Technical Project Manager

Talascend is currently seeking a Technical Project Manager for a contract opportunity with our client in Madison, Wisconsin.

Overview

The Technical Project Manager will lead and manage technical projects in the medical device industry, overseeing project planning, scheduling, resource management, and cross-functional collaboration to ensure successful product development and regulatory compliance.

Responsibilities

• Lead and manage multiple sustaining engineering and fixture development projects, encompassing hardware and software, from initiation through closure.
• Conduct risk assessments and develop mitigation plans to maintain schedule and costs.
• Create and maintain detailed project plans, timelines, budgets, and resource allocations.
• Facilitate regular project meetings, track progress, and manage risks and issues.
• Report project status, issues, and progress at review meetings.
• Ensure projects meet regulatory, quality, and business requirements.
• Coordinate with various cross-functional teams and external vendors.
• Manage engineering change orders, product updates, and obsolescence strategies.
• Support root cause analysis and corrective actions (CAPA).
• Oversee design, validation, and implementation of manufacturing fixtures and tooling, ensuring standards are met.
• Support process validation and documentation activities.

Qualifications

• Bachelor's degree in engineering, biomedical engineering, computer science, mechanical engineering, or related field.
• 3+ years of project management experience in the medical device industry.
• Experience with sustaining engineering and manufacturing support is a plus.
• 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.