PathnSitu Biotechnologies
Website:
pathnsitu.com
Job details:
A rapidly growing, mid-sized Biotechnology and Medical Technology company based in the innovation hub of Hyderabad, India. We specialize in developing cutting-edge, software-driven medical devices and biotech solutions. As we scale our operations, we are seeking a visionary, hands-on Head of Engineering to lead our R&D, design, and manufacturing divisions.
POSITION OVERVIEW The Head of Engineering will take complete ownership of the engineering lifecycle, driving products from initial design and prototyping through to final manufacturing. This leadership role requires a rare blend of deep technical expertise across electronics, mechanical domains, and software-integrated systems, alongside robust project governance and team leadership capabilities.
KEY RESPONSIBILITIES:-
1. End-to-End R&D & Product Lifecycle Management
· Full-Lifecycle Execution: Lead the engineering R&D team from conceptual designing and rapid prototyping to final manufacturing setup.
· Multi-Domain Integration: Bridge the gap between mechanical design, electronics (hardware), and embedded software systems.
· Software-Driven Devices: Guide, troubleshoot, and mentor the team on developing, testing, and optimizing software-based biotech/medtech devices.
· Innovation & Collaboration: Foster a highly collaborative environment that drives product innovation, cost efficiency, and design for manufacturability/testing (DFM/DFT).
2. Project Governance & Technical Execution
· Governance Reviews: Provide critical technical inputs, risk assessments, and strategic direction during project governance reviews.
· Baseline Performance: Monitor and report on technical scope performance against baseline plans, project timelines, and stated business benefits.
· Estimates & Execution Plans: Identify key technical deliverables based on agreed project scope; use these to build accurate project estimates and execution plans.
· Technical Quality & Compliance: Ensure all engineered products and processes are technically fit for purpose and rigidly comply with medical device statutory requirements and regulatory standards (e.g., CDSCO, ISO 13485, CE/FDA where applicable).
· Scope & Change Control: Act as the technical gatekeeper, ensuring all technical scope changes are evaluated and formally agreed upon with the Project Manager prior to implementation.
· Resource Optimization: Partner with the project planner to define technical team resource needs, map milestones, monitor progress, and support cost controllers with precise engineering estimates.
· Project Closure: Oversee the technical closing of project processes, ensuring proper documentation, transfer to manufacturing, and post-launch reviews.
3. Team Leadership & Operations Management
· Daily & Monthly Schedules: Establish clear operational schedules, tracking and analyzing team productivity to optimize output.
· Smart Delegation: Assess individual strengths to delegate tasks effectively, maximizing engineering efficiency.
· Mentorship & Motivation: Actively mentor, motivate, and cultivate high performance among cross-functional engineering teams.
· Safety & Adherence: Champion a culture of safety, ensuring strict adherence to laboratory, workshop, and manufacturing safety guidelines.
· Documentation: Prepare technical proposals, progress reports, patents, and alignment documentation for the Board of Directors and key stakeholders.
REQUIRED PROFILE & QUALIFICATIONS
· Industry Experience: Minimum 12–15+ years of core engineering experience, with at least 5 years in a leadership role within the Medical Technology (MedTech), Medical Device, or Biotech equipment manufacturing industry.
· Education: B.E. / B.Tech / M.Tech in Electronics Engineering, Mechanical Engineering, Biomedical Engineering, or a related discipline.
· Domain Expertise: Proven hands-on exposure to both electronics (PCBA design, firmware, IoT) and mechanical domains (enclosures, tooling, kinematics).
· Software Familiarity: Strong understanding of software development architectures for connected devices, GUI systems, or cloud-integrated medical hardware.
· Regulatory Knowledge: Deep understanding of medical device quality management systems, safety guidelines, and compliance frameworks.
· Executive Presence: Ability to confidently articulate technical risks, project statuses, and engineering roadmaps directly to Board-level stakeholders.
· Location: Based in or willing to relocate to Hyderabad, India.
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