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.
Provide Operations engineering support for moderate to complex equipment in manufacturing areas including clean room environment. This position is for an altered workweek from Thursday thru Monday each week and shifted work hours from 10am-7:00pm each day. Equipment production support, process improvement, implementation and GMP validation assignments and projects are all part of this engineering role. Candidate must have sustaining Automation experience as well as production support of manual operations. Engineering and Operations activities may include planning, developing, designing, troubleshooting, installation and/or any other aspect of Engineering or Operations work.
Functional Description: Technical Individual Contributor
Designs and analyzes mechanical systems, equipment and packaging. Conducts feasibility studies and testing on new and modified designs. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Provides design information to drafting for packaging documentation.
Essential Duties and Responsibilities:
Provide production support for off week and shifted work hours
Direct production support for all manufacturing area during adjusted work schedule
Designs, improves and implements production equipment/processes, fixtures/jigs for production equipment and assembly to improve product quality, increase productivity or reduce costs. Use Solidworks to create models and drawings for equipment designs.
Hands on investigation and troubleshoot manufacturing issues. Perform Engineering Studies using DMAIC methodology.
Collaborates and communicates with company interdepartmental groups including Regulatory, Quality Assurance, R&D and Process Engineering providing documentation and operational support of equipment issues.
Perform validation IQ/OQ/PQ protocols, test protocols. Write reports to ensure equipment/processes meet part/assembly specifications and regulatory requirements.
Provide training and coaching to engineers and technicians on new and existing procedures
Project engineering using Microsoft Office, statistical programs and Microsoft Project.
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.
Ability and Desire to work an altered workweek providing on-site support over weekends.
Demonstrated experience in medical device automation, test methods/standards, processes and related 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.
Working knowledge of equipment validation (URS, FAT, SAT, IQ, OQ & PQ)
Demonstrated engineering production support of automated equipment
Perform Mechanical tooling and fixture design to implementation project capability.
Strong use of PC/Software including Microsoft Office, Microsoft Project, statistical tools and Solidworks.
Experience in working in clean room environments.
Strong mechanical equipment development background
Proven ability to work hands-on in a fast-paced environment. Demonstrated production engineering support
Proven ability to multi-task, prioritize projects, and maintain timelines.
Flexibility in a changing environment.
Working knowledge of using machine vision for inspection.
Working knowledge of PLC and HMI code
Semi-Automation or automation experience is preferred.
Excellent communication (written and verbal) and personal interaction skills.
Detail oriented and organized
Possesses broad understanding of technical principles and theories.
Ability to synthesize external data and research findings for application that may impact technical objectives.
Demonstrates successes in technical proficiency and independent thought.
Works on complex problems in which analysis of situations or data requires an indepth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
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.
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 25 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, fumes or airborne particles, toxic or caustic chemicals, risk of electric shock, The noise level in this work environment can range from quiet to moderate 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 firstname.lastname@example.org.
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