Electrical Product Engineering (Medical Device)

Job Title: Electrical Product Engineering (Medical Device)

Location: Irvine CA (Onsite)

Experience: 6 8 Years

We are seeking a skilled and motivated Electrical Engineer to support Continuous Improvement Projects (CIP) within a dynamic medical device environment. This role involves working closely with cross-functional teams and external suppliers to drive cost optimization product enhancements and design improvements while ensuring compliance with regulatory and quality standards.

Key Responsibilities:

Lead and execute Continuous Improvement Projects (CIP) in collaboration with internal stakeholders and external suppliers

Perform cost analysis and CIP calculations including evaluation of supplier quotations

Develop and manage project budgets considering feasibility capital equipment validation costs and testing requirements (e.g. DVT bioburden where applicable)

Create and maintain detailed project plans using Microsoft Project and prepare presentations using PowerPoint

Apply strong knowledge of electrical design product architecture and system functionality

Drive design changes component substitutions and supplier transitions to achieve cost savings and performance improvements

Develop innovative strategies to meet cost reduction and performance goals

Conduct engineering testing create test protocols generate reports and lead design reviews

Oversee project timelines dependencies and execution strategies to ensure successful delivery

Identify appropriate electrical test methods and align requirements with R&D teams

Support process validation activities and complete required documentation (RR forms validation reports etc.)

Manage and execute change requests and supplier change control processes

Ensure adherence to health safety environmental and regulatory standards

Communicate project updates risks and opportunities to management

Provide technical guidance to junior engineers or technicians when required

Perform additional duties as assigned

Required Skills & Qualifications

6 8 years of experience in Electrical/Product Engineering preferably in the medical device industry

Strong experience in Continuous Improvement (CIP) and cost optimization initiatives

Solid understanding of electrical design system architecture and product lifecycle

Hands-on experience with testing validation (DVT) and documentation

Knowledge of medical device regulations and quality standards (e.g. FDA ISO)

Experience working with suppliers sourcing and cost evaluation

Proficiency in Microsoft Project and PowerPoint

Strong analytical problem-solving and communication skills

Preferred / Nice-to-Have Skills

Experience supporting Splash Team Projects

Familiarity with bioburden testing and advanced validation processes

Prior experience in supplier transition and change management