Technical Project Manager
Talascend
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.
- 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.
Background Check and Drug Screen may be required.
$84.63k - $112.84k
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