Work to design, develop, validate and document the manufacturing processes at Contract Manufacturer's site in order to build PCBAs efficiently and in compliance with medical devices standards. Responsible for providing 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. Demonstrates 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 PCB assembly line processes and operations. Leverage DOE (Design of Experiments) and Design for Manufacturing and assembly (DFMA). 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 for Navigating the requirements of Good Manufacturing Practices (GMP) and Good Documentation practices (GDP) and Manufacturing tools like Minitab to predict efficiency and deficiencies that were overlooked during the process. **Eligible for telecommuting from home within reasonable commuting distance from Northridge, CA. Will require physical presence at worksite in Northridge, CA 3 to 4 days a week. Salary Range: $120,000.00 - $130,000.00/year. Job Requirements: Requires a Master's degree in Electrical, manufacturing or biomedical engineering, or a directly related engineering field and two (2) years experience in medical devices. Must possess at least two (2) years' experience with each of the following: • Development and optimization of products, processes, tooling and equipment • FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971 • IPC Standards including IPC-6012, IPC-A-600, J-STD-001 and IPC-A-610 • PCB assembly line processes and operations. • DOE (Design of Experiments) and Design for Manufacturing and assembly (DFMA) • Development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV) • Six sigma, NCMR (Non-conforming Material Report) and CAPA (Corrective and Preventative Action) • Document control and manufacturing tool software including as Windchill, Agile, Trackwise, SAP and Minitab. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation MiniMed offers a competitive salary and flexible benefits package. Salary range for U.S. (excl. PR) locations (USD): $120,000.00 to $130,000.00 Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico. #LI-DNI