Lead Medical Device Systems Engineer

Planet Pharma; Hazelwood (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Planet Pharma in Hazelwood, Missouri is seeking a Lead Systems Engineer to provide technical leadership for the development of complex medical device systems and disposables, coordinating across software, hardware, design control, and external partners.

You will own system requirements, architecture, risk analysis, verification planning, and ensure milestones. Requires a Bachelor's degree and 10 years' related experience plus FDA familiarity.

Qualifications

• Bachelor degree in engineering or scientific discipline.
• 10 years of professional experience in complex hardware/software/biology systems with FDA experience.
• Experience with FDA regulatory requirements.

Responsibilities

• Lead system development across hardware, software, integration, and design control.
• Coordinate system development with microbiology and chemistry functions and external partners.
• Own System Product Requirements and System Architecture.
• Lead or coordinate complex technical activities and risk analysis.
• Communicate project status and ensure readiness for milestones.
• Ensure compliance with company quality procedures and standards.

Skills

System leadership

Cross-functional coordination

Design control

Education

Bachelor degree in engineering or science

MS preferred (Systems/Biomedical)

Job description

Planet Pharma in Hazelwood, Missouri is seeking a Lead Systems Engineer to provide technical leadership for the development of complex medical device systems and disposables, coordinating across software, hardware, design control, and external partners.

You will own system requirements, architecture, risk analysis, verification planning, and ensure milestones. Requires a Bachelor's degree and 10 years' related experience plus FDA familiarity.