Senior Hardware Production Specialist
2 weeks ago
The Operations and Service Engineer will oversee hardware production and maintenance activities, including coordination with contract manufacturers, distribution centers, and field operations.
This role requires on-site work at our manufacturing and field locations as needed. The successful candidate will ensure the delivery of products and hardware asset management activities, compliance with industry standards and regulations, high-quality manufacturing performance, cost efficiency, and continuous improvement initiatives.
- Technical leadership in manufacturing transfers and ramp-ups of new and existing products, supporting manufacturing transitions using design for manufacturability principles.
- Development and implementation of field service capabilities, including installation, servicing, and repair of products onsite at clinical sites and third-party repair centers.
- Management of quality processes, including NCMRs, CAPAs, supplier monitoring, audits, risk management, and internal controls, ensuring compliance with ISO 13485 and other relevant medical device standards.
The ideal candidate will have a bachelor's degree in engineering or a related field, with at least 10 years of experience, including 5 years in a technical leadership role within the medical device industry.
Key Skills and QualificationsEducation: Bachelor's degree in engineering or a related field.
Experience: At least 10 years of experience, including 5 years in a technical leadership role within the medical device industry.
Skills: Technical leadership, manufacturing transfers, field service capabilities, quality management, and ISO 13485 compliance.
What We OfferA competitive compensation package and opportunities for professional growth and development.
Why This Role MattersThis role is critical to delivering high-quality products and services to our customers and ensuring compliance with industry standards and regulations.
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