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Elos Medtech · 1 week ago

NPI Project Manager

Memphis, TN

Full-time

Onsite

Senior Level

5+ years exp

Elos Medtech is a leading development and production partner for medical technology companies worldwide. They are seeking a full-time NPI Project Manager to lead the operation launch of new products within a highly regulated environment, ensuring a smooth transition from R&D to compliant manufacturing.

Health CareLocal BusinessManufacturingPersonal Health

Responsibilities

Lead new product introduction with R&D, Quality, Operations, and our customers, ensuring completion within the specified goals, timeline, quality requirements, and budget

Identify the risks and opportunities during the project and develop strategies for risk mitigation

Communicate with internal and external stakeholders to ensure project goals and requirements are understood and met

Coordinate the project team and ensure effective collaboration between all team members

Report on project progress adherence: schedules, quality compliance and supply chain readiness

Develop validations and qualifications together with Quality Assurance in compliance with relevant medical regulations (e.g. ISO 13485, 21 CFR part 820, and MDR)

Support R&D and operations with technical questions and make clarifications with customers

Qualification

Medical device experienceRegulatory complianceProject managementMechanical engineeringAnalytical thinkingLeadership skillsProblem-solving skillsCommunication skillsTeam oriented

Required

Bachelor's degree in mechanical engineering or related technical field

5 years of experience in project management in a quality regulated environment, preferably in the medical device field

Strong leadership skills and experience coordinating cross-functional teams

Excellent analytical thinking and problem-solving skills

Good communication skills and team oriented

Company

Elos Medtech

Elos Medtech employs 1,500 people in four business units – Dental, Orthopedics, Advanced Surgical and Precision - and the divisions Medical Polymer Solutions, Sterile Packaging Solutions and Medical Value Solutions.

Founded in 1923

Gothenburg, Vastra Gotaland, SWE

1001-5000 employees