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Sr R&D Project Manager

4 months ago

Minneapolis, United States VitalPath Full time
Job DescriptionJob Description

Join VitalPath in New Hope as a Sr R&D Project Manager

About VitalPath
VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team

About the Position
The Senior Research & Development (R&D) Project Manager will be responsible for leading complex development projects. This position will serve as the primary customer contact throughout the duration of the project, act as a key technical resource while also driving a cross-functional team to successfully meet project requirement on schedule and within budget. This position is responsible for ensuring that all deliverables within the scope of the project are completed in accordance with VitalPath’s Quality Management System (QMS) and are compliant with FDA QSR (21 CFR 820), and applicable ISO 13485 requirements.

Responsibilities

  • Manage the scope, schedule and budget of complex, technically challenging customer facing projects based on the definition of agreed upon customer quotes/proposals
  • Effectively manage multiple complex projects of varying size, particularly of more challenging timeline, technical or customer nature
  • Lead cross-functional teams by delegating responsibility and establishing accountability to drive multiple projects to completion
  • Establish and maintain excellent customer relationships through expectation management and regular communication including but not limited to reoccurring project meetings, project health reports and status updates
  • Identify creative opportunities to add value to individual customers’ programs and products and provide value for VitalPath, beyond defined project scope and constraints
  • Responsible for training, managing, and motivating the project team, as well as resolving team conflicts
  • Collaborate with business development in evaluating new project opportunities, including defining realistic project requirements to support the development of accurate quotes/proposals
  • Lead and participate in technical design reviews and phase reviews
  • Identify project and business risks and define and implement agreed upon risk mitigation plans
  • Ensure compliance with Product Development Process in accordance with internal and customer Quality Management Systems (QMS)
  • Drive the impeccable documentation of design control documents and project decisions to create comprehensive Design History Files for projects
  • Partner with engineering team members to identify and execute opportunities for continual process improvement in VitalPath product development processes
  • Serve as an additional technical, engineering resource for projects as required; Mitigate project risk by identifying and proposing solutions to technical challenges
  • Collaborate with management to execute resources planning and communicate expected revenue targets based on project goals and schedules
  • Actively develop team members and share knowledge to support the growth of organizational capabilities and skills
  • Mentor Research & Development Engineers in the management of small-scale projects
  • Other duties as assigned
Requirements
  • Bachelor’s degree in relevant engineering or other technical discipline
  • Minimum 10 years’ experience in product development of relevant medical devices and 3 years of customer facing medical device project management experience, contract manufacturing a plus
  • Demonstrated ability to communicate complex technical ideas in a concise and effective manner, both written and verbal, to internal and external project stakeholders
  • Working knowledge of minimally invasive medical device design, development, and manufacturing processes
  • Strong interpersonal skills and ability to lead and influence team members with or without formal authority
  • Experience with project management methodologies and tools including schedule, budget, and resource management techniques
  • Proficient with Microsoft Office programs including Word, Excel, PowerPoint, Outlook, and Teams
  • Must be able to sit and/or stand for an extended period of time
  • Willingness to travel up to 15%
Preferred Skills & Experience
  • Bachelor’s degree in Plastics, Biomedical or Mechanical Engineering
  • Demonstrated track record of leading high performing technical teams working on the development of complex medical devices
  • Working knowledge of design control and both FDA and ISO regulations
  • Formal project management: PMP certification preferred
  • Experience managing projects through all phases of the product life cycle from initial concept through transfer to manufacturing
  • Experience with Microsoft Project or similar software
Benefits
  • Comprehensive, Low Cost Health and Dental Insurance Plans Available
  • Vision Insurance
  • Health Savings Account with company contribution
  • Short and Long Term Disability
  • Supplemental insurances (short term disability, AD&D, life insurance, and more)
  • Paid Time Off
  • Paid Holidays
  • 401K with company match
  • Competitive compensation
  • Opportunities for career growth and advancement

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.

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