We anticipate the application window for this opening will close on - 16 Jun 2026
About the RoleManages the operational documentation aspects of ongoing projects and serves as a liaison between project management and planning, project team, and line management and quality standards.
Manages the development and design of R&D Project documentation and implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
Responsible for Design Document/Records Maintenance/updates according Quality Regulation Standards.
Responsibilities may include the following and other duties may be assigned.On Site Role
- Responsible for execution and maintenance of Design Control quality records, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in the Change Management system, interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
- Monitors the project from initiation through delivery.
- Develops mechanisms for monitoring project/activities progress and for intervention and problem solving with project managers, line managers, and clients.
- Manages the development and implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
- An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies.
- Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower-level professionals.
- The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
- Manage the design records changes monitoring product implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products.
- Monitors change and project timeliness to ensure design records delivery on time according project plans.
- Support the PD Program Management Organization with any design change as required.
Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.- Bachelor's degree with 2+ years' experience in a regulated industry, or Advanced degree with 0 years of experience.
Nice To Have:- Project management
- Risk management and data-driven
- Quality management systems knowledge
- Regulatory compliance knowledge ISO Regulation and Medical Devices Regulations
Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & CompensationMiniMed offers a competitive salary and flexible benefits packageSalary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00
For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD.
Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
This position is eligible for a short-term incentive called the Short Term Incentive (STI).
At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.
For further details about our comprehensive benefits, we encourage you to visit the link below.
MiniMed Benefits Overview