability reduction applications.
- Proficiency with program languages such as (g-code, CO++, VB etc.) but not required.
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.
- Able to lift up to 25 lbs.