Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
Summary:
This role is in the Ops Advanced Manufacturing Engineering team as a Controls Engineer to provide engineering support for moderate to complex high-speed automated equipment which are primarily used in Contract Manufacturers' clean room facilities. Support includes equipment sustaining and process improvement activities for existing equipment, as well as preparation of specification, planning, designing, programming, testing, installation and GMP validation of new or upgraded equipment. The goals include meeting all corporate goals and quality commitments goals. This position provides opportunity to develop professionally, work on new projects, and assume increasing levels of responsibility. This is a hands-on role which requires specific skillsets and experience in understanding how to apply hardware engineering concepts for Production use.
Provides expertise in engineering, design, installation and start-up of automation systems. Actively assists manufacturing operations in problem solving with regards to the automated systems. Assists in the validation of process and facility automation. May also develop code and design system architectures in order to define user compatibility.
Essential Duties and Responsibilities:
Perform automation, instrumentation and controls engineering services for existing and new equipment installed within Dexcom's contract manufacturing facilities. Scope of work includes activities from design through installation, testing and qualification of equipment. Projects may include new equipment, existing equipment upgrades, capacity expansions, equipment replacement as well troubleshooting existing issues in order to improve productivity and quality.
Create and/or review design specifications, drawings, and other project documents such as URS, FNS, SDS, etc.
Develop and execute test plans, and controls related validation protocols. Write reports to ensure equipment/processes meet part/assembly specifications and regulatory requirements.
Review and approve vendor provided document package including but not limited to drawings, manuals and validation protocols as they relate to equipment controls systems.
Perform PLC /HMI/PC/vision code review and approval. Recommend and/or implement improvements to enhance performance and reliability.
Proficient in writing new code or modifying existing PLC/HMI/PC/Vision software to enhance or expand functionality, and reliability. Experience with Allen Bradley PLCs and Cognex vision products is highly desirable.
Proficient in writing new or modifying existing data collection software using commercially available data collection and SCADA/HMI packages such as Ignition, Wonderware, and FactoryTalk. Experienced in using connectivity platform such as Kepware
Working knowledge of different types servos systems, sensors and devices is required
Manage assigned project to ensure projects are completed on-time and within budget
Hands on investigation and troubleshooting of manufacturing equipment issues is required
Experience in perform Engineering Studies using DMAIC methodology is highly desired
Provide training and coaching to engineers and technicians on new and existing procedures
Proficiency in using Project engineering tools such as Microsoft project, statistical programs and Microsoft office is required
Ability to effectively collaborate and communicate with company interdepartmental teams including Regulatory, Quality Assurance, R&D and Process Engineering is required.
Assure all manufacturing processes efforts adhere to regulatory and quality requirements
This position assumes and performs other duties as assigned
Required Qualifications:
3+ years' experience developing PLC/HMI programs for high speed automated equipment is required.
5+ years knowledge of equipment validation (URS, FAT, SAT, IQ, OQ & PQ)
Experience with automated systems in a Product Test Engineering environment
Experience in installation and validation of automated equipment
Working knowledge of GMP standards and procedures
Demonstrated use of analytical tools and procedures used in Lean Six Sigma such as utilizing the DMAIC methodology for continuous improvement
Demonstrated experience in medical device automation, test methods/standards, processes and related equipment
Proficient in using PC/Software including Microsoft Office, Microsoft Project, statistical tools and CAD software
Experience in working in clean room environments
Basic knowledge related to product, process, and equipment used in a medical manufacturing environment
Ability to work in Team environment across multiple functional groups
Ability to handle multiple concurrent projects and conflicting priorities
Proficient in computer skills and use of Microsoft Office (Word, PowerPoint, Excel)
Excellent team-oriented communication and organizational skills
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily, be detail oriented, and interested in or fluent in quality systems. Additionally, the requirements listed below are representative of the knowledge, skill, and/or ability required
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Preferred Qualifications:
High levels of expertise in PLC environment in development role
Experience as a developer for Cognex vision system is highly desired
Experience developing and deploying multi axis robots into a high-volume manufacturing environment is highly desired
Experience with V&V of Automated systems on the factory floor
Strong familiarity with electro-mechanical equipment design and development process
Excellent communication (written and verbal) and personal interaction skills
Proven ability to work hands-on in a fast-paced environment
Proven ability to multi-task, prioritize projects, and maintain timelines
Flexibility in a changing environment
Detail oriented and organized
Experience and Education Requirements:
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
Functional/Business Knowledge:
Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
Scope:
Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in‐depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Judgement:
Exercises good judgment in selecting methods and techniques for obtaining solutions.
Normally receives little instruction on day‐to‐day work, general instructions on new assignments.
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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.