Program Manager

Mindlance; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

A medical device company in Minneapolis seeks an experienced project manager to lead multiple projects within its Restorative Therapy Group. The successful candidate will apply extensive knowledge of CAPA and risk management to ensure compliance with regulations while managing risks, executing product development projects, and leading cross-functional teams. Strong leadership skills and a proven track record in project management are essential for delivering high-quality work on time and within budget.

Qualifications

• Extensive knowledge of CAPA and risk management in medical devices.
• Experience leading multiple concurrent projects or large-scale programs.
• Ability to provide recommendations to management and work within cross-functional teams.

Responsibilities

• Oversee project management within Restorative Therapy Group.
• Ensure compliance with medical device regulations.
• Lead and coordinate cross-functional teams on strategic projects.

Skills

Project management leadership

Compliance with regulations

Risk Management

CAPA processes

Collaboration with SMEs

Job description

• CAPA design projects, risk managements, he/she should be a SME ( should have medical device projects)
• Responsible for project management leadership and the day-to-day management of critical projects within Restorative Therapy Group (RTG) Sector’s Released Product Engineering (RPE) Department. Lead several different projects concurrently, coordinating with Subject Matter Experts (SMEs) and others for project execution activities. Accountable for developing detailed work plans, creating/revising estimates, coordinating resource needs, and providing financial oversight. Manage risks and issues, taking action to direct analysis and come to resolution. Track and communicate project status, elevate issues, and manage to scope, schedule, and budget constraints while ensuring quality deliverables on the project.
• Apply extensive knowledge and expertise to ensure compliance to Design Control, Risk Management and Corrective Action and Preventative Action (CAPA) processes while meeting the intent of Medical Device regulations and requirements. Serve as a CAPA Owner or Project Manager and as a Develop Products, Risk Management and CAPA Process Subject Matter Expert (SME) within the Released Product Engineering (RPE) Department. Provide recommendations and guidance to RPE Management, New Product Introduction (NPI) and the CAPA Board Chairs, and work closely with CAPA Board Members in the development and execution of Develop Products, Risk Management and CAPA activities and the rigorous assessment of all associated quality records and documentation.
• Lead cross-functional teams on key strategic projects, responsible for coordinating multiple concurrent projects or a single large-scale, complex program; execute Product Development, Remediation and CAPA Projects with rigorous Project Management discipline
• Provide project leadership to achieve project objectives with high-quality work products that are delivered on time and on budget; management of project activities and documentation to assure compliance with Design Control, Risk Management and CAPA processes through the development and review of Develop Products and CAPA records at critical phases

Additional Information

All your information will be kept confidential according to EEO guidelines.