Senior Engineer - Process Development Manufacturing

5 - 7 years experience  • 

Salary depends on experience
Posted on 02/23/18
San Diego, CA
5 - 7 years experience
Salary depends on experience
Posted on 02/23/18

Summary:

In this role, the Engineer will use engineering principles to assist in developing processes and process requirements from internal and external stakeholders.  Process development activities will focus on Dexcom’s sensor wire technology. Working as a member of a technology team, this engineer will collaborate and communicate with other engineers, management, and operators. This position will lead efforts to understand current and future needs of manufacturing and automation processes, explore and evaluate new technologies and concepts for meeting those needs, and rapidly demonstrate feasibility of such technologies through rigorous modeling, analysis, prototyping, experimentation, and otherrisk identification and mitigation activities. The position will transfer and work on process development/scale up of new products from R&D. Involvement may begin from feasibility at vendors to full scale manufacturing.

 

Essential Duties and Responsibilities:

  • Lead/advise in process development, product transfer, and process improvement projects to improve product quality, decrease cost, and improve manufacturing efficiencies
  • Resolve complex process/product development and manufacturing issues independently and/or take lead of working cross functional teams
  • Confers with vendors, management, engineering, and other staff to determine product specifications and capabilities
  • Plans and performs Design of Experiments (DOE) to characterize and determine optimal processing methods
  • Facilitate in design control and take lead in developing, writing and releasing manufacturing documentation
  • Demonstrate hands-on technical understanding and provide guidance and training to junior engineers and technicians on test methods and data analysis techniques
  • Participate in risk identification and product specification definition activities as a member of a cross functional team
  • Provide technical assistance in scaling up equipment and processes from prototype to pilot to full scale manufacturing
  • Perform statistically robust and industry standard analysis of data, and present findings to technical teams
  • Provide build plans, scheduling requirements and coordinate product development builds within a pilot production facility for multiple projects and project teams 
  • Identify process risks and track mitigations through standard methods
  • Exercise judgment within defined procedures and policies to determine appropriate action.
  • This position assumes and performs other duties as assigned

 

Required Qualifications:

  • Proven track record to run self-directed projects, maintain timelines, and execute in a fast-paced environment
  • Knowledge of high reliability, high volume manufacturing processes and designs
  • Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
  • Previous direct involvement in regulated medical device industry process development
  • Proficiency in the use of SolidWorks or equivalent CAD software
  • Strong proficiency with data analysis methods and JMP or equivalent statistical software
  • Demonstrated competency in experimental design, execution, and interpretation of data
  • Detail oriented with strong time management skills
  • Excellent communication (written and verbal) and personal interaction skills

 

Preferred Qualifications:

  • Leansix sigmagreen belt
  • MSA/GRR, IQ/OQ/PQ, and SPC experience

 

Education Requirements:

  • B.S. in Mechanical Engineering, Bioengineering or equivalent.
  • 5+ years related experience

25843

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