Sr Process Development Engineer - Molding

Hybrid
Senior
🇲🇾 Malaysia
Engineering Manager
Technology

The Company

Dexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) 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 nearly 10,000 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 and automation houses. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for plastic injection molding process development and validation. You will play a pivotal role in ensuring robust new product introduction, capacity expansions, 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:

  • You will develop detailed thermoplastic injection molding process capability and optimization studies, validations for robust, sustainable commercial production, and implement improvements to enhance yield, quality, and efficiency.
  • You will have extensive experience in injection molding manufacturing for high-volume Class II medical devices.
  • You will have strong data analytics and statistical analytics capabilities, inclusive of development of robust DOEs with strong linkage to CPK and PPK requirements.
  • You will have experience in the defining the full injection molding work cell requirements, inclusive of tool and machine design and capabilities such a barrel and shot size with knowledge of their linkage to optimum product manufacturing performance.
  • You will support a range of programs from new product introductions and launches to scale up, on-market, and end of life management. Participating in molded component related development activities, ensuring seamless progression, timely feedback, and optimization, while fostering teamwork and accountability.
  • You will ensure adherence to design, quality, and safety standards, upholding GMP, FDA, and ISO guidelines. As well as support the planning and execution of robust validations and on-market change assessments.
  • You will collaborate closely with the Purchasing and Quality organizations to establish a rigorous supplier selection process, ensuring timely launches and sustained performance at the optimal cost profile.
  • You will provide technical support to suppliers and internal teams, ensuring adherence to sound engineering and operations practices throughout the supply chain, fostering strong partnerships and promoting a culture of excellence and continuous improvement.
  • You stay informed about advancing technologies and processes, and the competitive landscape, actively supporting the identification of opportunities for implementation.
  • You will provide technical insight in the development and implementation of on-market support initiatives, including a robust preventative maintenance management system, to maintain the yield, performance, and quality of products and subcomponents.

What makes you successful:

  • You have strong problem-solving and analytical skills, with the ability to interpret complex data and make informed decisions.
  • You can work effectively in a team environment, collaborating with cross-functional partners in manufacturing, R&D, supply chain, and quality assurance to achieve common goals.
  • You effectively communicate with internal teams and external partners. This includes conveying technical concepts clearly, providing timely updates, and fostering collaborative relationships to ensure alignment and successful project outcomes.
  • You must be able and capable to travel to our automation vendors and contract manufacturing partners to investigate production or quality related issues and troubleshoot equipment.
  • You collaborate with R&D on design for manufacturing considerations for new product development and work with injection molding toolmakers to assist in providing oversight into mold and part design for high-scale manufacturing. You support the development of productive partnerships for stable on-market performance and contribute to continuous improvement efforts.
  • You stay informed about advancing technologies and processes, and the competitive landscape, actively supporting the identification of opportunities for implementation.
  • You contribute to the innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications. You support the identification and implementation of technology and process solutions to enhance performance and achieve both short-term and long-term objectives.

Key Competencies:

  • Bachelor’s degree in mechanical engineering, plastics engineering, or a related field.
  • Profound knowledge of plastic injection molding processes, materials, tooling, and equipment, with the ability to troubleshoot complex issues and optimize processes.
  • Direct experience in injection molding manufacturing for high volume, Class II medical devices.
  • Experience in statistical process control (SPC) and use of software tools such as Minitab or JMP for data analysis.
  • Proficiency in SolidWorks and MoldFlow analysis.
  • Robust understanding of Plastic Part Design Guidelines, including dimensional tolerancing and GD&T Standards.
  • Demonstrated success in driving continuous improvement initiatives using LEAN, KAIZEN, and Six Sigma methodologies to significantly enhance process efficiency, reduce operational costs, and elevate product quality standards.

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.

 

Dexcom

Dexcom

Dexcom develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes

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Healthcare
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