Process Development Engineer

(none selected) | Direct Hire

Post Date: 03/29/2017 Industry: Software/Hardware

SUMMARY:

Sr. Process Development Engineer will be a key member of the Operations team to develop and transfer improved processes (“faster, cheaper, stronger”) for manufacturing existing products.  Scope of work includes all device assembly processes such as scanning, bonding, curing, soldering, plasma treatment, molding, coating, and inspection.  Processes need to be lean and scalable, typically automated or semi-automated in nature, for manufacturing individually customized products.  Additionally, the individual will perform occasional production support and serve as a technical interface with key suppliers.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned as necessary):

• Characterizing existing processes and defining process requirements

• Perform proof-of-process and demonstrate it meets defined goals

• Perform in-depth process development / statistical analysis. 

• Independently design experiments, develop protocols, perform process validations and data analysis, draw conclusions and communicate results.

• Establish process flow and production line layouts 

• Work with Equipment Development to design/select process equipment and/or equipment vendors

• Present technical reviews of projects to cross-function teams

• Train assemblers, technicians, and engineers on new processes

• Support Manufacturing, R&D, and outsourcing projects as needed

• Occasional travel, as needed, to work with equipment and component suppliers

 

QUALIFICATIONS:

• Hands-on individual with demonstrated process development experience

• Project management/supervision experience

• Experience using Solidworks to model/design equipment and fixtures. 

• Ability to solve problems using structured methods. Experience breaking down high level process requirement into addressable action items.

• Attention to detail in process characterization and documentation. 

• Ability to work in a team environment - strong communication and negotiation skills.

• Have a strong understanding and experience performing medical device process validations.

• Ability to identify critical process parameters and apply statistics to process measurement and control

• Firm understanding of lean manufacturing techniques.

 

EDUCATION and/or EXPERIENCE:

• Requires Bachelor’s degree in engineering or related field 

• 5+ years of experience in a medical device manufacturing environment.

• Proven project management skills

 

Please note that this position may have exposure to blood borne pathogens. Earlens will comply with Cal-OSHA requirements and will provide vaccination, communication, and training of its Exposure Control Plan.


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