Director of Operations (Medical Device Manufacturing)

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body’s 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.

This is a full-time role and our selected candidate will be expected to work a minimum of 4 days per week onsite at our Brooklyn Park, MN headquarters.

A day in the life:

As we continue to mature and grow, CVRx is seeking to add an influential and strategic Senior Director of Operations to lead with vision and precision. This role is more than managing day-to-day execution, it’s about owning the performance, scalability and future development of a critical product – Barostim®. You’ll review, design and drive operational strategy, transforming KPIs into tangible impact and delivering measurable results in a fast-paced, growth-stage environment.  If you thrive on creating clarity, and scaling excellence from the ground up, this is your opportunity to help shape the future of heart failure therapy innovation.

Key Duties and Responsibilities:

Operational Strategy Development and Execution

·        Be accountable for Safety, Quality, and Delivery of Barostim®.

• Lead manufacturing operations, ensuring efficient production and compliance with quality standards.
• Lead Supply Chain and Distribution (including sourcing, planning, product distribution).
• Develop and execute multi-year operational strategies aligned with business goals and financial decisions at the board level.
• Translate long-range plans into KPIs, objectives, projects, and budgets.
• Maintain a project management system to ensure strategic goals and SQDC metrics are met.
• Provide leadership to cross-functional manufacturing and engineering teams.
• Own and manage area budgets, product forecasting, and scheduling for internal and outsourced products.

Supply Chain & Manufacturing

• Oversee complex, global supply chains, including supplier qualification, outsourcing strategy, and risk mitigation in a highly regulated environment.
• Manage / integrate contract manufacturing partners (CMOs) and third-party logistics providers as needed.

Continuous Improvement

• Deploying operational project management structure.
• Optimize productivity and reduce costs by implementing manufacturing best practices.
• Drive continuous improvement across the organization.
• Build long-range models for forecasting OCOGs, staffing, space, and site capacity.
• Lead and support Kaizen and cross-functional improvement initiatives.

Culture and Talent Development

• Create a workplace where team members are empowered to innovate, improve, and make a meaningful impact on our patients’ lives.
• Identify and develop top talent in partnership with HR, TA and department managers.
• Promote cross-functional collaboration across operations.
• Build a strong leadership pipeline through targeted development initiatives.

What we expect from you:

• Bachelor’s degree in engineering, operations management, or related field required
• 10+ years of progressive leadership in Operations and Engineering within the medical device industry
• In-depth knowledge of FDA regulations, ISO standards, and relevant industry guidelines.
• Deep expertise in various manufacturing methodologies including LEAN Manufacturing and Continuous Improvement
• Experience scaling operations during periods of organizational growth, ideally in a start-up or scale-up environment
• Proven track record in leading transformational change initiatives
• Success in developing leaders as well as building team structures during organizational evolution or transformation
• Strong understanding of regulatory impact on processes and alignment between functional operations and business strategy
• Collaborative, servant leader with a track record of building cross-functional partnerships
• Strong financial acumen
• Willingness to travel; expected travel ~ 20%
• Career aspirations in leadership
• A valid form of approved dentification for Air Travel is required
  

Required Skills

• Operational Strategy development
• Global Supply Chain Management
• Distribution
• LEAN Manufacturing and Continuous Improvement Methodologies
• Talent Development and Leadership acumen

What we would like to see:

• MBA or advanced degree preferred
• Experience in device manufacturing for cardiology, cardiovascular or heart failure space

Working Conditions:

• Work is performed in a normal R&D laboratory, controlled assembly area, and clean room environments
• Capability of lifting light loads
• Ability to travel for business as required
• May be required to be fully vaccinated against the COVID-19 virus and other diseases

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 (or Hourly) range for U.S locations (USD): 179,000 -245,000

In addition to Base Salary, this position is eligible for our Corporate Bonus Plan (CBP) which provides the opportunity to earn additional compensation for the company’s 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 & stock option grants
• 12 company-paid holidays per year in addition to our generous Flex PTO plan
• Generous paid time off for new parents
• Company-paid life insurance & disability options
• Unlimited growth opportunities
• Training & learning opportunities
• Flexible Schedules

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 [email protected]. 

This requisition will be open until filled.