Project Manager

Talascend is currently seeking a Project Manager with our client in Madison, Wisconsin.

Overview

The Technical Project Manager will be an engineering professional responsible for leading technical projects through planning, scheduling, budget management, and resource management for change control and stage gate projects in alignment with the departments SOPs in a matrix of cross-functional groups.

Responsibilities

• Lead and manage multiple sustaining engineering and fixture development projects, encompassing both hardware and software, from initiation through closure.
• Leads risk assessment for technical and project related issues and developing mitigation plans to ensure appropriate mitigations are in place, to ensure schedule and costs are maintained.
• Develop and maintain detailed project plans, timelines, budgets, and resource allocations.
• Tracks and manages project budgets, metrics, and resource utilization.
• Facilitate regular project meetings, track progress, and manage risks and issues.
• Report out progress, issues and status at regular review meetings.
• Ensure projects meet regulatory, quality, and business requirements.
• Manages multiple concurrent projects and ensures timely progress reporting and escalation of issues impacting deliver.
• Collaborate with Product Development, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Coordinate with external vendors and contract manufacturers as needed.
• Serve as the primary point of contact for project status and communication.
• Manage engineering change orders, product updates, and obsolescence strategies.
• Support root cause analysis and corrective/preventive actions (CAPA).
• Drive cost reduction, reliability improvements, and design optimizations.
• Oversee the design, validation, and implementation of manufacturing fixtures and tooling.
• Ensure fixtures meet any ergonomic, safety, and regulatory standards.
• Support process validation (IQ/OQ/PQ) and documentation.

Qualifications

• Bachelors degree in Engineering, Biomedical Engineering, Computer Science, Mechanical Engineering, or related field.
• 3+ years of project management experience in the medical device industry.
• Strong knowledge of FDA 21 CFR Parts 820, design controls, ISO 13485, and GMP.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).
• Excellent communication, leadership, and organizational skills.
• PMP certification or equivalent is a plus.
• Familiarity with CAD tools and fixture design principles is a plus.