09 Aug
|
Digital Health Solutions
|
Thane
09 Aug
Digital Health Solutions
Thane
Company Overview
Digital Health Solutions (DHS) is a premier consulting firm dedicated to helping medical device companies navigate complex regulatory, engineering, and product development challenges. We specialize in guiding clients through IEC 62304 and ISO 13485 compliance, supporting them in delivering innovative, secure, and effective medical technologies to market.
Position Overview
We are seeking a Principal Mechanical Engineer with 10+ years of experience in product design, development, prototyping, testing, and manufacturing. This is a hands-on technical leadership role responsible for early- to late-stage device development, from initial concept and feasibility through design transfer, manufacturing, and commercialization. The Principal Mechanical Engineer will lead mechanical design activities across a diverse range of medical technologies, including Class II and III devices such as handheld therapeutic devices, surgical consoles and handpieces, wearable and implantable device accessories, and diagnostic instrumentation.
Projects at DHS routinely integrate mechanical,
electrical, firmware, and software systems, offering broad exposure to the full product lifecycle. You will architect enclosures, mechanisms, and consumables; drive design for manufacturability; and ensure designs meet the safety and regulatory requirements that govern medical devices, including IEC 60601 electrical safety, ingress protection, and biocompatibility considerations.
The ideal candidate combines deep technical expertise, regulatory fluency, and leadership presence, thrives on variety, is comfortable owning designs from whiteboard sketch to injection-molded production part, and can mentor junior engineers while engaging directly with clients, vendors, and cross-functional teams.
Key Responsibilities
Lead mechanical design activities for medical devices from concept through verification, validation, and commercialization, adhering to regulatory requirements and quality standards
📌 Principal Mechanical Engineer (Thane)
🏢 Digital Health Solutions
📍 Thane