Project Manager at Dexcom

Athenry, Athenry-Oranmore Municipal District, Ireland -

Full Time

Start Date

Immediate

Expiry Date

17 Mar, 26

Salary

0.0

Posted On

17 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Engineering, Automation, Manufacturing, Communication, Technical Leadership, Regulatory Compliance, FDA Regulations, ISO Standards, Process Improvement, Cross-Functional Collaboration, Risk Assessment, Logistics, Production Planning, Equipment Qualification, Change Control

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. Join our dynamic team as we navigate and lead Dexcom Global Operations (Ops) PMO programs and projects in an exciting, fast-paced area of bringing new vendors, equipment and our new factory into global production. As a key player, you'll adhere to project governance, driving cross-functional teams to help bring our Athenry facility to commercial readiness, interacting with production planning and procurement to help define logistics of SKU changes and inventory planning, and managing equipment design, development, and qualification to build product at internal and external manufacturing locations. You will lead cross-functional ops team(s) and collaborate with stakeholders to drive business needs. If you thrive in a high-growth, self-motivated, customer-centric, and collaborative setting, this is the place for you! Where you come in: You collaborate and bring program leadership to highly complex cross-functional Ops Programs from inception through commercialization to include: Operations focused on commercial readiness for the Athenry Facility. New and improved manufacturing equipment/moulds/automation qualification, implementation, and transfer into internal and external manufacturing facilities. Production scale-up of products/processes. Change Order Plan (COP) closure and if needed support FDA filing You collaborate and drive process improvement activities that involve complex equipment or facility changes or additions with manufacturing. You establish strategies, advise, and communicate project/program plan and status to management and cross-functional teams. You anticipate and prevent issues with schedule, resources, and scope. You drive risk assessment as well as resolution. You partner with functional leaders and team members to drive Ops critical path program activities/ resources/ costs across all departments including: Technical team (Mechanical, Process, Electrical, Software, and Automation Engineering), Manufacturing, Contract Manufacturing, Procurement, Master Planning, Logistics/Distribution, Facilities, EH&S and others (Regulatory Affairs, Ops Quality, Finance, IT, etc.) within the boundaries of an indirect reporting structure You have the ability and confidence to run projects and provide updates as well as other key meetings. You are responsible for compliance with medical device regulatory standards for all aspects of the program. You work directly with suppliers and corporate partners, as appropriate. What makes you successful: Typically requires a Bachelor's degree and a minimum of 5 - 8 years of related experience. You have knowledge and work experience in Engineering, Automation, and Manufacturing. You demonstrate successful management of technical projects and programs. You have excellent communication skills with the ability to convey technical and business information clearly and effectively through informal and formal documents, reports, and presentations to senior management. You bring technical leadership experience and an understanding of regulated change control, product development process and medical device design control manufacturing transfer. You have technical knowledge and an understanding of FDA/ISO regulations working with GMP's and ISO standards. You are proficient in Microsoft PowerPoint, Microsoft Excel, and project management tools (Smartsheet). Ideally, you have Program Management certification, i.e. PMP or equivalent. 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 5-15% Dexcom Warriors | Meet Dexcom heroes and read their stories | Dexcom Reviews | Dexcom Read success stories from people who rely on Dexcom CGM devices every day. At Dexcom, our customers are our heroes - read our Warrior stories to learn more. 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.

Responsibilities

You will lead cross-functional operations teams to ensure commercial readiness for the Athenry facility and manage the qualification and implementation of new manufacturing equipment. Additionally, you will drive process improvements and collaborate with various stakeholders to meet business needs.