About Consure Medical:

Consure Medical is a fast-growing, innovation-driven medical device company that is fundamentally changing critical care. We have built a portfolio of first-of-its-kind products in incontinence management, skin health, infection prevention, and critical care — technologies that deliver superior clinical outcomes, dramatically reduce healthcare costs, and expand patient access worldwide.

Our solutions are sold globally, protected by robust intellectual property, backed by rigorous regulatory clearances, comprehensive clinical evidence, and the highest quality standards. As we rapidly scale manufacturing — expanding cleanroom capacity, headcount, shifts, production volume, and implementing automation across quality and supply chain — we are creating once-in-a-decade opportunities to build world-class, category-defining manufacturing operations.

The Opportunity:

This is a high-impact Engineering Manager role for a hands-on technical leader ready to own the validation, scale-up, and manufacturing excellence of groundbreaking medical devices from pilot to full global commercial production.

If you’re a mechanical or electronics engineer with 5–8+ years of experience who has been honing your craft in large organizations or established manufacturers but now craves real ownership and outsized impact… or if you’re ambitious and ready to move beyond supporting roles into true leadership on the factory floor — this is your moment. You will work shoulder-to-shoulder with visionary R&D teams and production talent in a flat, high-ownership culture.

You will lead the charge on process validation, automation implementation, cleanroom expansion, and global supply chain optimization — turning first-of-its-kind innovations into reliable, high-volume products that reach patients worldwide while building and mentoring a high-performing engineering team.

Key Responsibilities:

• Lead end-to-end manufacturing engineering and validation strategy to support rapid scale-up of Class I and II medical devices, including cleanroom expansion, automation rollout, and increased production capacity.
• Own the complete validation lifecycle (IQ, OQ, PQ, PPQ) for equipment, processes, utilities, and systems — ensuring consistent, compliant, and high-quality output at scale.
• Design and optimize manufacturing processes, including mechanical fixture design, pneumatic tools, and advanced polymer processing (injection molding, extrusion, lamination, solvent bonding, ultrasonic welding, etc.).
• Drive Design Transfer, maintain Device Master Records (DMR), and integrate robust quality systems, production statistics, risk management, and compliance throughout the product lifecycle.
• Implement Lean Six Sigma methodologies, Gauge R&R, statistical process control, and continuous improvement initiatives to boost efficiency, reduce costs, and maintain compliance with FDA 21 CFR 820, ISO 13485, and global standards.
• Build, lead, and mentor a high-performing engineering and validation team while staying deeply hands-on on the production floor.
• Manage complex vendor and contract manufacturing relationships across India, China, Europe, and the USA — including vendor qualifications, audits, performance optimization, and strategic partnerships.
• Collaborate cross-functionally with R&D, Quality, Regulatory, and Operations teams to deliver validated, scalable manufacturing solutions that accelerate global commercialization.
• Provide strong technical leadership during internal audits, regulatory inspections, and customer reviews, demonstrating presence and problem-solving excellence under pressure.
• Anticipate and navigate evolving challenges — supply chain disruptions, regulatory changes, tariffs, and AI/automation advancements — turning them into competitive advantages for the company.

Requirements (We Hire for Expertise, Hands-On Ability & Leadership Mindset):

• Bachelor’s or Master’s degree in Mechanical Engineering, Electronics Engineering, or a closely related discipline.
• 5–8+ years of progressive experience in medical device manufacturing engineering and validation, with proven success scaling innovative products from pilot to commercial volumes (Class II experience strongly preferred).
• Deep, hands-on expertise in IQ/OQ/PQ/PPQ, process validation, Gauge R&R, statistical tools, Lean Six Sigma methodologies, DMR maintenance, and medical device quality systems.
• Strong technical proficiency in mechanical fixture design, pneumatic systems, polymer processing technologies, cleanroom operations, and manufacturing safety standards.
• Demonstrated experience managing vendors and contract manufacturers across India, China, Europe, and the USA.
• Exceptional intellectual and emotional intelligence — proven ability to lead and collaborate effectively with diverse teams (production floor employees, contract manufacturers, vendors, consultants) across cultures, languages, and backgrounds.
• A tactical, results-driven, entrepreneurial mindset: you thrive in fast-paced, non-hierarchical environments, believe in your ideas, execute with excellence, and build high-performing teams.

Why You’ll Love Working Here:

• Once-in-a-Decade Impact: Help build the manufacturing backbone for first-of-its-kind products that are already transforming global critical care.
• True Ownership & Scale: Move from supporting roles to owning validation, scale-up, and world-class operations on a global platform — the kind of experience that defines careers and earns industry recognition.
• Hands-On Leadership: Stay technical and on the floor while building and leading teams in a flat, entrepreneurial culture.
• Global Stage: Work with international vendors, regulators, and markets while driving real clinical and commercial success.
• Purpose + Rapid Growth: Join a mission-driven company where your work directly improves patient lives and accelerates your professional trajectory.

Location & Work Schedule:

253, Okhla Phase 3, New Delhi-110020

Mon to Sat – 9:00 AM to 6:00 PM. (Second & Fourth Saturdays and Sundays are off.)

If you are a driven, hands-on engineering leader with the technical depth, leadership presence, and ambition to scale world-class medical device manufacturing, we want to hear from you.

Apply now by sending your resume to [email protected] and help us redefine what’s possible in critical care manufacturing.