Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
In this role you will use sound and proven engineering principles to assist in developing and implementing processes and requirements. Working as a member of a technology team, you will collaborate with other engineers, management, and operators.
This position will support current manufacturing and scale up new products from R&D. Involvement may begin from feasibility at vendors to full scale manufacturing.
Conducts and utilizes problem solving techniques to identify root causes to technical issues and develops and implements sustainable countermeasures to address them.
Takes a proactive approach to continuous improvement initiatives by analyzing existing processes and applying lean manufacturing techniques and concepts to improve production efficiencies, throughput, scalability, and quality.
Interacts with development personnel to ensure that processes and designs meet requirements.
Works cross-functionally to support production and development: CAPA, Exception Management, Risk Management, Yield, Capacity, and other Continuous Improvement
Functional Description: Technical Individual Contributor
Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products. Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality. Interacts with product design and development personnel to ensure that processes and designs are compatible.
Essential Duties & Responsibilities:
Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system.
Create and execute equipment qualification documents (IQ/OQ/PQ) and process validations.
Demonstrate hands-on process understanding and provide guidance and training with plant operators on engineering level builds.
Design and develop fixtures and equipment components required to meet process goals from concept to implementation.
Implement, characterize, and optimize processes, mechanical tests, and fixtures/jigs for assembly, inspection and test through implementation of measurement systems, part inspections, MSA, and capability analysis.
Assist in scaling up equipment and processes from prototype to pilot to full scale manufacturing. Provide design and assembly requirements working within scope as determined by business and schedule needs.
Perform statistically robust and industry standard analysis of data, and present findings to technical teams
Develops, validates and implements improvements to increase throughput and improve manufacturing yields.
Analyzes existing manufacturing processes and in-process tests. Streamlines production lines to reduce overall production costs.
Investigates field failures. Performs failure analysis and determines root cause. Designs and validates product enhancements to improve product reliability.
Independently manages and prioritizes projects, tracks progress toward overall goals, and provides periodic updates to management.
Assembles and analyzes pareto charts for yield failure modes and creates and drives action plans to address yield loss.
Applies lean manufacturing techniques and concepts to assembly line processes to improve efficiencies, throughput and quality.
Reviews and evaluates capacity models and anticipates when new equipment or additional headcount will be required.
Demonstrates initiative by seeking out new projects that can positively impact the organization by reducing scrap, increasing gross margins and improving productivity.
Analyzes and plans work force utilization, space requirements, and work flow. Designs layouts to place new equipment and workspace for maximum efficiency.
Develops test plans, DOEs and validation IQ/OQ/PQ protocols. Executes protocols and writes reports to ensure equipment/processes meet assembly specifications and regulatory requirements.
Conducts yield analysis such as Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality
Reviews assembly process instructions and makes updates to improve repeatability and standard work.
Typically requires a B.S. in Mechanical Engineering, Bioengineering, Materials Science or equivalent with 0-2 years related experience or an M.S. in Mechanical Engineering, Bioengineering or equivalent with 0-1 year related experience. (Medical Device/Biotech experience desired)
Ability to run self-directed projects, maintain timelines, stay organized, and balance multiple activities in a fast-paced environment
Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
Proven ability to work hands-on in a fast-paced environment.
Familiar with experimental design, data analysis, and interpretation of experiments.
Excellent communication (written and verbal) and personal interaction skills
Medical device experience
JMP or Minitab experience
Proficient in the use of SolidWorks or equivalent CAD software.
Lean Six Sigma or Six Sigma DMAIC methodology
Manufacturing or sustaining experience
Experience with semi-automated and automated manufacturing equipment
Experience in DFA/DFM
Experience and Education Requirements:
Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 0-2 years related experience.
Up to 25%
Applies basic technical understanding with the knowledge to develop process and design experiments. Possesses theoretical knowledge, but is learning the industry and requirements of applied science. Understands organizational and functional processes and policies.
Demonstrates potential for technical proficiency. Works on problems of basic scope in which analysis of situation or data requires a review of data factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Normally receives instructions on all work and work output it supervised.
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 firstname.lastname@example.org.
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.