Principal Project Manager

Principal Project Manager

We are seeking a candidate with exceptional organization and leadership skills to drive the conceptualization, development, and delivery of new innovative ablation systems. The Project Manager role includes working on new development programs bringing new products to market and working with the project management team on best practices, tools and refinement for lean execution resulting in the highest quality programs.

• Responsible for active leadership of the project and project team.
• Collaborate and coordinate resources from R&D, Operations, Quality, Regulatory, Marketing, Usability, Medical Affairs, and others as project needs arise.
• Assist the team by planning and coordinating all activities, anticipate and mitigate obstacles, and monitor/report performance. The project manager performs these duties with a mindset of acceleration and they aggressively resolve threats to project duration and spend.
• Ensure all team members are aligned to the project goals. Serves as a subject matter expert for the Design Control Process and the project itself.
• Monitors the project from initiation through delivery including planning and directing schedules. Organizes cross-functional activities, ensuring completion of the project i.e. product on schedule and within budget constraints.
• Help coordinate resources between project managers and programs. You will help clarify design control process, tools and create templates and processes.
• Integrate new ideas into the programs for continuous improvement on execution. You will work the team to ensure lessons learned and processes that worked well are taken advantage of.
• Lead multiple cross functional projects within Microwave Ablation R&D (currently focused on the Intelliblade product family).
• Guide projects through QMS phase reviews and ensure all design control deliverables are met.
• Manage scheduling, risks, status reporting, and stakeholder communication.
• Collaborate with UX, Quality, Regulatory, Manufacturing, Clinical, Product Management, and Risk teams.
• Workload split: ~80% project management, ~20% technical or other contributions.

What you will have:

• Bachelors degree in related field (Engineering degree preferred), and 8 years of related experience or 6 years and a Masters degree.
• Direct project management experience running programs on medical devices with capital equipment and disposables.
• Knowledge of medical device regulations and design control requirements for electromechanical systems containing electronics, mechanical assemblies, software and graphical displays.
• Proficiency in project management & collaboration tools such as MS Project and equivalent ERP product and productivity software desired.
• Experience in managing R&D projects from initial concept into full production.
• Experience with programs including capital equipment such as floor standing consoles with touch screen displays for user input.
• Experience with programs including single use disposables.

1. Direct project management experience in medical device development (highly preferred). 2. Strong understanding of medical device regulations & design control requirements. 3. Excellent communication & cross functional leadership skills.

• Microsoft Project (primary tool for planning/tracking)
• Familiarity with ERP systems (e.g., SAP), but no specific ERP tool required; general understanding is sufficient.

• Bachelor’s degree required (no flexibility stated).
• Engineering background (biomedical, electrical, mechanical, systems) is highly desirable.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.