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.
The Mechanical Engineer is for an engineer to take equipment developed by automation integrators and move it into Dexcom's Commercial Operations. The candidate will need to be skilled in use of robotics, vision, sensors, PLCs and integration of equipment technologies. The candidate should have experience operating and testing automation. Additionally, the position requires writing Factory Acceptance Tests and Validation protocols in an FDA environment. This is not an automation equipment design position, it is commissioning and sustaining position.
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 & Responsibilities:
Plan, design, develop and execute operating and validation protocols to perform factory buyoffs of moderate to complex automation and execute installation and operation qualifications.
Develop, implement and support changes, perform re-qualifications of Automated machines and procedures.
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 to maintain equipment in prime operational control.
Develop validation IQ/OQ/PQ protocols, test protocols. Execute protocols and 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 equipment and procedures.
Project engineering using Microsoft Project, statistical programs and Microsoft Office.
Collaborates and communicates with company interdepartmental groups including Regulatory, Quality Assurance, R&D and Process Engineering.
Previous experience with providing engineering to develop and operate multiple technologies and sensor types on automated equipment. Application use of PLCs a must
Strong use of PC/Software including Microsoft Office, Microsoft Project, statistical tools and Solidworks.
Demonstrated use of analytical tools and procedures used in Lean Six Sigma such as utilizing the DMAIC methodology for continuous improvement.
Perform Mechanical tooling and fixture design for equipment improvements.
Working knowledge of GMP standards and procedures
Experience in working in clean room environments.
Demonstrated experience in medical device automation, test methods/standards, processes and related equipment.
Working knowledge of equipment validation (URS, FAT, SAT, IQ, OQ & PQ)
Demonstrated project engineering on the commissioning of Automated systems on the factory floor.
Working knowledge of using machine vision for inspection.
Working knowledge of PLC and HMI code
Strong mechanical equipment development background
Excellent communication (written and verbal) and personal interaction skills.
Proven ability to work hands-on in a fast-paced environment.
Proven ability to multi-task, prioritize projects, and maintain timelines.
Flexibility in a changing environment.
Detail oriented and organized.
Semi-Automation or automation experience is preferred.
Bachelor's degree (BS) in Mechanical, Electrical Engineering, Bioengineering, or related field from four-year college or university and 3+ years of relevant industry experience and/or training.
Experience and Education Requirements:
Exercises judgment within defined procedures and practices to determine appropriate action.
Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
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 email@example.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.