Engineering Specialist-1

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 workstreams 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 devices, combination products, or related regulated environments.
  
• Deep expertise in polymeric materials for medical and pharmaceutical applications, including container and drug/device combinations.
  
• Strong knowledge of material qualification, product development, and lifecycle management for pharmaceutical packaging or disposables.
  
• Demonstrated technical leadership in global, cross-functional project environments.
  
• Expertise in design control documentation, including Design History Files.
  
• Strong understanding of manufacturing processes and process optimization, preferably for parenteral or combination products.
  
• Proven experience in technical risk assessment, mitigation, and execution.
  
• Strong analytical skills, including familiarity with statistical methods and Six Sigma tools.
  
• Excellent written and verbal communication skills, with the ability to influence technical and business decisions at all organizational levels.
  

Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $152,000 to $190,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. 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. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

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. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.


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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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