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.

We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.


Background Check and Drug Screen may be required.