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CVRx | Barostim · 3 weeks ago

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

Brooklyn Park, MN

Full-time

Hybrid

Senior Level

$115K/yr - $135K/yr

5+ years exp

CVRx, Inc. is a company focused on innovative medical devices, and they are seeking a Project Manager to lead complex projects through the product lifecycle. The role involves driving project execution, managing cross-functional teams, and ensuring compliance with development processes to launch viable products on time and within budget.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device

Growth Opportunities

Responsibilities

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

Qualification

Medical Device DevelopmentBudget ManagementRisk AnalysisProject ManagementQuality Management SystemMS ProjectAgile MethodologiesAnalytical SkillsInterpersonal SkillsCommunication Skills

Required

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