MANUFACTURING ENGINEER II
Job Description
Your tasks
Work collaboratively with engineers and customer personnel to design and develop silicone extrusion and molding processes using existing and innovative technologies.
Develop process validation protocols and reports, in accordance with applicable corporate procedures and in conjunction with senior engineers and the customer project team.
Specify new and existing product processes at a high level through the creation of process flowcharts and diagrams.
Create bills of materials, manufacturing procedures, and routers for components, assemblies, packaging, labeling, and other documents needed for the device master record.
Specify required machinery, fixtures, gauges, and other equipment needed for the verification and manufacture of medical devices.
Work with internal resources to obtain and plan for the installation of equipment in a clean environment. Create and execute Installation Qualification protocols and reports.
Design or aid in the design/modification of extrusion and molding processing tooling.
Train technicians and manufacturing associates on manufacturing processes in conjunction with the operations team through product launch and subsequent sustaining engineering actions.
Develop test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
Ensure developed processes meet or exceed the required cycle time to meet initial production forecast and cost. Create DOEs to characterize and improve processes.
Initiate improvements in new and existing processes to improve part quality/yields, cycle times, and to reduce cost, using LEAN manufacturing and Six Sigma skills.
Our expectations
Bachelor of Science in Mechanical, Manufacturing, Industrial Engineering. EIT or PE a plus.
Minimum 3 years of experience as a process, validation, or manufacturing engineer in a manufacturing environment.
Must possess a hands-on mechanical aptitude.
Strong interpersonal, oral, and written communication skills with the ability to effectively communicate within the organization, and with customers and suppliers as required.
Ability to provide accurate inputs for the preparation of project timelines and estimates.
Proficient with use of Microsoft Office applications including Word, Excel, Visio and PowerPoint. Proficient with use of SolidWorks 3D CAD software to create solid models and engineering drawings. Able to learn and use MRP systems; SAP preferred.
Ability to utilize metrology equipment such as pin gauges, calipers, micrometers. CMMs.
Ability to learn and use a variety of problem solving methods to find solutions to complex engineering problems, root cause analysis, fault-tree analysis, DMAIC, 8D, 5-whys.
Certifications in LEAN manufacturing, SPC, or Six Sigma technique a plus.
Ability to work with little supervision; to work in teams or independently.
Preferred Qualifications:
Medical manufacturing experience.
Experience in silicone, plastic, or rubber extrusion or molding manufacturing.
Experience in a structured regulatory environment with advanced quality systems such as ISO13485, FDA CFR 21, ISO 9001, AS9100, TS16949, or equivalent.
Experience with LEAN manufacturing.
Freudenberg Medical is a global leader in medical contract manufacturing; we offer the following services for medical device, pharmaceutical and IVD clients worldwide − product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.
For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms.
Location: Carpinteria, CA
We are currently hiring for a Manufacturing Engineer II who:
Will identify, develop, and qualify new manufacturing processes, fixturing, and tooling in preparation of transfer to manufacturing for commercial production
Enjoys working independently and in a team environment where quality in manufacturing is key.
Is detail oriented and motivated to learn quickly and provide support for existing production processes, initiate continuous improvement activities, and will implement, troubleshoot, and optimize setups to meet engineering and customer requirements.
Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.
Contact Person: Rachel Peterson
Company Name: Freudenberg Medical
Contact Email Address: rachel.peterson@freudenbergmedical.com
SENIOR QUALITY ENGINEER - ISO 13485
Job Description
Your tasks
The Sr. Quality Engineer will Represents Freudenberg Medical Quality System to FDA, Notified Body & customers
Close communication with customers, process engineering, operation, QC, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.
Shares technical expertise with others and helps develop junior level engineers.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data are insufficient or confirmation by testing is advisable.
Execution of both Internal and/or External supplier audits
Our expectations
BS in Engineering discipline (ME or Plastics);
At least 8 year’s experience in a Quality Engineering or Quality Assurance position in a Medical Device Company
Demonstrated experience with Quality System Tools (Control Plan, PFMEA, MSA, SPC, etc.) as well as GD&T and fixturing.
Demonstrated experience with formal problem-solving methodologies, critical thinking and deductive skills.
Working knowledge of design control requirements, testing and inspection equipment and techniques as they relate to their device responsibilities.
Technical knowledge in development methodologies, design and project implementation, including, but not limited to GD&T, and DOE.
Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
Knowledge of clean room requirements (testing, monitoring and controlling).
Proficiency in the use of PC and programs, particularly Excel and Word.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Able to prioritize and execute tasks in a timely manner with limited supervision.
Preferred Qualifications:
MS Degree
Experience with medical device contract manufacturing with silicone and extrusion experience.
American Society for Quality CQE (Certified Quality Engineer)
Freudenberg Medical is a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.
For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Freudenberg Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Costa Rica, Europe and Asia.
Location: Carpinteria, CA
We are currently hiring for a Senior Quality Engineer who:
Is responsible to support product quality by establishing quality standards, supporting and facilitating corrective action requests, implementing mistake proofing, developing workmanship standards, tracking and analyzing internal quality performance, and supporting quality system requirements.
Enjoys working independently and in a team environment where quality in manufacturing is key with a positive and can-do attitude to facilitate root cause analysis and implementation of corrective action for process related concerns.
Hands-on with a thirst for critical thinking and logical problem solving with an interest in quality and manufacturing.
Knowledgeable with MSA and Quality Tools such as Gage RnR, pFMEAs, test methods and statistical techniques.
Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.