R&D Project Leader II - LSI

Vantive • Plymouth, MN

1d • $108,000 - $135,000 • Hybrid

About The Position

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Vantive provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Vantive’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Your Role: Lead System Integration (LSI) team is a part of the R&D organization that supports project management activities in innovation initiatives, new product development and improvement programs for existing therapy systems. Lead System Integrator co-ordinates/leads R&D team within a Project or Program with her/his Project Management and Technical Leadership skills. The LSI serves as the central coordination point for cross-functional engineering teams, driving execution of integration strategy, risk management, and schedule alignment to deliver safe, effective, and compliant medical devices. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Vantive’s mission to extending lives and expanding possibilities.

Requirements

• Bachelors degree in Engineering or equivalent field.
• Minimum of 3 years’ experience in project or program management, and 5 years’ experience in medical device industry.
• Strong understanding of medical device design controls and regulatory frameworks.
• Demonstrated experience coordinating cross-functional engineering teams.
• Experience in project management principles and methodologies.
• Strong interpersonal and communication skills in written and verbal form.
• Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.).
• Ability to provide technical leadership for medical device projects with substantial complexity and scope.
• Ability to decompose complex problems into actionable task lists.
• Understanding of design requirements for development, validation, and verification of medical products.

Responsibilities

• Lead research and development (R&D) project management work, and research for medical devices and regulated healthcare products.
• Owner of R&D program schedule creation, tracking, and execution.
• Responsible for delivering an integrated product with detailed plans from primary iteration to successful system verification completion.
• Monitor technical progress, identify critical path risks, and implement mitigation plans.
• Drive execution of system integration strategy across cross functional engineering teams.
• Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Prepares project reports, analyses and delivers presentations to R&D leadership on a weekly basis.
• Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the integration steps.
• Ensure timely resolution of cross-functional dependencies and technical conflicts.
• Facilitate/organize integration planning sessions, technical design reviews and change control meetings.
• Release POs and approve corresponding invoices for the R&D tasks executed by external vendors (e.g., external labs, translation agencies, etc.)

Benefits

• Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level