R&D Project Engineer - VitalPath

Join VitalPath in New Hope as a Research & Development Project Engineer!

About VitalPath

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.

Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence.

As a fast-growing organization, we bring harmony and standardization across VitalPath with a strong vision in mind - We are one VitalPath. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that VitalPath is an employer of choice. If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!
 

About the Position

The Research & Development (R&D) Project Engineer will be responsible for leading development projects. This position will serve as the primary customer contact throughout the duration of the project, act as a key technical team member 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 moderate complexity, technically challenging customer facing projects based on the definition of agreed upon customer quotes/proposals
• Effectively manage multiple projects and customers, generally of medium size and complexity 
• Establish and maintain excellent customer relationships through regular communication including but not limited to reoccurring project meetings, project health reports and emailed 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 when necessary
• Partner with business development in evaluating new project opportunities, including defining realistic project requirements to support the development of accurate quotes/proposals
• 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
• 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
• Other duties as assigned

Requirements

• Bachelor’s Degree in relevant engineering or other technical discipline required, or equivalent amount of experience
• Minimum 5 years’ experience in product development of relevant medical devices and 1 year of project leadership
• Demonstrated ability to communicate complex technical ideas in a concise and effective manner, both written and verbally, 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 motivate team members who are not direct reports
• 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/stand for an extended period of time

Preferred

• Bachelor’s Degree in Plastics, Biomedical or Mechanical Engineering preferred
• 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 experience
• 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
• Willingness to travel up to 15%

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
• Minnesota Earned Sick & Safe 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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