Project Manager - (Medical Device Research & Development) - Hybrid in Minneapolis, MN at CVRx – Brooklyn Park, Minnesota
CVRx
Brooklyn Park, Minnesota, 55428, United States
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About This Position
Project Manager - (Medical Device Research & Development) - Hybrid in Minneapolis, MN
Why work for CVRx?
CVRx pioneers' unique therapies that harness and harmonize the bodys natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.
The Role
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.
Key Duties & 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.
- Bachelor's degree in Engineering, Chemistry, Computer Science or another similar technical field
- 5-10 years' experience, preferably in the Medical Device project development with emphasis in medical device development
- Demonstrated success at designing and leading projects; from concept to definition, through execution, 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
- Normal hybrid and in-office working conditions
- Capability of lifting light loads up to 15 lbs
- Occasional driving may be required
- Occasional travel (including airline) up to 30% of the time; including international travel
WHAT WE OFFER
CVRx is proud to offer competitive salaries and benefits plans. We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun.
Salary range for U.S locations (USD): 115,000 -135,000 per year
In addition to Base Salary, this position is eligible for a Corporate Bonus Plan (CBP) which provides the opportunity to earn additional compensation for the companys meeting established annual objectives and prorated based on earned annual base salary.
The base salary range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.
We also offer a competitive benefits package, details listed below:
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
EEO STATEMENT
CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!
If you need assistance or an accommodation due to a disability, you may contact us at hiring@cvrx.com
This requisition will be open until filled.
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Job Location
Brooklyn Park, Minnesota, 55428, United States
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