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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing New Product Development projects within the medical device sector, with a strong focus on compliance with ISO 13485 and design controls. Proven ability to lead cross-functional teams, establish project plans, and deliver projects on time and within budget.
Highest-signal resume keywords
New Product Development ManagementISO 13485 ComplianceProject Management CertificationCross-Functional Team LeadershipWound Care Product Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementBudget PlanningRisk ManagementDesign ControlLifecycle Management
Soft Skills
Communication SkillsTeamwork SkillsLeadership Skills
Tools & Technologies
MS WordMS ProjectMS ExcelMS PowerPointMS TeamsDatabase SoftwareMS OutlookProject Management Cloud Software
Certifications & Qualifications
PMPAPM
Industry Keywords
Medical DeviceWound CareProject Management OfficeGate ReviewsIDEAL Process
Tech Stack
Tools & technologiesCloudPMP
About the role
Key responsibilities & impact- Oversee project management, planning, execution, tracking, and reporting for Advanced Wound Care new product development and lifecycle management projects
- Drive cross-functional project and program execution with R&D, Quality, Regulatory, Operations, and Commercial teams
- Manage and deliver high-priority projects on time, within scope, and within budget
- Establish and nurture a high-performing team culture
- Establish core project teams and coordinate assigned New Product Development and Lifecycle Management projects
- Create detailed project plans, sequence activities, and establish required resources
- Support annual project budget planning and coordinate monthly spend predictions and accruals with Finance
- Integrate workstreams into master schedules
- Establish communication plans and manage stakeholders
- Review project schedules and progress with senior management and project team members
- Identify and mitigate project risks and escalate issues as appropriate
- Manage compliance with Design Control and Business processes, including Gate reviews and the IDEAL new product development process
- Maintain complete project documentation and archives
- Create agendas, chair meetings, and maintain records of actions, decisions, and risks
- Support the PMO in developing and enhancing project management tools, processes, and systems
Requirements
What you’ll need- 7+ years of experience successfully managing and delivering New Product Development projects for a medical device company
- Good understanding of ISO 13485 and design controls
- Prior experience developing wound care products strongly preferred
- Strong proficiency in MS Word, MS Project, MS Excel, MS PowerPoint, MS Teams, database software, MS Outlook, and Project Management Cloud Software
- Strong communication skills, including clear, thorough, and timely speaking, listening, and writing
- Leadership and teamwork skills, with the ability to develop others, network across a complex organizational hierarchy, and work cooperatively to set goals and resolve problems
- BS in Engineering or Science discipline
- MS preferred
- Project management certification preferred (PMP, APM or equivalent)
Benefits
Comp & perks- Travel up to 25% of the time within the United States and Europe
- Primarily remote working
- Opportunities to work with cross-functional teams and develop project management tools, processes, and systems