Sr Process Development Engineer at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Mar, 26

Salary

152300.0

Posted On

01 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Manufacturing Processes, Root Cause Analysis, Statistical Analysis, Design For Manufacturing, Measurement System Analysis, Test Method Validation, Mentoring, Documentation, Project Management, Quality Systems, Cross-Functional Collaboration, Communication, Problem Solving, Six Sigma, FDA QSR

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Join a dynamic and collaborative multi-disciplined engineering team at Dexcom. We support the organization by standing up pilot manufacturing lines for new product development. These manufacturing lines are intended to prototype, evaluate and validate product designs. This role is crucial to develop the software systems which capture, store and view the data which is produced from the manufacturing line. Where you come in: Design, document and optimize new manufacturing processes for new stations, equipment, and processes within a regulated quality system Utilize process engineering characterization tools including DOE, p-diagrams, risk mitigation (pFMEA), process capability, and six sigma methodologies. Strong root cause analysis skillsets to troubleshoot processes, equipment or product design utilizing tools such as 5-Whys, Fishbone Diagram, Fault Tree Analysis, Is/Is-Not Analysis. Analyze data using statistical tools (JMP or Minitab) to evaluate process/product performance such as DOE, CpK, hypothesis testing, and optimizing processes with modeling Apply Design for Manufacturing/Assembly (DFM/DFA) principles to optimize product designs for cost, ease of assembly and robust manufacturing processes ensuring scalability. Develop test methods through Measurement System Analysis (MSA) methodology to assess and improve measurement reliability. Includes Test Method Validation (TMV) including protocol development, execution, and reporting. Experience with mentoring junior engineers and foster culture of innovation, accountability and technical excellence. Author and maintain validation documentation including protocols, reports, and risk assessments. What makes you successful: You bring proven experience in medical device or high-tech manufacturing, with a proven track record of launching complex products into high-volume production. Excellent knowledge of process characterization and experience with a variety of assembly methods You understand the full product lifecycle - from concept to commercialization - and navigate quality systems and frameworks including FDA QSR, ISO 13485, ISO 14971 and EU MDR. Listen and consider a variety of perspectives from cross-functional teams, including R&D, Quality, Operations and Regulatory to meet project goals. You communicate with clarity and executive presence, translating technical insights into actionable strategies for diverse stakeholders. Experience with project management tools such as JIRA, Confluence, Smartsheet What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 0-5% 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 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. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 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. 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. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true 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. Salary: $91,400.00 - $152,300.00

Responsibilities

Design and optimize new manufacturing processes within a regulated quality system. Develop software systems to capture and analyze data from pilot manufacturing lines for new product development.