We are seeking a highly motivated and experienced Production and Quality Engineer to join our dynamic team. This is a critical, cross-functional role focused on ensuring the sustained and scalable production of our innovative device, while maintaining the highest standards of product quality, process readiness, and production continuity.
As a Production and Quality Engineer, you will be instrumental in bridging the gap between design and manufacturing, owning key engineering tasks across mechanical, electrical, and system-level components. This includes vital responsibilities such as Bill of Materials (BOM) validation, robust test system support, and seamless interface with our contract manufacturers (CMs). You will also play a pivotal role in supporting crucial New Product Introduction (NPI) activities.
Key Responsibilities:
Production Engineering:
Maintain and update the production tree (BOM structure) for the device and all associated hardware and accessories.
Proactively ensure that all products can be manufactured with a minimum of two approved BOM alternatives, strategically mitigating single-point-of-failure risks.
Define, develop, and provide comprehensive support for production test systems, fixtures, and calibration protocols, while continuously improving production costs and efficiency.
Develop clear and precise production instructions to support manufacturing across all production sites.
Act as the primary interface with production partners, implementing manufacturing best practices and swiftly resolving production-related issues.
Quality Engineering:
Lead investigations and resolve production and field quality issues through rigorous root cause analysis and the implementation of effective corrective action plans (CAPAs).
Define, implement, and continuously monitor quality control protocols, test methods, and inspection guidelines to uphold product excellence.
Maintain traceability and comprehensive documentation for all production and Quality Assurance (QA) processes.
Engineering & Change Management:
Lead the efficient execution of Engineering Change Orders (ECOs) and maintain precise SKU/version management for all products.
Coordinate seamlessly with engineering, logistics, and suppliers to ensure the effective and timely rollout of all changes.
Provide essential support for the launch and configuration of accessory SKUs and bundles as required.
Production Risk Mitigation:
Proactively identify and address risks associated with single-source components, tools, materials, and other critical aspects of the production process.
Work collaboratively to define and qualify alternative components and production paths to ensure continuity.
Plan and manage the tooling roadmap to strategically support future production scalability.
Cross-Functional Support:
Collaborate closely with hardware engineering, supply chain, and logistics teams to ensure optimal production alignment and efficiency.
Provide robust support for internal and external operations projects.
As a Production and Quality Engineer, you will be instrumental in bridging the gap between design and manufacturing, owning key engineering tasks across mechanical, electrical, and system-level components. This includes vital responsibilities such as Bill of Materials (BOM) validation, robust test system support, and seamless interface with our contract manufacturers (CMs). You will also play a pivotal role in supporting crucial New Product Introduction (NPI) activities.
Key Responsibilities:
Production Engineering:
Maintain and update the production tree (BOM structure) for the device and all associated hardware and accessories.
Proactively ensure that all products can be manufactured with a minimum of two approved BOM alternatives, strategically mitigating single-point-of-failure risks.
Define, develop, and provide comprehensive support for production test systems, fixtures, and calibration protocols, while continuously improving production costs and efficiency.
Develop clear and precise production instructions to support manufacturing across all production sites.
Act as the primary interface with production partners, implementing manufacturing best practices and swiftly resolving production-related issues.
Quality Engineering:
Lead investigations and resolve production and field quality issues through rigorous root cause analysis and the implementation of effective corrective action plans (CAPAs).
Define, implement, and continuously monitor quality control protocols, test methods, and inspection guidelines to uphold product excellence.
Maintain traceability and comprehensive documentation for all production and Quality Assurance (QA) processes.
Engineering & Change Management:
Lead the efficient execution of Engineering Change Orders (ECOs) and maintain precise SKU/version management for all products.
Coordinate seamlessly with engineering, logistics, and suppliers to ensure the effective and timely rollout of all changes.
Provide essential support for the launch and configuration of accessory SKUs and bundles as required.
Production Risk Mitigation:
Proactively identify and address risks associated with single-source components, tools, materials, and other critical aspects of the production process.
Work collaboratively to define and qualify alternative components and production paths to ensure continuity.
Plan and manage the tooling roadmap to strategically support future production scalability.
Cross-Functional Support:
Collaborate closely with hardware engineering, supply chain, and logistics teams to ensure optimal production alignment and efficiency.
Provide robust support for internal and external operations projects.
Requirements:
5+ years of hands-on experience in production engineering, quality engineering.
Strong, proven understanding of Bill of Materials (BOMs), Engineering Change Orders (ECOs), production test processes, and successful collaboration with Contract Manufacturers (CMs).
Familiarity with established quality systems (e.g., ISO 9001, ISO 13485) and proficient in failure analysis techniques.
Demonstrated ability to manage complex cross-functional technical projects and communicate clearly and effectively with diverse stakeholders.
Fluent in English, with excellent organizational and meticulous documentation skills.
"Startup-ready" mindset: Comfortable working independently, managing multiple priorities, and thriving across disciplines in a fast-paced, dynamic environment.
Familiarity with medical 510K Class I or II – An advantage.
Hands-on experience with test fixtures, calibration tools, and factory bring-up – An advantage.
5+ years of hands-on experience in production engineering, quality engineering.
Strong, proven understanding of Bill of Materials (BOMs), Engineering Change Orders (ECOs), production test processes, and successful collaboration with Contract Manufacturers (CMs).
Familiarity with established quality systems (e.g., ISO 9001, ISO 13485) and proficient in failure analysis techniques.
Demonstrated ability to manage complex cross-functional technical projects and communicate clearly and effectively with diverse stakeholders.
Fluent in English, with excellent organizational and meticulous documentation skills.
"Startup-ready" mindset: Comfortable working independently, managing multiple priorities, and thriving across disciplines in a fast-paced, dynamic environment.
Familiarity with medical 510K Class I or II – An advantage.
Hands-on experience with test fixtures, calibration tools, and factory bring-up – An advantage.
This position is open to all candidates.
