Project Manager - Product Development bei HistoSonics

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location: Plymouth, MN (Onsite)

Position Summary:

The Project Manager provides leadership and direction to the projects and initiatives within HistoSonics’ Project Portfolio.  The key responsibilities of the Project Manager involve management of product development projects and other organizational projects and initiatives while closely adhering to HistoSonics’ quality system and design controls.  The Project Manager may also play a role in supporting HistoSonics’ clinical trial certification efforts for an expansion into Urology.

Key Responsibilities:

• Planning and organization to support team execution for projects in the HistoSonics R&D Project Portfolio. 
• Responsible for coordination and completion of project documentation and deliverables per HistoSonics procedures.
• Responsible for coordination of project interdependencies across sub-systems, including managing resources (people and hardware) to meeting project timelines.
• Works in close collaboration with engineering leadership to ensure requirement definition and design implementation are aligned with project timelines.
• Works in close collaboration with engineering leadership and other project managers to ensure awareness and alignment across priorities and resources within the company.
• Develops a project plan at the start of each project using appropriate planning and project management tools and within the company’s quality system guidelines; conducts routine project and design reviews and publishes meeting minutes. 
• Responsible for clear and consistent communication to support project team members as well as senior leadership visibility for project status.
• Performs applicable responsibilities in compliance with the company’s Quality Management System.
• Maintains a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating with team members in an open, balanced, and objective manner.
• Creates and maintains a clean, safe, and effective work environment.  

• Maintains knowledge of current and emerging trends in the industry.
• Manages third party vendors to ensure that the vendor's deliverables are meeting HistoSonics’ product and timeline requirements.
• Determines what resources are necessary to execute projects on the desired timelines.

Position Qualifications and Skills:

• A bachelor’s degree (BS, BA) in mechanical, electrical, software or biomedical engineering, or equivalent preferred
• 8+ years of product development work experience in a medical device / healthcare environment
• Experience with Project Management and System Engineering.
• Demonstrated successful history in the full development process of medical devices in a regulated environment.

• Proven industry experience with demonstrated leadership skills and ability to engage, motivate a team and possess the ability to adapt to a continuously evolving business environment.
• Excellent written and verbal communication skills; comfortable with participating in high-level technological discussions; ability to discuss complex technology in clear, discernible terms with less technically knowledgeable parties as well as presentation skills are required along with top level interpersonal and facilitation skills.
• Demonstrated ability to develop and maintain relationships, internally and externally.
• Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills. Highly motivated, efficient, and enterprising with an inherent ability to drive tasks and projects to full completion. 
• Demonstrated record of converting strategic plans to prioritized product, development, and/or operational objectives.
• Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals.
• Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 10% of the time.

 Preferred:

• Risk mitigation experience
• Feasibility or clinical studies experience
• Startup or small company experience

Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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