Dexcom Deutschland GmbH · 10 hours ago
Manager Mechanical Engineering - Process Engineering
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$135K/yr - $225K/yr
8+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Manager Mechanical Engineering - Process Engineering will provide technical leadership to engineers and oversee the transfer of new product designs and manufacturing processes to ensure proper product functionality and cost effectiveness.
Medical Device
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
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 Deutschland GmbH
Die 1999 gegründete Dexcom, Inc.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase