Manager Mechanical Engineering - Process Engineering at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Apr, 26

Salary

225100.0

Posted On

24 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Engineering, Project Management, Lean Manufacturing, Process Validation, Risk Management, GMP Operations, FDA Regulations, ISO Standards, Collaboration, Technical Leadership, Manufacturing Processes, Product Testing, Continuous Improvement, Problem Solving, Data Analysis, Communication

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: You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures, automation houses, and internal manufacturing. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the development, qualification, validation and change management of complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in Operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansion, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in: The Manager is responsible for providing technical leadership to engineers and direct reports to: Oversee the project scope: Transfer of new product designs, associated manufacturing processes, test methods, and equipment to ensure proper product functionality and cost effectiveness at a manufacturing scale. Ensure upcoming design changes follow Design Control and prepare proper plans and documentation for implementation. Review, evaluate, and implement engineering changes and specification requirements as required. Demonstrate the ability to apply manufacturing workflow understanding across new product lines, custom and commercial-off-the-shelf automation, analytical testing equipment, and facilities equipment. Demonstrate hands-on manufacturing workflow and product testing understanding, as it relates to product design and process specifications Provide leadership and strategic direction to staff involved in product/process investigations, ensuring timely resolution and compliance with product quality standards. Demonstrate the ability to provide executive leadership with concise technical status and risk management updates both written and verbal. Evaluate production/equipment/process efficiencies, variances, and procedures on a continuous basis for process improvement and to reduce the variable standard cost. Lead continuous improvement roadmaps and strategies. Organize and generate detailed information reports to show trends and impact of equipment/process performance and improvements. Exhibit strong collaboration skills by effectively engaging with cross-functional teams outside of engineering such as Finance, Logistics, Trade Compliance, Legal, and Strategic Sourcing. What makes you successful: The Mechanical Engineering Manager is responsible to maintain proper product functionality, develop and sustain manufacturing processes, and equipment within the San Diego Manufacturing site through: Proven experience managing engineers and scientists, with cross functional disciplines, focused on manufacturing processes, product release testing, and investigations. Knowledge of DMAIC process, structure problem solving, lean manufacturing and project management with proven success of implementation. Knowledge in equipment qualification and process validation in a regulated industry, specifically VMP/VMR, IQ/OQ/PQ, DOE, and TMV. Proven experience tracking and managing technical risks and providing engineering guidance on selecting mitigation strategies. Experience informing finance business partners on technical project variables to develop accurate project budgets from feasibility through verification and validation. Skilled at transforming complex situations into well-defined project/process deliverables. Proven engineering experience supporting and managing regulated GMP/GLP operations, preferably in medical device, medical diagnostic, and/or pharmaceutical industries. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems). Excellent written and oral skills, driving efficient and effective communication cross functionally. Proven ability to collaborate and drive results in a matrix organization. Recommended to have a STEM degree with proven ability to work hands-on in a fast-pasted environment with competing priorities. 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: 15-25% Experience and Education Requirements: Typically requires a Bachelor’s degree with 8-12 years of industry experience Requires a degree in a technical discipline 2-5 years of previous management or lead 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: $135,100.00 - $225,100.00 Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

Responsibilities

The Manager is responsible for providing technical leadership to engineers and overseeing the project scope for new product designs and manufacturing processes. This includes ensuring compliance with product quality standards and leading continuous improvement initiatives.