Operations Engineer II - Medical Device Start-up
Job Description:
We are seeking a highly skilled Operations Engineer II to join our team in establishing, optimizing, and scaling manufacturing operations for next-generation medical devices.
Key Responsibilities:
* Lead and support manufacturing process development, optimization, and validation for new and existing medical device products.
* Partner with R&D, Quality, and Supply Chain to support New Product Introduction (NPI) and design transfer into manufacturing.
* Develop and document manufacturing processes, work instructions, and test procedures to ensure consistent product quality and compliance.
* Plan and execute process validation activities (IQ/OQ/PQ) and associated documentation.
* Identify and implement process improvements to enhance yield, reduce cost, and increase efficiency.
* Support the introduction of new equipment, tooling, and fixtures, including qualification and calibration activities.
* Drive root cause analysis and CAPA initiatives to resolve manufacturing or quality issues.
Required Skills and Qualifications:
Essential qualifications include:
* Bachelor's Degree in Engineering (Manufacturing, Mechanical, Biomedical, or related discipline).
* Minimum of 3+ years' experience in a medical device manufacturing or operations engineering role.
* Proven experience supporting New Product Introduction (NPI) and process validation activities.
* Strong understanding of manufacturing process controls, root cause analysis, and risk management.
* Hands-on experience with process validation, equipment qualification, and documentation within a regulated environment.
* Proficiency in lean manufacturing and continuous improvement methodologies.
Benefits:
We offer:
* Opportunity to join a growing medical device start-up developing novel vascular technologies.
* Exposure to end-to-end product lifecycle, from concept through to commercial manufacturing.
* Collaborative and innovative work culture with opportunities for professional growth.
Others:
Our company specializes in sourcing professionals for key industries and services. Please see our website for more details.
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