Manager, Manufacturing Engineering
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POST DATE 8/12/2016
END DATE 10/11/2016
Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.
Directs the engineering support of manufacturing operations, cost reduction and scale-up of processes.
Directs the design and scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing scale.
* Supervises the Manufacturing Engineering team consisting of Engineers and Technicians.
* Manages the development, implementation and maintenance of processes and equipment for manufacturing of products to achieve cost effectiveness and product quality.
* Support Lean education and implementation initiatives .
* Works with product development teams to ensure design for manufacturability.
* Design and develop manufacturing processes for new products and/or changes to existing products
* Design and develop fixtures and tooling for manufacturing process
* Develop and execute process validation protocols (IQ/OQ/PQ)
* Analyze process data and make decisions/recommendations relating to process capability and DFM
* Contribute to the intellectual property position of the company via invention and patent applications
* Maintain accurate documentation of concepts, designs, and processes.
* Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
* Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
* Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
* Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
* Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
* Ensure that all regulatory and internal policies are followed
* Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
* Perform other duties as assigned by supervisor.
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
* Has the ability to use basic to moderate statistic techniques when analyzing data and make rational and logical decision base the that analysis
* Applicable knowledge of Minitab, JMP, or other statistic tools
* Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
* Manages engineering staff and projects of diverse scope in which analysis of data requires evaluation of identifiable factors.
* Requires a Bachelor of Science degree in Engineering or related technical degree (i.e. physics or mathematics)
* Masters degree preferred
* Ten years with a Bachelor s degree, Eight years with a Master s degree, Five 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.
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.