Engineering Specialist

Position: Engineering Specialist-2
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.

Your Role:

This position is part of the Solutions and Containers R&D Team, Drug Products - Americas, within the Product Development Lifecycle Management and Sustaining Product Organization.

The Engineer Specialist provides senior technical leadership across global, cross-functional projects spanning all kidney care modalities (Peritoneal Dialysis, Hemodialysis, and Acute Care).

The role supports new product development, material and design changes, and lifecycle management, with a strong focus on container-solution systems, regulatory compliance, and patient safety. The Engineer Specialist is expected to operate as a technical authority, driving complex problem-solving, influencing strategy, and mentoring engineers while delivering robust, compliant solutions that support business continuity and improved patient outcomes.

What you'll be doing:

Technical Leadership & Strategy

• Serve as a recognized technical authority and subject matter expert in container and solution technologies, influencing product, platform, and program strategy across the organization.
• Lead the resolution of complex, ambiguous, and platform-level technical challenges, applying structured problem-solving and risk-based decision making.
• Contribute to design concepts, research methodologies, and technology strategies that address current and future customer, patient, and business needs.
• Act as a key technical influencer in product and platform roadmap development.

Product Development & Execution

• Define, plan, and execute activities for new product development and sustaining projects, ensuring delivery against scope, quality, and regulatory requirements.
• Lead multiple technical work streams simultaneously, maintaining accountability for results, timelines, and technical integrity.
• Translate user needs, hazards, risks, and business objectives into robust product and process designs.
• Plan and execute technical studies and evaluations, ensuring scientific rigor and compliance.
• Coordinate technical activities with internal teams, external partners, suppliers, and customers to meet project and business objectives.

Regulatory, Quality & Design Control Excellence

• Ensure compliance with global regulatory and quality requirements for drug products and medical devices, including FDA, ISO, ICH, cGxPs, and applicable pharmacopeial standards (USP, EP, JP, etc).
• Drive adherence to design control processes, including ownership and maintenance of Design History Files and associated technical documentation.
• Establish, maintain, and update technical and design documentation in accordance with Good Documentation Practices.
• Support regulatory interactions as required, including audit support and regulatory submissions or responses.

Risk Management & Business Acumen

• Proactively identify technical, regulatory, and execution risks and lead the development and implementation of effective mitigation strategies.
• Apply sound business judgment in balancing cost, risk, profitability, and vendor relationships while supporting long-term product sustainability.
• Think holistically across products, platforms, and manufacturing networks to support business continuity and supply resilience.

Collaboration, Influence & Talent Development

• Collaborate effectively across global, cross-functional, and multicultural teams, adapting leadership and communication styles to drive alignment and results.
• Maintain clear, effective communication with stakeholders at all levels, providing transparent technical assessments and status updates.
• Mentor, coach, and develop engineers, strengthening technical depth, strategic thinking, and problem-solving capabilities within the team.
• Foster a collaborative, inclusive, and high-performance technical culture.

What you'll bring:

• PhD (preferred) or Master's (required) in Materials Science, Materials Engineering, Polymer Chemistry, Polymer Engineering, Chemical Engineering, Biosciences, Biomedical Engineering, or a related field.
• Minimum 8+ years of relevant industrial experience in drug products, medical…