Product Development and Engineering Manager

The Product Development and Quality Engineering Manager will:

Lead Agile software development and documentation initiatives with internal and external engineering teams, aligned with IEC 62304 and SaMD requirements.

Manage sustaining engineering projects and production planning with contract manufacturers, focusing on product and production improvements, cost reductions, and supply continuity.

Maintain integrated schedules, risks, and cross-functional alignment across engineering and production teams and commercial demands.

Facilitate sprint planning, technical reviews, and cross-functional coordination to drive on-time execution.

Track and report on project status, risks, and key milestones to senior leadership.

Collaborate with the Quality & Compliance Manager to maintain and improve the QMS in accordance with FDA 21 CFR Part 820, ISO 13485, and EU MDR.

Lead requirements management to ensure all system, software, and hardware specifications are complete, testable, and aligned across disciplines.

Drive risk management activities in accordance with ISO 14971, including updates to risk files and mitigation tracking.

Develop and maintain V&V protocols and reports for software updates, manufacturing changes, and product improvements, including compliance with IEC 60601 and IEC 62304.

Own traceability between design inputs, risk controls, and verification/validation (V&V) activities.

Maintain design documentation such as DHF, DMR, and engineering change orders (ECOs), ensuring quality system alignment.

Lead design reviews, design change control boards, and risk reviews to ensure disciplined design control processes.