Sr Process Development Engineer at Dexcom

Posted in General Business 18 days ago.

Type: Full-Time
Location: 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:

Develops and modifies manufacturing equipment requirements and specifications, and reviews processing techniques for manufacture of new products and to decrease cost, improve process yield, improve throughput, and improve overall quality for commercial product lines. Will team with suppliers and global contract manufacturers to manufacture sub-assemblies for product builds at Dexcom sites to include San Diego, CA and Mesa, AZ manufacturing sites. Provide manufacturing support to contract manufacturers and suppliers to identify and resolve complex technical issues. This Senior Engineer position will be highly involved with 2 or more of the following: 1) PCBA electronics 2) Mechanical sub-assemblies, and 3) single use Sensor Applicator devices.

Functional Description: Technical Individual Contributors

Develops new or modified process formulations, defines processing or handling equipment requirements and specifications, and reviews processing techniques and methods applied in the manufacture, fabrication, and evaluation of products. Involvement may begin at any step from pilot plant to full-scale manufacturing. Coordinates design requirement review with appropriate engineering/scientific personnel to ensure compatibility of processing methods. Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications. May conceive and plan projects involving definition and selection of new concepts, equipment automation technology, and approaches in the processing or development of new or improved processes.

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.

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.

Essential Duties and Responsibilities:


  • Participates in process development and process improvement projects to improve product quality, decrease cost with alternate materials / parts, and improve manufacturing efficiencies.

  • Participates with internal teams, suppliers, and contract manufacturers in the development oftest plans, validation IQ/OQ/PQ protocols, and test protocols. Participates in the execution of protocols and write reports to ensure equipment/processes meet part/assembly meet requirements.

  • Applies statistical methods to estimate future manufacturing requirements, production and field performance data to identify issues and opportunities for improvements.

  • Develops and maintains project timelines and provides updates and feedback to project leadership.

  • Accomplishes tasks while conforming to the company quality system procedures.

  • This position assumes and performs other duties as assigned.

Required Qualifications:


  • Detail oriented with strong time management skills

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

Preferred Qualifications:

  • Proven track record in the commercialization and manufacture of medical devices and/or medical diagnostic products preferred.

  • Master's degree preferred in Chemical Engineering, Bioengineering, Mechanical Engineering or related field.

  • MSA/GRR, IQ/OQ/PQ

  • Familiarity with Good Manufacturing Practices (GMP).

  • Competent in design, execution, data analysis, and interpretation of experiments.

  • Equipment Qualification (IQ,OQ,PQ) experience

  • High throughput automation experience

  • Equipment Maintenance/Mechanical knowledge

  • Working knowledge of Good Manufacturing Practices (GMP).

  • Calibration knowledge and understanding

  • Vision System experience

  • Process Development experience

  • Knowledge of Lean and Six Sigma methods

  • Knowledge of Statistical Process Control Methods

  • Knowledge of two or more areas of experience listed below:

    • PCBA manufacturing

    • Mold tooling development

    • Injection molding and liquid silicone rubber over molding processes

    • Chemical processes for epoxies (2 part type and UV cure type).

    • Sterile Barrier Packaging




Travel Required:
  • 0 - 24%

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.

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.