Staff Mfg Engineer - Single-Use Devices & Compliance

SoloPoint Solutions, Inc.; Campbell (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

SoloPoint Solutions, Inc. is seeking an experienced manufacturing leader to oversee production builds for single-use devices and consumables.

You will manage in-house activities and contract manufacturing to meet regulatory requirements, while coordinating cross-functional teams from concept to clinical testing. Responsibilities include partnering with supply chain, implementing process improvements, and developing MPIs/LHRs/DHRs in collaboration with R&D and Quality.

Qualifications

• BS in Engineering with 8+ years of experience or MS with 6+ years in the medical device industry.
• Background with single-use devices and consumables.
• Expertise in pilot and production line setup and validation in controlled environments.
• Knowledge of FDA QSR, ISO 13485, and MDD/MDR compliance.
• Deep understanding of GMP, GDP, and Design Control procedures.
• Experience with ERP, MRP, and documentation control systems.
• Familiarity with contractual frameworks including supply, services, and NDAs.

Responsibilities

• Oversee production builds for single-use devices and consumables, managing in-house activities and contract manufacturing relationships to ensure compliance with product plans and regulatory requirements.
• Coordinate cross-functional operations project teams from early conceptualization through clinical testing, managing schedules, timelines, and budgets.
• Partner with supply chain to track inventory, raw materials, and components per the build schedule, maintaining accountability for issued materials.
• Conceptualize and implement manufacturing improvements, tooling, and process technologies to decrease manual operations, improve repeatability, and increase yields.
• Collaborate with R&D and Quality to select suppliers, author manufacturing SOPs, and develop MPIs, LHRs, and DHRs.
• Conduct time studies, define in-process testing parameters, and lead continuous improvement projects with Quality to resolve yield and compliance issues.

Skills

Single-use devices background

Pilot & production line setup

QSR ISO13485 MDD/MDR compliance

GMP GDP & Design Control

ERP/MRP & documentation control

Contractual frameworks (supply,服务, NDA

Education

BS in Engineering with 8+ yrs or MS with 6+ yrs in medical device industry

Job description

SoloPoint Solutions, Inc. is seeking an experienced manufacturing leader to oversee production builds for single-use devices and consumables.

You will manage in-house activities and contract manufacturing to meet regulatory requirements, while coordinating cross-functional teams from concept to clinical testing. Responsibilities include partnering with supply chain, implementing process improvements, and developing MPIs/LHRs/DHRs in collaboration with R&D and Quality.