Project Manager - (Medical Device Research & Development) - Hybrid in Minneapolis, MN

CVRx, Inc.-posted 1 day ago
Full-time • Mid Level
Hybrid • Brooklyn Park, MN
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As a Project Manager for CVRx, you will be seen as a strategic and highly collaborative leader, both in-house as well as with contracted development teams. The Project Manager (PM) will be responsible for driving complex implantable medical device projects through the full product lifecycle, from concept through commercialization. This Project Manager will ensure the disciplined execution of the development process to translate validated market needs into viable, compliant products. The PM drives cross-functional accountability, ensures team adherence to Design Control principles, and identifies process improvements to achieve on-time, compliant product launches and changes within an established budget.

  • Responsible for defining the project charter, including scope, resource allocation (people and financial), critical deliverables and target timelines for new product development and significant continuous improvement projects.
  • Manage the integrated project schedule, prioritize the project tasks, and ensure clear, consistent communication of priorities across all cross-functional teams.
  • Define, maintain, and report project budget status and expenses. Lead regular product cost reviews to identify, track, and mitigate product specification variances that impact manufacturing cost of goods (COGs).
  • Ensure meticulous execution of the projects in adherence to Design Control procedures, ensuring all phase gate documentation (e.g., Design History File sections) is complete, accurate, and audit-ready.
  • Proactively identify, analyze, and mitigate project risks (technical, schedule, compliance, and budget) that threaten product safety, efficacy, or commercial launch.
  • Actively participate in Quality Improvement teams and advocate for continuous improvements to the Quality Management System (QMS) and product development processes, using quality tools (e.g., FMEA, root cause analysis) as required. Provide strategic direction for both technology advances and product introductions, while remaining technically abreast of changes, advancements, or improvements within the field.
  • Prioritize the project tasks and communicate priorities across cross-functional teams. Define, maintain, and report project schedules and expenses / budget status.
  • Identify and report potential product specification variances, working with the project team to perform regular product cost reviews and report on results.
  • Ensure compliance with quality system requirements for development with particular attention to risk management throughout the development and implementation processes.
  • Responsible for keeping technically abreast of changes, advancements, or improvements within area of assignment, discipline or specialization, incorporating these improvements where applicable.
  • Apply quality improvement process-related tools as required in problem-solving and decision-making, and participate actively in quality improvement teams.
  • Bachelors Degree in Engineering, Chemistry, Computer Science or other similar technical field
  • 5-10 years' experience, preferably in the Medical Device product development industry
  • At least two years experience in a project leadership position in the medical device industry, having demonstrated success at leading projects from concept to definition, through execution, and to completion
  • Proficiency in project accounting (budget creation and tracking), risk analysis, and simultaneous management of multiple projects
  • Excellent written and oral communication and presentation skills, capable of translating complex technical information for executive, technical, and non-technical audiences
  • Strong analytical and critical thinking skills with the ability to drive data-informed, assertive decisions with appropriate rationale
  • Proficient in an MS Office environment with effective use of project management tools such as WBS and MS Project
  • Must be a hands-on manager that is an integral part of the development team without micro-managing
  • Exceptional project-leadership and interpersonal skills necessary to motivate, drive, and maintain high morale within cross-functional teams under aggressive deadlines
  • Proven ability to manage projects in a cross-functional / matrixed environment
  • Ability to travel up to 30% annually via car and air
  • Valid identification for air travel w/in the United States and internationally
  • Experience managing projects involving software development teams, ideally utilizing Agile methodologies (scrum).
  • Hands-on leadership style with a proven track record of mentorship and team integration, avoiding micromanagement.
  • Experience with implantable/Class III medical devices incorporating both hardware and firmware/software
  • Competitive Health & Dental Insurance options with generous Company contributions
  • Company contributions to an HSA with a high-deductible insurance plan selection
  • 401(k) with a company match
  • Employee stock purchase plan (ESPP) & stock option grants
  • 12 company-paid holidays per year in addition to a generous Flex PTO plan
  • Generous paid time off for new parents
  • Company-paid life insurance & disability options
  • Unlimited growth opportunities in a growing company
  • Endless training & learning opportunities
  • Flexible Schedule
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