Advanced Manufacturing Engineer Jobs Vacancy in Bard Tempe
Bard Tempe urgently required following position for Advanced Manufacturing Engineer. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.
Advanced Manufacturing Engineer Jobs Vacancy in Bard Tempe Jobs Details:
Essential Job Functions
- Working as an integral member of pilot operations teams, developing manufacturing processes and transferring those processes into manufacturing.
- Be the development team expert in lean manufacturing and design for manufacturability.
- Analyzes problems in design, process and test development. Recommend/implement solutions.
- Develops and manages validation studies (IQ, OQ, PQ and test methods) on equipment & processes.
- Writes and approves protocols, reports, manufacturing procedures, test procedures and other documentation and tracks through appropriate approval cycles and implementation.
- Maintains a professional working relationship with internal and external customers and support staff.
- Participates in cross-functional teams.
- Provides technical support on components, material methods, systems and equipment.
- Manages test builds and testing outlined in protocols and test methods.
- Understands and follows company procedures and regulatory requirements.
- Participates in and provides input to training on department & division procedures, and policies.
- Manages, prepares and reports on project planning, budgeting, scheduling and tracking.
- Experience in the manufacture of implantable medical devices
- Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
- Design capability with small plastic and metal parts
- Ability to read and understand mechanical drawings
- Working knowledge of materials typically used in medical devices
- Significant experience in product verification and validation testing, medical device new product development and rapid prototyping
- Experience in product verification via test equipment development and process validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage)
- Proficient in technical writing of protocols and reports
- Proven capability in writing clear and detailed testing and product assembly procedures
- Impeccable documentation skills and adherence to design control procedures and GLP
- Demonstrated experience in application of lean manufacturing principles
- Comfortable in a dynamic working environment with a high amount of change
- Demonstrated ability in using statistical analysis techniques (i.e. Capability Analysis)
- Familiarity with solid modeling (i.e. Solidworks)
- Ability to make and present engineering decisions
Responsible for generating equipment AFE’s and working within a budget
- New product manufacturing process development experience a must
- Experience with transferring medical product design and processes from development into large scale manufacturing
- Lean six sigma black belt desired
Education and/or Experience
- Bachelors degree in science or engineering and a minimum of six (6) years experience within the medical device industry, or a Master’s degree and a minimum of five (5) years of engineering experience within the medical device or equivalent industry.