Staff Manufacturing Engineer at Dexcom in San Diego, California

Job Description:

About Dexcom:

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:
The Staff Manufacturing Engineer Possesses a high level of theoretical knowledge. Ability to deliver technical ideas that have an impact on the objectives. Understands organizational and functional processes and policies aligned to the technical and business goals, with concentration on product transfer and direct line support (new product development and technical transfer to a sustaining manufacturing environment.)

The personnel in this position will need to demonstrate technical proficiency. Works on complex problems where analysis of situations or data requires evaluation. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Interprets data and draws conclusions regarding results used in presented material. Personnel in this role must be systematic, highly organized, and articulate within a cross-functional team environment. A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Functional Description: Technical Individual Contributors

Develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations.

Functional/Business Knowledge:

• Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.

Scope:

• Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in‐depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.

Judgement:

• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.


• Determines methods and procedures on new assignments and may coordinate activities of other colleagues.

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

• The Workplace Type for this role is Flex. Based on the nature of your position you will be working onsite approximately 2-3 days per week from collaborative space and hoteling desks at our Dexcom sites. You will need to be located within commuting distance (typically 75 miles/120km) of your assigned Dexcom site.

Essential Duties and Responsibilities:

• Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system.


• Demonstrate hands-on process understanding and provide guidance and training with plant operators on engineering level builds.


• Develop and maintain project timelines and provide updates and feedback to project leadership.


• Design and develop fixtures and equipment components required to meet process goals from concept to implementation.

• Create and release material and equipment specifications and drawings, establish calibration and preventative maintenance requirements.


• Confer with vendors to produce equipment, materials, and/or parts that meet determined product specifications.


• 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. Applies lean manufacturing techniques and concepts to assembly line processes to improve efficiencies, throughput and quality.


• 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. Assembles and analyzed pareto charts for yield failure modes. 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.


• Demonstrates initiative by seeking out new projects that can positively impact the organization by reducing scrap, increasing gross margins and improving productivity.


• 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.

Required Qualifications:

• STEM degree from accredited College/University.


• At least 10 years of hands-on experience with high volume manufacturing and equipment development for assembly and automation systems. Medical device or regulated industry experience preferred.

• Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)


• Excellent communication (written and verbal) and personal interaction skills. Able to organize and prioritize assignments providing direction to and participation in assigned functional teams.


• Technical writing skills as applied to manufacturing documentation and process development - Experienced in the creation and revision of technical documentation.


• Strong background in product design lifecycle and overall product technical transfer to manufacturing.


• 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 with competing priorities.


• Excellent communication (written and verbal) and personal interaction skills.


• Eagerness to share, or tryout new ideas, perspectives, or solutions.


• Awareness to assist fellow engineers, operators, and technicians complete their activities when opportunities arises.


• Detailed oriented with strong time management skills.

Preferred Qualifications:

• Familiar with experimental design, data analysis, and interpretation of experiments; JMP experience preferred.


• Manufacturing or sustaining experience.


• Knowledge of continuous integration and deployment.

• Ability to work with many different software development teams to develop, test, deploy and report on product performance, quality, security and stability.


• Use your knowledge and specialized skills to implement technical solutions and provide high quality support.


• Interact with management and staff to provide analytical and technical assistance for continuous improvement.


• Manage and lead technical projects.


• Identify root-causes of operational issues and process inefficiencies.

Travel Required:

• Up to 25%

Language Skills: Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 100 lbs.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high - precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.

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 Dexcom Talent Acquisition at talentacquisition@dexcom.com.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.