JOB DESCRIPTION:Senior Project ManagerThe Opportunity The Senior Project Manager will lead complex, cross-functional projects within a regulated medical device environment, ensuring quality system compliance, effective risk management, and successful delivery across scope, cost, and timelines. It partners with internal teams and leadership to drive post-market surveillance, resolve quality issues, and implement process improvements while aligning projects to broader business and regulatory objectives.
What You'll Work On- Responsible for implementing and maintaining the effectiveness of the quality system.
- Define the business results expected from a project.
- Is responsible for making recommendations for achieving those results.
- Support corrective and preventative action (CAPA) plans to ensure that quality issues are properly investigated, resolved, and prevented from recurring.
- Collaborate with investigation and risk teams to support activities requiring product knowledge and associated risk.
- Results may be in terms of compliance with Post Market Surveillance policies, quality, time, scope and cost.
- Lead the team through the translation of management and customer needs into project goals.
- Identify resource requirements, cost and time schedules and participate in the funding process.
- Develop an implementation plan, conduct risk assessments, and develop and implement contingency plans to allow for and accommodate unforeseen events and changes in strategy.
- Maintain compliance with regulatory agencies, quality system, ethics policy and project goals.
- Assure that projects will effectively integrate with existing programs and strategies so that long and short term business goals are attained.
- Assure project requirements are met.
- Establishes and manages team charter including project timeline.
- Negotiate with resource managers to resolve any resource limitations that cannot be resolved by the team.
- Participate on division initiatives to identify process improvements to accelerate projects.
- Interface with other disciplines, customers, internal clients, project staff and internal and external experts as required.
- Prepare and present written and oral reports and other presentations to internal and external audiences.
- Interact with senior level management to present significant Program strategies and make recommendations.
Required Qualifications- Associates Degree with a minimum of 10 yrs industry experience or Bachelors degree with min of 7 yrs of industry experience. equivalent combination of education and work experience will be accepted.
- Min of 5 yrs experience with diabetes management experience is required.
Preferred Qualifications- Relevant experience, including business / QA experience.
- Experience in medical devices for diabetes management is preferred.
- Experience with complaint handling, regulatory reporting, or post market surveillance is preferred.
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Divisional InformationMedical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Diabetes
We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is $114,000.00 - $228,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Project Management
DIVISION:ADC Diabetes Care
LOCATION:United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
