Principal Engineer - Disposables R&D, Sustaining - Hybrid

Title: Principal Engineer - Disposables R&D, Sustaining - Hybrid

Mandatory skills:

FDA Design Controls, ISO, Quality Management Systems,
CAD design, PDM enterprise software, Creo, Solidworks,
R&D, ANSI, AAMI, Medical Device, Risk Management,
plastics materials, plastics processing, injection molding, extrusion, ultrasonic welding, UV, solvent bonding, sterilization,
technical risk, technical expertise, continuous improvement, design control procedure, safety rules,
product changes, engineering projects, products, suppliers, materials, labeling, CAPA, NCR, cost reduction, remediation,
FMEA, Human Factors Engineering, statistical software, product changes,
problem solving, develop, implement, communication, collaboration, schedule, budget, investigation

Description:

Summary:
This section focuses on the main purpose of the job in one to four sentences.
Leads 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.
Schedule, budget, and lead engineering projects with minimal guidance.
Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
Lead the creation and maintenance of design history files.
Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
May supervise engineers and/or technicians.
May contribute to the client intellectual property through invention disclosures and patent applications.

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.

Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).
Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
Creative Problem Solver identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
Ability to train and coach others from technical expertise.
Self-directed, resourceful, and able to manage multiple priorities.
Strong interpersonal, communication, collaboration and influencing skills.
Ability to read, write and comprehend English.

Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
5 - 8 years of related experience in Class II or Class III disposables medical product development.

Note:
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 for any complaints, comments and suggestions.

Contact Details :

VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008