Sr. Engineer - R&D Disposables (hybrid)

About the role

Vantive is a vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams. We have a rich history in kidney care dating back 70 years and are now expanding our focus to transform vital organ therapies. Our goal is to provide greater flexibility and efficiency in therapy administration for care teams and longer, fuller lives for patients.

Responsibilities

• Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (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

Requirements

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering or a related field; advanced degree is a plus
• 3+ years of related experience in Class II or Class III disposables medical product development
• Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
• Working knowledge of CAD 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

Qualifications

• 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
• Reads, writes, and comprehends English
• Design for Six Sigma (DFSS) training or certification (preferred)

Skills

• 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))
• Instrumentation (Leading / Driving (4))
• Lean & six sigma process knowledge (Applying / Overseeing (2))
• Machine Learning & Artificial Intelligence (Not Applicable (0))
• Manufacturing & Process Knowledge (Applying / Overseeing (2))
• Manufacturing Process Knowledge (Managing / Facilitating (3))
• Modeling & Simulation (Leading / Driving (4))
• Operational Quality Assurance (Learning / Doing (1))
• Process Automation (Applying / Overseeing (2))
• Product / Project Management (Applying / Overseeing (2))
• Product Knowledge (Managing / Facilitating (3))
• Quality Management Systems (Managing / Facilitating (3))
• Regulatory Compliance (Leading / Driving (4))
• Smart Operations / Industry 4.0 (Learning / Doing (1))
• Software Integration (API, Data Pipelines) (Not Applicable (0))
• Software Process Management (Leading / Driving (4))
• Sterilization methods (Leading / Driving (4))
• Systems Validation (Leading / Driving (4))

Benefits

• Comprehensive compensation and benefits packages including medical, dental, and vision coverage, as well as insurance for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Aon Pooled Employer Plan (“Aon PEP”) for retirement savings
• 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 including commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits

Pay

The estimated base salary for this position is $88,000 to $121,000 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.

Schedule

This position may also be eligible for discretionary bonuses, and/or long-term incentive. 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.

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.