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.
Lead Project Development activities for highly technical project(s) from concept to commercialization on-time while meeting the product performance and quality requirements. Ability to coordinate project integration activities and manage Cross Functional development teams without direct supervisory responsibility. 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 organization to ensure project’s steady progress. Provide expeditious issue resolution with minimum supervision.
Promote professionalism, initiative, accountability, effective communication, and transparency on all levels.
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 conduct Phase Exit Reviews.
- Mentor less-senior personnel in aspects of project management best practices.
- 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.
- 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
- Program Management certification, i.e. PMP or equivalent
Requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience in product development in a medical device, pharmaceutical industry, or other regulated environment experience is highly preferred.
Functional 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 broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
- Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an indepth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Exercises good judgment in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day-to-day work, general instructions on new 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 [email protected].
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