Seeking to hire a Manufacturing Engineer for a growing Medical Device company in DFW!
Job Description:
In the last phase of production and hoping to launch the line eventually. A lot of things they make they source from other suppliers. They are finished
with the line duplication at their CA facility (fixtures built) and now they need to work on process and work instructions.
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, quality improvements.
Responsible for selection, installation, qualification (IQ/PQ/OQ) of 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.
Documents project activities.
Participate in the selection and qualification of new suppliers. Works 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. **Regular attendance required.
Additional Skills & Qualifications
Good communication and interaction is critical. Implantable preferred. GMP. Support activities like IQ/PQ/OQ. Dealing with Rework and documenting them without impacting the quality of their products.
Bachelors Degree, preferably in an Engineering discipline.
Solidworks CAD experience
Working knowledge of Microsoft applications including MS Project.
Minimum 3 years prior Manufacturing Engineering experience in a medical device or pharmaceutical environment.
Strong problem solving skills.
Effective communication skills.
Self motivated.
Ability to work effectively under pressure to meet deadlines.
Solid organizational skills-able to handle multiple tasks simultaneously.
Nonessential Skills,
Experience and Qualifications(not necessary but preferred):
Pro-E CAD software experience.
CNC swiss programming/machining
Machine tooling design
Familiarity with ORACLE and Agile Manufacturing applications.
Experience in a Lean Manufacturing environment.
Six Sigma Greenbelt Certification
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About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.