Sr Engineer

Plymouth, MA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 dont 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:

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 . 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)) Product / Project Management (Applying / Overseeing (2)) Smart Operations / Industry 4.0 (Learning / Doing (1)) Software Integration (API Data Pipelines) (Not Applicable (0))

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) Vantives 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 additional information regarding Vantives 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.

Know Your Rights: Workplace Discrimination is Illegal

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams where fraudulent parties pose as Vantive employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.

Required Experience:

Senior IC