Sr. Engineer - Disposables R&D, Sustaining - Hybrid

Company: Viva USA Inc.
Location: Minneapolis
Posted on: May 8, 2025

Job Description:

Title: Sr. Engineer - Disposables R&D, Sustaining - Hybrid

Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.













Mandatory skills:

Medical Device, medical product development,
Design for Six Sigma,
CAD, PDM enterprise software, Creo, Solidworks,
FDA Design Controls, ISO, Quality Management Systems,
ANSI, AAMI, Risk Management, FMEA, Human Factors Engineering, statistical software,
plastics materials, plastics processing, injection molding, extrusion, ultrasonic welding, UV, solvent bonding, sterilization,
design changes, suppliers, materials, labeling, CAPA, NCR, cost reduction, remediation,
file documentation, protocols, reports, design specifications, labeling, design drawings,
product changes, test method validations, product testing, product verification, product validation,
machine tools, design, tooling, test fixtures, assembly equipment, design control procedures, safety rules,
implement, continuous improvement, communication, organization, investigation, problem solving












Description:


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, 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 (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 accommodation 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 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.

Notes:
Workers can be remote/hybrid but must be able to come into the office at least three days a week
Shift - 1











VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at hr@viva-it.com for any complaints, comments and suggestions.




Contact Details :

Account co-ordinator: Godwin D Antony Raj, Phone No: (847) 607-1014, Email id: staffing10@viva-it.com

VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
staffing10@viva-it.com - http://www.viva-it.com
Remote working/work at home options are available for this role.

Keywords: Viva USA Inc., Rochester , Sr. Engineer - Disposables R&D, Sustaining - Hybrid, Engineering , Minneapolis, Minnesota