Sr R&D Project Manager

VitalPath•Saint Paul, MN

1d•$112,000 - $150,000•Onsite

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.

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%

Nice To Haves

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

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