About the Company
Our Medical Device client is searching for a Sr Principal PD Project Management Specialist to join our Product Development team working on new catheter designs. Cardiac Ablation Solutions is developing next generation medical technologies that treat patients with abnormal heart rhythms. This client’s technologies save lives and improves the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to perform procedures with superior outcomes.
About the Role
As a Project Management Specialist, you will be responsible for coordinating and supporting a range of new product development activities on large, moderately complex projects. You will work independently to implement strategic goals and establish operational plans, and coordinate with Project Management, R&D, Quality, Operations, Regulatory, and other functions to deliver products to our customers.
Responsibilities
* Develops and executes project plans, including schedules, budgets, and resources.
* Ensures adherence to design control requirements.
* Defines and negotiates project resource requirements.
* Communicates project status and updates to stakeholders.
* Manages project budgets and oversees capital expenditures.
* Monitors the project from initiation through delivery.
* Develops risk mitigation plans.
* Develops mechanisms for monitoring project progress.
* Travels up to 25% of the time.
Qualifications
* Requires a Level 8 Degree and minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.
Required Skills
* Experience with ablation products and therapies (e.g., catheters, generators).
* Strong understanding of medical device regulations (e.g., IEC 60601, IEC 62304, ISO 14971, ISO 13485).
* Experience with Microsoft Project and ProChain scheduling methodologies.
* Skilled in organizing work for unstructured problems or execution tasks.
* Broad engineering knowledge across product development functions.
* Ability to effectively interface and communicate with employees at all organizational levels.
* Strength in working with cross-functional teams across facilities to solve problems.
* Ability to work independently and take the initiative on tasks.
* Exceptional influencing and interpersonal skills, negotiating, managing change, resolving conflict.
* Master’s degree in Engineering and/or scientific discipline, or MBA.
* PMP certification.
* Lean/Six Sigma certification.
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