Program Manager

Position Overview:

Lead cross-functional engineering, quality, manufacturing, and supply chain teams to deliver electromechanical medical device components from development through production launch and ramp-up. Own integrated schedules (e.g., Gantt/MS Project), design-control milestones, and program reporting to ensure on-time, compliant execution aligned to customer requirements and the company Quality Management System.

Essential Job Functions:

Lead cross-functional teams to execute product development and manufacturing programs; run program reviews and stakeholder communications. Build and maintain integrated program plans, schedules, milestones, and deliverables (MS Project/Gantt or equivalent); track status, risks, dependencies, and actions.

Coordinate design-control activities and documentation:

design inputs/outputs, design reviews, verification & validation, risk management, and design transfer. Own DHF coordination and readiness for internal/customer reviews and audits; ensure development records are complete, organized, and traceable. Maintain a program risk register; drive mitigation of technical, quality, manufacturing, and schedule risks, including DFMEA/PFMEA-derived risks. Plan and lead design transfer into controlled manufacturing: process validation (IQ/OQ/PQ), tooling/equipment readiness, manufacturing documentation, training, and production release readiness reviews. Monitor early production ramp (yield, defects, validation completion) and coordinate issue resolution with engineering, manufacturing, and quality. Ensure program execution aligns to the Quality Management System; support NC investigations, CAPA, and internal/external audits as needed. Serve as primary internal program contact for customers; coordinate technical/program communications, meetings, and readiness discussions.

Required Qualifications:

Education:

Bachelor's degree in Engineering (Mechanical, Electrical, or related) or equivalent experience.

Experience:

5+ years managing complex engineering/manufacturing programs in a regulated environment (medical device preferred); proven cross-functional leadership.

Technical:

Product development, design controls, design transfer, and manufacturing process knowledge; ability to interpret drawings/specifications.

Preferred:

Electromechanical assemblies/motors/electronics/precision components;

ISO 13485

familiarity; PMP or similar training/certification.

Core competencies:

Program planning, clear communication, risk-based decision making, strong documentation discipline, and ability to manage multiple priorities.