Project Manager (Medical Devices/ Design Controls/ NPD/ Manufacturing/ Catheters)

• This Project Management opportunity supports Intravascular Lithotripsy (IVL) catheters within our Coronary and Peripheral Artery Disease Portfolios.
• This role reports into the Associate Director, PMO and 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.
• Communicates 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.
• Identifies, communicates, and manages 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.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

**BS Engineering & 5+ years of full cycle medical device project management

**Design controls, NPD and manufacturing

**PMP

** Intravascular Lithotripsy (IVL) catheters within our Coronary and Peripheral Artery Disease Portfolios

Required Qualifications: Bachelor’s Degree in Engineering

• 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.
• 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 manufacturing experience as project manager, manufacturing or quality engineer, or production.
• 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.
• Experience with product development projects involving a disposable and console (system).

Pulled from the full job description

• Health insurance
• Vision insurance
• Dental insurance
• Life insurance
• Disability insurance
• Commuter assistance