R&D Engineer (Recent College Graduates Preferred) Local Candidates

MillenniumSoft Inc; Tempe (AZ); Presencial; USD 42.000 - 62.000; Jornada completa

Descripción de la vacante

MillenniumSoft Inc. is seeking an R&D Engineer (Recent College Graduates Preferred) for a nine-month contract in Tempe, AZ. The role focuses on assisting medical device process development, testing, and data analysis in a regulated environment.

The position is entry level, 40 hours per week, first shift, pay rate $20-$30/hr, and requires US citizenship or GC. Local candidates only.

Formación

• High school diploma or GED required.
• 1–3 years of industrial R&D or process development experience.
• FDA/QSR and ISO environment experience preferred.
• Lab/cleanroom experience with GMP/GLP knowledge is a plus.
• Proficient with data analysis tools (e.g., Minitab) and MS Office.

Responsabilidades

• Assist R&D engineer with process development and testing.
• Develop, optimize, and validate processes for medical device builds.
• Build units for engineering evaluation and studies.
• Perform tests, collect data, and present findings.
• Adhere to GMP/quality requirements and maintain documentation.
• Set up and operate manufacturing equipment.
• Provide process/test method training to manufacturing and QA personnel.
• Maintain and inspect equipment; obtain quotes for testing/calibration.

Conocimientos

MS Windows

MS Outlook

MS Word

MS Excel

MS PowerPoint

Microsoft Project

Minitab

Data analysis

Statistical methods

Educación

High school diploma/GED

Associates degree in science/math/engineering

Herramientas

SolidWorks

CAD drawings

Descripción del empleo

Position : R&D Engineer (Recent College Graduates Preferred) Local Candidates

Location : Tempe, AZ

Duration : 9 Months

Total Hours/week : 40.00

pay rate-$20-30/hr

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description

• Primary focus of this position is to assist R&D engineer medical device process development and testing.
• This would include developing, optimizing, and validating processes for building a medical device; building units for engineering; performing tests, and collecting and analyzing data.
• While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment.
• The employee frequently is required to verbally communicate with other associates.
• While performing the duties of this job, the employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Essential / Key Job Responsibilities

• Product Builds: Assist, coordinate, track and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing, and commercial sales.
• Sets up and operates manufacturing equipment.
• Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development.
• Assists in conceptual input to the design of fixtures, tooling, and equipment, as well as assists with recommendation, specification, and procurement of capital equipment.
• Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and formal test protocols and reports which comply with GMP and Quality requirements.
• Test Method Development: Review test methods during test method development and assists with test method validations.
• Testing: Ability to perform tests by following instructions from development engineers; collect data and record test results; analyzing test data, organizing and presenting when it is necessary in a reportable format. Assists in the execution of test protocols and procedures. Sets up test equipment for testing to protocols.
• Training: Provides process/test method training to manufacturing and QA personnel.
• Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule.
• Ensure equipment is operating properly. Obtaining quotes for testing and calibration.

Required Qualifications

• Minimum of a Highschool Diploma/GED. Associates of Science degree in science, math or engineering preferred.
• Experience: 1-3 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 1-2 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment. Ability to work with little supervision.
• Experience working in a laboratory and a controlled environment (cleanroom) with knowledge of GMP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for test or pilot processes, is a plus.
• Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel, and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.
• Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis.
• Ability to design (fixture, equipment, and testing). Has general technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g., Solid works).