24 days old

Senior Mechanical Engineer - Automation

Dexcom
San Diego, CA 92101
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  • Job Code
    33718
  • Jobs Rated
    57th

About Dexcom:

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.

Summary:

Under the direction of the Operations Engineering Manager, the Senior Mechanical Engineer provides technical support for the projects, functions, and strategic objectives of the Operations Equipment Group and department, concentrating on: engineering support for new product development; development of fixtures and equipment as standalone and in support of automated systems; failure mode analysis and corrective action of process equipment and instruments; sustaining engineering for the legacy and newly deployed manufacturing systems; engineering and quality documentation development.

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.

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.

Essential Duties and Responsibilities:

Automation Mechanical Engineering focusing on the below activities:

  • Design, develop, implement, maintain production level standalone fixtures as well as fixtures for use on production / automation equipment.
  • Develop proof of concepts to challenge / test automation assembly methods. Requires design and hands-on experience with high volume automation assembly machines.
  • Travel to automation vendors and contract partners to troubleshoot and test sustaining and new automation equipment.
  • Design, develop, and implement scalable processes, mechanical tests, fixtures/jigs for inspection, and methods/processes to improve product quality and increase productivity or reduce costs.
  • Perform tolerance stack analyses and create drawing specifications using GD&T, as appropriate.
  • Define and contribute to the development of product assembly equipment, system architecture, robotics concepts, and tooling with internal and external development teams.
  • Develop test plans, equipment requirements, protocols, and reports to ensure designs meet product and part specifications, regulatory requirements, and applicable standards for new equipment and processes including IQ/OQ/PQ protocols
  • Hands-on testing and development to support automation equipment prototypes, current/new processes, and various production issues.
  • Collaborate with R&D to integrate manufacturing principles (DFM/DFA) for new products.
  • Support vendor controls engineers with changes to sustaining and new automation equipment.

Other responsibilities:

  • Develops and maintains project timelines while providing updates and feedback to project leadership.
  • Collaborates with cross functional teams and manage vendors and contractors as per the project scope including qualifications of components and product. Duties include providing technical guidance, communicating design and manufacturing intent, validation activities, as well as some project management level tasks.
  • Plan, design, develop, and execute production cost and/or quality improvement projects including all necessary documentation.
  • Actively contributes during technical design reviews.
  • Effectively communicates with broad Dexcom team on project progress and challenges.
  • Accomplishes tasks while conforming to the company quality system procedures.
  • This position assumes and performs other duties as assigned.

Additional duties would typically include:

  • Ability to apply engineering design and drafting tools, such as SolidWorks.
  • Analyze field and/or manufacturing failures of mechanical components, sub-assemblies, and instruments, and provide corrective and preventative solutions and actions.
  • Participate as the Operations Mechanical/Systems Engineering representative in departmental and external project teams. Provide engineering support to assembly and test personnel both in San Diego and off-site contract partners.
  • Understanding of Manufacturing Statistical methods, such as process capability and Design of Experiments.
  • Understands and can apply statistical tools used to assist in development and troubleshooting of products and processes.
  • Project Management leadership in areas focusing on design changes, process improvements, outsourcing, material cost reduction, and other plant efficiency efforts.
  • Demonstrated ability to identify project requirements and develop schedules with little to no assistance from more senior level engineering
  • Develop and execute testing, verification, and documentation activities.
  • Follow design, quality, and safety guidelines based on GMP, FDA, and ISO guidelines and related Quality and Safety Standards and Practices.

Required Qualifications:

  • 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.
  • At least 5 years of hands-on experience with fixture and equipment development for assembly and automation systems. Robotics design and development is a plus. Controls experience is a plus.
  • General knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO); minimum 1 year working in a regulated environment preferred.
  • Familiarity with product safety and EMC compliance
  • Familiarity with OSHA safety and ergonomics compliance
  • Demonstrated ability to influence, motivate, and accomplish results through peers and junior level engineers
  • 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.
  • Ability to represent functional and operations organization with clarity and manage conflict resolution in wide variety of settings.
  • Supports and drives change management within function
  • Key functional or cross functional liaison with stakeholders concerning operational or project deliverables.
  • Medical device or regulated industry experience preferred.

Scope:

  • 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.

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.

#LI-FH1

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.





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Jobs Rated Reports for Mechanical Engineer

Posted: 2020-02-01 Expires: 2020-03-01

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Senior Mechanical Engineer - Automation

Dexcom
San Diego, CA 92101

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Mechanical Engineer
57th2018 - Mechanical Engineer
Overall Rating: 57/220
Median Salary: $85,880

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Growth
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