Sr Engineer

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.

Job Title:

Sr. Engineer – Disposables R&D

Job Profile:

Prof II- Engineering – General Engineering

Group - Family:

Engineering – General Engineering

FLSA:

Exempt

Grade:

16

Summary:

This section focuses on the main purpose of the job in one to four sentences.

Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices.

Essential Duties and Responsibilities:

This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

• Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes and product development (e.g. new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).

• Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).

• Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.

• Develop and execute test method validations, product testing, and verification / validation activities.

• Build prototypes and models.  May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.

• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization. 

• Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).

• Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.

• Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.

• Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.

• Strong collaboration, verbal and written communication skills.

• Strong attention to detail, organized, and able to independently manage multiple priorities.

• Ability to read, write and comprehend English.
 

Experience and/or Background

BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.

• 3 - 5 years of related experience in Class II or Class III disposables medical product development.

• Design for Six Sigma (DFSS) training or certification preferred.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Learning / Doing (1)), Process Automation (Applying / Overseeing (2)), Pr