> Markdown version of [/jobs/ext/4319895-technical-architect](https://www.wearedevelopers.com/jobs/ext/4319895-technical-architect). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Technical Architect - **Company:** HCL America, Inc. - **Location:** United States - **Experience:** Expert - **Salary:** $87,000.0 - $172,000.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Systems Engineering, EHealth, Firmware, Meditech - **Published:** October 27, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=c8d12d2900bfa06e ## About the Role * Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. * 8+ years of experience in Program Management, Technical Program Management, or Product Development leadership roles. * 5+ years of experience within Medical Devices, Diagnostics, Digital Health, or other regulated healthcare industries. * Proven experience leading complex New Product Development programs from concept through commercialization. * Strong understanding of Design Controls, Risk Management, Verification & Validation, and Design Transfer processes. * Experience working within FDA-regulated and ISO 13485 environments. * Demonstrated ability to manage aggressive schedules, competing priorities, and cross-functional stakeholders. * Excellent communication, leadership, facilitation, and problem-solving skills Must Have Skill Design Verification & Validation,Program & Project Management,Vendor Management,Project risk management,Systems Engineering,New Product Development, * PMP certification or equivalent Program Management certification. * Experience with Class II or Class III medical devices. * Experience managing hardware-software integrated systems. * Familiarity with Agile and traditional product development methodologies. * Experience supporting global development teams and external partners. * Drives accountability and execution across cross-functional teams. * Effectively manages ambiguity and rapidly changing priorities. * Anticipates risks and develops proactive mitigation strategies. * Communicates clearly with technical teams, leadership, and external stakeholders. * Delivers programs on schedule while maintaining product quality and regulatory compliance. ## Description Customer is seeking an experienced Technical Project/Program Manager (TPM) to lead cross-functional New Product Development (NPD) programs within a fast-paced MedTech environment. The TPM will be responsible for driving complex product development initiatives from concept through commercialization, ensuring delivery against aggressive timelines, quality requirements, regulatory expectations and business objectives., * Lead end-to-end execution of medical device NPD programs, ensuring alignment with business objectives, scope, budget, quality, and schedule commitments. * Develop and maintain integrated program plans, milestone tracking, resource plans, and dependency management across multiple functions. * Coordinate cross-functional teams including Systems Engineering, Hardware, Software, Firmware, Mechanical Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Product Management. * Drive program governance, status reviews, executive communications, and decision-making processes. * Identify, assess, and proactively mitigate technical, regulatory, operational, and schedule risks. * Facilitate design reviews and ensure compliance with Design Control processes throughout the product lifecycle. * Partner with Quality and Regulatory teams to support compliance with FDA, ISO 13485, ISO 14971, IEC 62304, and other applicable standards. * Monitor critical path activities and remove obstacles to maintain program execution and milestone achievement. * Coordinate verification, validation, design transfer, and product launch activities. * Manage external vendors, development partners, and suppliers as required. * Provide regular executive-level reporting on program health, risks, mitigation plans, and resource needs. * Drive continuous improvement of program management processes, tools, and best practices.