Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
Assists Project Development activities for highly technical project(s) from concept to commercialization on-time while meeting the product performance and quality requirements. Practical experience and solid understanding of the Product Development Process, specifically Medical Device Development, Verification & Validation activities, and Clinical testing. Collaborate with the subject matter experts and functional managers across the organization to ensure project's steady progress. Provide expeditious issue resolution with minimum supervision. Plan and coordinate the procurement, storage and distribution of materials in support of R&D product development and testing needs.
Essential Duties and Responsibilities:
* Assist project team in conducting up-front technical concepts and feasibility studies.
* Assist Program Manager in formulating project scope and detailed technical requirements.
* Develop detailed project schedule and organize cross-functional team to carry out the approved project plan with assistance from functional managers.
* Collaborate with Program Manager to effectively manage priorities. Perform risk assessment, develop contingency plans, and escalate issues resolution to the proper decision makers to avoid project slips.
* Coordinate engineering activities, pre-production builds and product verification and validation.
* Lead periodic cross-functional meetings, focusing on the clear identification of risks, technical challenges and roadblocks and developing speedy resolutions.
* Generate progress reports and deliver periodic project status updates.
* Facilitate design and feasibility reviews and support Phase Exit Reviews.
* Implement and evaluate inventory control measures to ensure inventories are at optimal levels and are fully supportive of R&D labs and Pilot lines schedules.
* Prepares and processes requisitions for materials and equipment.
* Maintains records of goods ordered and received.
* Other duties may be assigned as required.
* Must possess excellent project management skills, including demonstrated ability to develop and manage project plan with detailed schedule, establish priorities, work to deadlines and be able to control several projects of various technical nature and in various stages of development.
* Knowledge of medical device design control requirements is preferred. Working knowledge of GMP's and ISO standards is highly preferred.
* Proven experience in driving Quality Assurance at all stages of product development.
* Excellent communication skills with the ability to convey technical and business information clearly and effectively through documents, reports, and presentations to management.
* Strong initiative, self-driven to deliver results without daily supervision
* Must be highly collaborative and able to work in a team-based environment.
* Strong organizational skills. Team building and team leadership skills.
* Ability to coordinate and organize prototype materials, shipments and builds.
* Materials management experience in forecasting, procuring, inventory planning and management.
* Knowledge of ERP planning/forecasting tools - Oracle preferred
* Proficiency in Microsoft Office, Microsoft Project, and Visio is required.
* Proficiency in Confluence and JIRA is preferred.
* Ability to manage conflict professionally, strong "can do" attitude
* Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years equivalent industry experience.
Funcitonal Description: Technical Individual Contributor
Manages the development and implementation process of a company's projects. Coordinates departmental or cross-functional teams, focused on delivering new or upgrading existing products. Monitors the project from initiation through delivery including planning and directing schedules, assessing scope, and monitoring budget/spending. Organizes cross-functional activities, monitoring team performance, and ensuring completion of the project i.e. product on schedule and within budget constraints.
* Possesses a high level of theoretical knowledge. Ability to deliver technical ideas that have an impact on the objectives. Understands organizational and functional processes and policies aligned to the technical and business goals.
* Demonstrates technical proficiency. Works on moderately complex problems where analysis of situations or data requires evaluation. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Interprets data and draws conclusions regarding results used in presented material.
* Exercises judgment within defined procedures and practices to determine appropriate action.
* Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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 Talent Acquisition at firstname.lastname@example.org.
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 is a company that develops, manufactures and distributes continuous glucose monitoring systems for diabetes management.