Process Engineer
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We're looking for Medical Device - NPI Engineer / Process Engineer
As an NPI Engineer in our medical devices manufacturing team, you will be responsible for leading the development and implementation of new product introductions. You will collaborate cross-functionally to ensure that products meet regulatory standards, quality expectations, and market requirements. Your expertise will play a vital role in transitioning products from development to production efficiently and effectively.
Key Responsibilities:
- Lead and manage the new product introduction process from concept to commercialization.
- Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to define product specifications and requirements.
- Develop and maintain project plans, timelines, and budgets for NPI projects.
- Conduct risk assessments and implement strategies to mitigate potential issues during product development and production.
- Ensure compliance with FDA regulations, ISO standards, and other applicable guidelines.
- Coordinate and execute validation and verification activities for new products, including design verification and process validation.
- Analyze and interpret data related to product performance, quality, and reliability.
- Provide technical support and training to production teams during the ramp-up phase.
- Facilitate communication between stakeholders, ensuring alignment on project goals and progress.
- Continuously seek process improvements and efficiencies within the NPI framework.
Qualifications:
- Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or equivalent experience.
- [3-5+] years of experience in NPI, product development, or manufacturing engineering within the medical device industry.
- Strong understanding of regulatory requirements (CE, FDA, ISO 13485) and quality systems in the medical device sector.
- Proficiency in project management tools and methodologies.
- Excellent problem-solving, analytical, and communication skills.
- Experience with design control processes and product lifecycle management.
- Ability to work collaboratively in a team environment and manage multiple projects simultaneously
- Experience with Lean Manufacturing and Six Sigma methodologies.
- Familiarity with CAD software and product design tools.
- Previous experience in a GMP environment.
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