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Staff Manufacturing Engineer (relocation assistance offered)

Company: Endologix, Inc.
Location: Santa Rosa
Posted on: November 9, 2019

Job Description:

*

STAFF MANUFACTURING ENGINEER (RELOCATION ASSISTANCE OFFERED)

Job ID

2019-2136

Location

US-CA-Santa Rosa

Category

Operations

OVERVIEW

Maintain existing manufacturing processes and equipment to support output goals and product quality requirements through line support, dispositioning non-conforming material, and driving investigation and completion of CAPA.

Evaluate, prioritize, and improve manufacturing processes to achieve cost of goods sold, product quality and cycle time targets. Collaborate with R&D, Quality Engineering and manufacturing team members to implement improvements.

Help to design and develop manufacturing processes and tooling for new products from process conception through qualification. Collaborate with the R&D organization to help facilitate the successful execution of the New Product Development Process and launching products.

RESPONSIBILITIES

* Drive improvements and changes through the DCO, NCR and CAPA processes as a reviewer for Manufacturing Engineering and/or as primary owner.

* Lead efforts in designing and developing manufacturing processes and equipment for product changes to ensure enhancements improve quality, yields, cycle time, throughput or efficiency.

* Collaborate with product development team to ensure that products under development are consistent with Design for Manufacturability principles and to resolve manufacturing issues.

* Lead work team meetings to ensure plans and schedules are on time and aligned with business objectives. Report progress, risks and needs to leadership.

* Support manufacturing lines by providing technical expertise to resolve assembly, product quality and documentation issues.

* Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Engineering functions.

* Actively participate on product development projects as Manufacturing Engineering member supporting creation and review of all required project documentation (e.g. Risk documentation, testing reports, etc.)

* Develop and execute process validation protocols and appropriately document results in reports (IQ/OQ/PQ).

* Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc.

* Identify hazards and mitigate risk associated with identified hazards in Process FMEA.

* Support company goals and objectives, policies and procedures, and FDA regulations.

Additional Duties:

* Apply Lean and Six-Sigma principles to implement improvements to manufacturing and business processes.

* Apply statistical methods to estimate future manufacturing requirements.

* Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance.

* Ensure that all regulatory and internal policies are followed.

* Maintain accurate documentation of concepts, designs, processes, and equipment.

* Assist engineering manager in development of engineers providing assistance with coaching and mentoring.

* May lead and sometimes supervise small professional staff / resources for projects

* Perform other duties as assigned by supervisor.

QUALIFICATIONS

* Works on multiple complex problems in which analysis of situations requires improvements of processes to increase product performance

* Works under limited supervision and exercises good judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.

* Has the ability to use statistic techniques when analyzing data and make rational and logical decision based on that analysis

* Working knowledge and history of application of Lean and Six-Sigma principles.

* Applicable knowledge of Minitab, JMP, or other statistic tools

* Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)

* Ability to handle multiple tasks simultaneously and ability to manage project timelines

Education:

* Bachelor's degree in from a four-year college or university; or related major preferred; Masters of Science (MS) degree in or Master s degree related to preferred; PhD degree in ; or equivalent combination of education and experience

* Bachelor's degree in Mechanical Engineering, Bioengineering from a four-year college or university; or related major in Life Sciences preferred

Experience:

* Eight years with a Bachelor s degree, Six years with a Master s degree, Three years with a PhD, of directly relevant experience in pharmaceutical, medical related industry or field. Experience with design of experiments, protocol creation, statistics, and unique technologies are desired. Experience with polymer development and characterization is preferred.

* Eight years with a Bachelor s degree, Six years with a Master s degree, Three years with a PhD, in medical device manufacturing, development, testing, or designing, GMP, FDA, and ISO requirements and experience writing protocols, test plans, test reports, design control regulation and experience with catheter and stents preferred.



*Relocation Offered

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Endologix, Inc., Santa Rosa , Staff Manufacturing Engineer (relocation assistance offered), Engineering , Santa Rosa, California

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