Manager Mechanical Engineering - Process Engineering jobs in United States
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Dexcom · 5 hours ago

Manager Mechanical Engineering - Process Engineering

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM) aiming to improve human health. The Manager Mechanical Engineering - Process Engineering will provide technical leadership to engineers, overseeing the transfer of new product designs and ensuring robust manufacturing processes.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Manufacturing processesProcess validationProject managementTechnical leadershipDMAIC processLean manufacturingGMP/GLP operationsFDA regulationsSTEM degreeCollaboration skillsCommunication skillsProblem solving

Required

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
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

Preferred

Recommended to have a STEM degree with proven ability to work hands-on in a fast-pasted environment with competing priorities

Benefits

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.

Company

Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.

H1B Sponsorship

Dexcom has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)

Funding

Current Stage
Public Company
Total Funding
$2.16B
Key Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M

Leadership Team

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Jacob Leach
Chief Operating Officer
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Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
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Company data provided by crunchbase