Elos Medtech AB
Elos Medtech, a leading development and production partner for medical technology companies worldwide. At our locations in Sweden, Denmark, Switzerland, Germany, China, and the USA, Elos runs operations in four business areas - Dental, Orthopedics, Advanced Surgical and Precision. Elos Medtech has extensive expertise and specializes in development and design, along with contract manufacturing of medical devices, such as implants and instruments..
We are always aware of the millions of patients we can help worldwide and are committed to meeting and exceeding our customers' high expectations. The company, headquartered in Gothenburg, Sweden, employs more than 1,500 people worldwide. In a globally growing healthcare market, we are looking for a full-time NPI Project Manager to strengthen our team.
The NPI Project Manager leads the operation launch of new products within a highly regulated environment. This role ensures that new devices transition smoothly from R&D into compliant, scalable, and cost-effective manufacturing. The NPI Manager partners closely with engineering, quality, regulatory, supply chain, and manufacturing teams to deliver safe, effective products that meet FDA, ISO 14385, and global regulatory requirements.
YOUR ROLE
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 EDUCATION AND EXPERIENCE
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 SKILLS
Strong leadership skills and experience coordinating cross-functional teams Excellent analytical thinking and problem-solving skills Good communication skills and team oriented
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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 EDUCATION AND EXPERIENCE
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 SKILLS
Strong leadership skills and experience coordinating cross-functional teams Excellent analytical thinking and problem-solving skills Good communication skills and team oriented
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