Manufacturing Engineer Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Establishes and improves manufacturing processes and work environment to improve production efficiency.
Reports To: Director of Operations Engineering
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Improve production line efficiency, flexibility, and work environment to improve yield, capacity, and product quality.
Serve as the first engineering contact when issues are encountered on the production floor. Correct tooling, equipment, and process issues, and raise larger issues to the broader Operations Engineering group when help is needed.
Work with Production and Materials groups to address BOM issues, in order to facilitate accurate and efficient back-flushing and inventory management.
Set up necessary carts and bins to facilitate proper materials management on the production floor.
Perform time studies, when needed, to assess line capacity and to identify areas to improve.
Execute plans to expand the production line, and to add new products in a manner that optimizes floor space.
Ensure production line tooling and fixtures are functioning properly.
Lead projects to introduce new products to the production line and to improve existing tooling, fixtures, and procedures.
Document and update work instructions, as needed to maintain and improve the production line.
Assume ownership of production yields, improving them to meet goals.
Perform investigations to FARs, NCMRs, and line issues, and document findings accordingly.
Create charts to track and communicate progress.
Lead and/or participate on project teams to design, develop, and continuously improve product, equipment, fixtures, and/or processes.
Perform engineering work typically including one or more of the following:
Process development including IQ/OQ/PQ
Process improvements including Validation & Verification
Product design for manufacturability, testability and serviceability
Production line layout & facility requirements
Provide training for line personnel, particularly on new processes and process improvements
Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies
Experience, Education, Training, Traits:
Bachelors degree in mechanical, electrical, chemical, materials or industrial engineering plus a minimum of 5 years of engineering experience in a manufacturing environment with a minimum of 2 years experience in an FDA regulated manufacturing environment or an equivalent combination of education and experience to perform at this level.
Some level of programming or scripting is preferred.
Proficiency with medical device development life cycles and manufacturing processes and technologies.
SAP experience is desirable.
Ability to focus on and achieve scheduled milestones, including contingency planning.
Knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing is preferred.
Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. Pro-E competency is desirable.
Language and Verbal Skills
Good oral and written communication skills.
Ability to write reports, specifications, and business correspondence.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to use MS Excel to perform calculations and interpret results/data.
||Pleasanton, CA |
THIS JOB HAS EXPIRED