Senior Electrical Manufacturing Engineer

We are seeking a Senior Electrical Manufacturing Engineer to lead the industrialization and manufacturing readiness of a generator for our clients next-generation cardiovascular device from design verification through submission and commercial launch. This hands-on role partners closely with R&D while leading manufacturing process development, validation, and design transfer with both internal teams and contract manufacturers.

Responsibilities

• Develop and optimize manufacturing processes supporting prototype, verification, validation, clinical, and commercial production.
• Partner with R&D to incorporate Design for Manufacturability (DFM), Assembly (DFA), Testability (DFT), and Serviceability (DFS).
• Lead Design Transfer, manufacturing readiness, process validation (IQ/OQ/PQ), and production ramp.
• Develop manufacturing documentation including work instructions, mBOMs, routings, DMRs, PFMEAs, Control Plans, and process flow documentation.
• Develop and validate manufacturing test methods including ICT, AOI, functional testing, firmware loading, calibration, electrical safety testing, and final system testing.
• Serve as the primary Manufacturing Engineering liaison with system integration and PCBA contract manufacturers, supporting supplier qualification, engineering builds, process validation, and commercialization.
• Drive manufacturing quality and continuous improvement through DOE, statistical analysis, Lean Manufacturing, Six Sigma, root cause investigations, CAPAs, and process optimization.
• Collaborate cross-functionally with Engineering, Quality, Regulatory, Operations, Supply Chain, and Program Management to support commercialization milestones.

Qualifications

• BS/MS in Electrical, Manufacturing, Mechanical, Biomedical Engineering, or related field.
• 7+ years of manufacturing engineering experience in regulated medical devices.
• Experience commercializing complex capital equipment with high-voltage electronics, embedded software, and PCBAs.
• Experience supporting Class III medical devices through Design Verification, Design Transfer, and commercial launch.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1, IQ/OQ/PQ, PFMEA, DOE, SPC, and Design Controls.
• Experience working with contract manufacturers and supplier qualification.
• Ability to interpret electrical schematics, PCB assembly, and mechanical drawings.
• Startup or fast-paced commercialization experience preferred.