Planet Pharma
Principal Engineer – Drug Delivery Devices
Lead cross‑functional teams in the development of mechanical and electro‑mechanical drug delivery devices. This includes a broad range of products such as needle protection systems, fluid transfer devices, pen injectors (manual and automatic), and micro‑infuser pump systems. The Principal Engineer will drive technical execution, ensuring successful design, development, verification, validation, and regulatory submission of these devices.
Key Responsibilities
Lead cross‑functional collaboration with Marketing, Operations, and Development teams.
Define and evaluate product requirements to ensure technical completeness and subsystem integration.
Develop and manage project plans, schedules, and deliverables.
Author and review key product development documentation including architecture, design specifications, development plans, characterization protocols, and V&V plans.
Provide technical mentorship and guidance to junior engineers.
Required Skills & Experience
Minimum 10 years of experience in the medical device industry.
Proven leadership in projects from concept through FDA 510(k) and PMA approval processes.
Strong expertise in electro‑mechanical medical device design and commercialization.
Material and test specification development.
Protocol and report writing.
Process and test development.
Prototyping and design verification.
DOE/SPC optimization and validation (IQ, OQ, PQ).
FMEA and risk analysis.
Experience with drug/device combination product development.
Familiarity with regulatory standards: 21 CFR 820, EU Directive 93/42/EEC, EN 60601.
Hands‑on experience with small‑scale device assembly.
Strong analytical skills with the ability to interpret technical literature and regulatory guidelines.
Excellent problem‑solving and risk management capabilities.
Ability to manage multiple projects in a fast‑paced, deadline‑driven environment.
Benefits Medical insurance, Vision insurance, 401(k)
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Key Responsibilities
Lead cross‑functional collaboration with Marketing, Operations, and Development teams.
Define and evaluate product requirements to ensure technical completeness and subsystem integration.
Develop and manage project plans, schedules, and deliverables.
Author and review key product development documentation including architecture, design specifications, development plans, characterization protocols, and V&V plans.
Provide technical mentorship and guidance to junior engineers.
Required Skills & Experience
Minimum 10 years of experience in the medical device industry.
Proven leadership in projects from concept through FDA 510(k) and PMA approval processes.
Strong expertise in electro‑mechanical medical device design and commercialization.
Material and test specification development.
Protocol and report writing.
Process and test development.
Prototyping and design verification.
DOE/SPC optimization and validation (IQ, OQ, PQ).
FMEA and risk analysis.
Experience with drug/device combination product development.
Familiarity with regulatory standards: 21 CFR 820, EU Directive 93/42/EEC, EN 60601.
Hands‑on experience with small‑scale device assembly.
Strong analytical skills with the ability to interpret technical literature and regulatory guidelines.
Excellent problem‑solving and risk management capabilities.
Ability to manage multiple projects in a fast‑paced, deadline‑driven environment.
Benefits Medical insurance, Vision insurance, 401(k)
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