Sr. Manufacturing Electrical Engineer

We anticipate the application window for this opening will close on 7 Jul 2026.

Job Overview
Work to design, develop, validate and document the manufacturing processes at a Contract Manufacturer’s site in order to build PCBAs efficiently and in compliance with medical devices standards. Provide engineering guidance and project support for the design, development and optimization of products, processes, tooling and equipment. Work with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971.

Demonstrate understanding of design and manufacturing of continuous glucose monitors and insulin pumps. Adhere to various IPC Standards including IPC‑6012, IPC‑A‑600, J‑STD‑001 and IPC‑A‑610. Responsible for PCBA assembly line processes and operations. Leverage DOE (Design of Experiments) and DFMA (Design for Manufacturing and Assembly). Develop Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV).

Utilize Six Sigma methodologies for NCMR (Non‑conforming Material Report) and CAPA (Corrective and Preventative Action). Leverage document control software including Agile, Trackwise and SAP to navigate the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP). Use manufacturing tools like Minitab to predict efficiency and identify deficiencies overlooked during the process.

• Design, develop, validate, and document manufacturing processes for PCBAs
• Provide engineering guidance and project support for product, process, tooling, and equipment optimization
• Ensure compliance with FDA QSR, ISO 13485, ISO 14971, and IPC standards
• Operate and optimize PCBA assembly line processes and operations
• Apply DOE and DFMA to improve manufacturing performance
• Develop and execute IQ, OQ, PQ, Gage R&R, and TMV
• Implement Six Sigma techniques for NCMR and CAPA
• Maintain document control using Agile, Trackwise, SAP, and other manufacturing tools
• Use Minitab for statistical analysis and process improvement predictions

• Master’s degree in Electrical, Manufacturing, Biomedical Engineering, or a directly related field
• At least two (2) years of experience in medical devices
• Minimum two (2) years’ experience with:
  • Development and optimization of products, processes, tooling, and equipment
  • FDA Quality System Regulation, 21 CFR Part
    820, ISO
    13485, and ISO
    14971
  • IPC Standards (IPC‑6012, IPC‑A‑600, J‑STD‑001, IPC‑A‑610)
  • PCB assembly line processes and operations
  • DOE and DFMA
  • Development of IQ, OQ, PQ, Gage R&R, and TMV
  • Six Sigma, NCMR, and CAPA
  • Document control and manufacturing tools including Windchill, Agile, Trackwise, SAP, and Minitab
• Physical job requirements to support the manufacturing environment

Eligible for telecommuting from home within reasonable commuting distance from Northridge, CA. Will require physical presence at the worksite in Northridge, CA 3 to 4 days a week.

Salary range: $ – $ per year.

Benefits include health, dental, and vision insurance;
Health Savings Account;
Healthcare Flexible Spending Account; life insurance; long‑term disability leave; dependent daycare spending account; 401(k) with company match; short‑term disability coverage; paid time off and holidays;
Employee Stock Purchase Plan;
Employee Assistance Program;
Non‑qualified Retirement Plan Supplement;
Capital Accumulation Plan (subject to IRS criteria).

It is the policy of Mini Med to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

In addition, Mini Med will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees.