Job Title: Validation Engineers

Job Description

As a Validation Engineer, you will develop, document, evaluate, monitor, and improve manufacturing processes. You will work with the Design Team to ensure manufacturability and effective transition of new products to commercialization. Your role involves preparing and presenting return on investment proposals (ROI) for management review, selecting and installing tooling and capital equipment, defining maintenance activities and intervals, and creating project schedules. Additionally, you will participate in the selection and qualification of new suppliers, conduct research, feasibility testing, and process validation, and provide progress reports to management.

Responsibilities

• Develop, document, evaluate, monitor, and improve manufacturing processes.

• Work with the Design Team to ensure manufacturability and effective transition of new products to commercialization.

• Prepare and present return on investment proposals (ROI) for management review regarding anticipated capital equipment purchases, process improvements, and quality improvements.

• Select, install, and qualify tooling and/or capital equipment utilized in product manufacture.

• Define tooling and equipment maintenance activities and intervals.

• Create project schedules and provide budgetary input for cost reduction and new product projects.

• Participate in the selection and qualification of new suppliers.

• Work closely with suppliers, purchasing, and development to ensure design requirements are adequately defined and met.

• Ensure new product manufacturability by conducting research, feasibility testing, and process validation.

• Conduct and document verification/validation/engineering testing.

• Conduct time studies to determine accurate labor standards for products supported.

• Set up workflow routers and bill of materials in ORACLE/AGILE database.

• Track and document actual vs. labor standards.

• Generate and implement Engineering Change Orders.

• Support production by developing shop aides/fixtures, manufacturing procedures, drawings & specification interpretation.

• Provide progress reports to management as required.

• Monitor and provide periodic reports on component product quality and take appropriate action to reduce costs due to defects.

• Lead cross-functional teams for the purpose of post-market and continuous improvement activities.

Essential Skills

• Bachelor's Degree, preferably in an Engineering discipline.

• Solidworks CAD experience.

• Minimum 3 years prior Manufacturing Engineering experience in a medical device or pharmaceutical environment.

• Experience with design transfer and DFM.

• Support activities such as IQ/PQ/OQ.

• Solidworks or Pro-E CAD software experience.

• CNC swiss programming/machining validation.

• Familiarity with ORACLE and Agile Manufacturing applications.

• Experience in a Lean Manufacturing environment.

• Six Sigma Greenbelt Certification.

Pay and Benefits

The pay range for this position is $40.00 - $55.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Lewisville,TX.

Application Deadline

This position will be accepting applications until Feb 7, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.