Actalent Manufacturing Engineer in NEWBURY PARK, California
Develop manufacturing processes, work instructions, routings and develop necessary production tooling.
Be a key contributor in the creation of PFMEAs.
Support production builds.
Perform root cause analysis to resolve manufacturing and production system downtimes and provide technical information to support corrective actions and improvements.
Develop and qualify specialized assembly tooling and equipment (IQ, OQ, PQ)
Write and execute test protocols.
Analyze process data to reduce material scrap and to optimize processes.
Document all manufacturing processes in accordance with our ISO standards.
Interface with outside vendors for manufacturing, measurement, and test equipment selection.
Read and interpret technical drawings, product specifications, technical and regulatory requirements, and computer-generated reports.
Leading and implementing Lean initiatives that include designing and implementing continuous improvements, developing best practices, measuring process improvements, and establishing visual management and ensure implementation of best practices for production.
Apply statistical methods and perform mathematical calculations to determine manufacturing processes, staff requirements, production standards, value stream mapping, Kaizen, Kanban, setup time reduction, single piece / small batch process flow, 5S process, machine capability studies, Cpk/Ppk, X-Bar&R charts, establish control limits, etc.
control plans, inspection plans, medical device, plastic, validation, iq oq, cnc machine, plastic injection molding, pfmea, new product introduction, process development/improvement
Top Skills Details:
control plans, inspection plans, medical device, plastic
Additional Skills & Qualifications:
• Bachelor’s Degree in Engineering or equivalent (Mechanical preferred)
• Minimum five (5) years of manufacturing engineering experience in a controlled environment such as ISO 13485
• Experience with ERP systems
• Proficient in Solid Works CAD Software
• Experience with the generation, release, and change control of various document types.
• Strong verbal and written communication skills
• Strong troubleshooting and evaluation intuitiveness
• Excellent problem solving and time management skills
• Works precisely and pays close attention to details
• Strong mechanical aptitude and knowledge
• Self-motivated and highly organized
• Good interpersonal skills, tactful, mature and flexible
• Strong supporter and an advocate of company values.
• Knowledge of electronic equipment and computer hardware and software, Excel, MS office
• Strong knowledge of LEAN, Six-Sigma, SPC, Shainin, and other process capability and problem solving tools.
• Experience in the Medical Device industry
• Experience with precision machining and machine tools
• Knowledge of automated assembly equipment and techniques.
• Experience with plastic injection molding and injection molding systems
• Proficient with Design For Manufacturability (DFM) practices and LEAN Manufacturing principles
• Familiar with ultrasonic welding of plastic materials
• Knowledge of material cleaning and passivation processes
• Clean room assembly practice (cGMP) experience
• Laser marking of plastic and stainless steel
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.