Project Manager III- Sustaining Products for Medical devices.

TALENT Software Services; Carlsbad (CA); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

TALENT Software Services is seeking a Project Manager to support sustaining IVL console products within our Coronary and Peripheral Artery Disease portfolios. This is an on-site role in Carlsbad, CA, five days a week.

You will manage projects from launch to end of life, coordinate cross-functional teams across sites, and establish milestones, governance, and status reporting. Requirements: Bachelor’s degree in engineering or related field; 6+ years in medical device project management with

Qualifikationen

• Bachelor’s degree in engineering or related field is required.
• 6+ years of experience as a Project Manager leading cross-functional medical device teams.
• Experience with design control for medical devices from launch to end of life.
• Software and/or hardware experience with product development involving a disposable and console (system).
• Excellent written and oral communication skills; ability to communicate to senior leadership.

Aufgaben

• Support sustaining strategy to ensure product continuity.
• Manage project structure and governance (scope, roles, and responsibilities, workstreams, risks, communication).
• Develop milestones and project plans for budget, resources, and execution tracking.
• Facilitate team decision-making by organizing information and evaluating options.
• Communicate project status and performance through standard status reports and dashboards.
• Coordinate cross-functional activities to evaluate, design, build, and implement solutions.
• Identify, communicate, and manage technical risk and knowledge gaps.
• Communicate key decisions, risks, and status updates to stakeholders and leadership.
• Support submission cadence planning with Regulatory to align R&D and business objectives.

Kenntnisse

Cross-functional leadership

Executive communication

Design control

Project governance

Ausbildung

Bachelor's degree in engineering or related field

PMP certification

MBA or master’s degree

Tools

MS Project

Office Timeline

Jobbeschreibung

Work mode: On-site (5 days a week)
Onsite Location: Carlsbad, CA
Interview schedule: 2 rounds, 1st with HM and/or Sr Console Project Manager. 2nd with cross-functional panel.
Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. Client is not able to consider candidates who require sponsorship.

About the role:

• This Project Management opportunity supports Intravascular Lithotripsy (IVL) console sustaining within our Coronary and Peripheral Artery Disease Portfolios.
• This role will manage sustaining projects and activities from initial launch to product end of life. Projects range in size from small one-off tasks to moderate process improvement, design change, and design transfer.
• Works directly with cross-functional partners across business units and global manufacturing sites.

Your Responsibilities include:

• Support and execute the sustaining strategy to ensure product continuity.
• Manage project structure and governance (scope, roles & responsibilities, workstreams, risks, communication & alignment, etc.) for project activities.
• Develop key project milestones and project plans to support budget, resource planning, and execution tracking.
• Facilitate team decision-making by organizing information, evaluating options, and supporting clear recommendations.
• Communicate project status & performance by preparing standard status reports/dashboards and facilitating status update meetings.
• Coordinate cross-functional team activities to evaluate, design, build, and implement solutions that support project outcomes.
• Identify, communicate, and manage technical risk and knowledge gaps.
• Communicate key decisions, risks, and status updates to project stakeholders and leadership as appropriate.
• Support submission cadence planning in partnership with the Regulatory function to help prioritize R&D, process improvement, and business continuity projects in alignment with strategic business objectives.

Required Qualifications:

• Bachelor’s Degree in engineering or related field
• 6+ years of experience as a Project Manager or similar position with demonstrated success in leading cross-functional teams utilizing the design control process for medical devices from initial launch to product end of life
• Software and/or hardware experience with product development projects involving a disposable and console (system)
• Strong business acumen & strategic thought leadership
• Excellent written and oral communication skills; ability to communicate fluently and concisely to senior leadership

Preferred Qualifications and Competencies:

• PMP certification and MBA or master’s level degree
• Previous experience as project manager, manufacturing engineer, or quality engineer
• Candidate to be comfortable in front of all levels of the organization as well as external customers
• Candidate to have strong leadership and interpersonal skills and ability to build relationships within project teams
• Problem-solving technical expertise
• Proficient with MS Project & Office Timeline