Technical Architect

Job Summary

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.

Key Responsibilities

• 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.

Skill Requirements

• 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