Engineer I - R&D Disposables (hybrid)

Vantive; Minneapolis (MN); Sur place; USD 76 000 - 95 000; Plein temps

Avantages offerts par ce poste

Health benefits

401(k) retirement plan

Paid time off

Paid parental leave

Flexible Spending Accounts

Commuting benefits

Employee discount program

Résumé du poste

Vantive in Minneapolis, MN is seeking an engineer to support sustaining engineering and new product development for disposable medical devices. You will help implement design changes, maintain design history files, and perform validations across R&D projects.

The role requires a BS in engineering, 0–2+ years in Class II/III disposables, CAD experience (Creo/SolidWorks), and strong communication skills. Competitive base salary with bonuses and comprehensive US benefits.

Qualifications

• 0–2+ years of related experience in Class II or Class III disposables medical product development.
• BS in Mechanical, Plastics, Biomedical Engineering or related field.
• Understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Design for Six Sigma (DFSS) training or certification preferred

Responsabilités

• Support R&D projects in implementing design changes and product development (new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
• Identify, investigate, and solve engineering problems using 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 drawings.
• Support 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, safety rules, company policies and FDA/ISO regulations.

Connaissances

Strong collaboration

Verbal and written communication

Attention to detail

Initiative and adaptability

English reading/writing

Formation

BS in Mechanical, Plastics, Biomedical Engineering or related field

MS preferred

Outils

Creo

SolidWorks

CAD design tools

PDM software

Description du poste

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

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

What You’ll Be Doing

• Support R&D projects 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.
• Support 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.

What You’ll Bring

• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
• 0 – 2+ years of related experience in Class II or Class III disposables medical product development.
• Design for Six Sigma (DFSS) training or certification preferred
• Understanding 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).
• Understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Understanding of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
• Takes initiative with a high aptitude for learning, innovation, 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.

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 $76,000 to $95,000 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

Advanced Molding and Extrusion techniques (Learning / Doing (1)), 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)), Data Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Graphic Design (Not Applicable (0)), Instrumentation (Managing / Facilitating (3)), IT & Industry Standards. Packaging Process (Applying / Overseeing (2)), 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)), Product Lifecycle Management (Not Applicable (0)), Project Management (Applying / Overseeing (2)), Quality Control (Not Applicable (0)), Quality Management System (Learning / Doing (1)), Quality Management Systems (Managing / Facilitating (3)) {+ 7 more}

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.

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.