Senior Engineer

Mid-Level Mechanical Engineer to drive design, design verification, manufacturing scale-up, automation, continuous improvement, and sustaining engineering initiatives. Operating within an ISO 9001 quality management system for diagnostics and medical devices, this role bridges the gap between R&D and production. The Sr. Engineer will own design transfers, optimize manufacturing performance, solve complex technical problems independently, and contribute directly to new product development.

Working in a fast-paced CDMO environment, they will collaborate cross-functionally to improve product quality, reduce costs, and support strategic client initiatives from concept to commercialization.

• Leads design and development of moderately to highly complex diagnostic sub-assemblies and modules (e.g., fluidic cartridges, optical interfaces, electromechanical systems), owning execution from concept through verification and design transfer with minimal supervision.
• Design diagnostic sub-assemblies and modules like fluidic cartridges, optical interfaces, and electromechanical systems from concept through design transfer using Solid Works.
• Apply advanced GD&T and perform tolerance stack-up analyses to ensure high-yield manufacturing and proper component fit.
• Perform engineering analyses including structural, thermal, fluidic, and FEA, validating results through hands-on prototyping.
• Own technical decisions within assigned scopes, balancing trade-offs between performance, cost, manufacturability, and quality standards.
• Implement manufacturing automation and continuous improvement initiatives to increase throughput, optimize processes, and reduce production costs.
• Support production lines by troubleshooting daily technical issues to improve line efficiency and on-time delivery.
• Lead root cause analysis (RCA) for component or process failures and implement robust corrective/preventive actions.
• Manage engineering changes seamlessly from initial identification through final production release.
• Develop and execute verification and validation (V&V) plans, including hands-on testing of fluidic and electromechanical systems.
• Maintain documentation and Design History Files (DHF) in strict compliance with ISO 9001 and client quality standards.
• Interface with customers directly through regular technical meetings, milestones, and design reviews.
• Collaborate with suppliers to resolve technical fabrication issues, source components, and ensure part quality.
• Work as directed by manager.

• Report and take required action regarding injuries, incidents, medical, and accidents required by policy.
• Make the health, safety, protection of rights, and the development of all employees your primary responsibilities.
• Effectively manage medical and first aid emergencies.
• Follow all agency safety/medical related policies and procedures.
• Follow fire evacuation and disaster procedures correctly and in a timely manner.
• Report unsafe situations immediately; ensuring safety is imperative.
• Ensure pertinent emergency telephone numbers are readily available.
• Report symptoms and signs of communicable diseases immediately.
• Consistently use universal precautions.
• Report any incident that could potentially result in negative reactions from the community, law enforcement officers, and other agencies to the supervisor immediately.

• Bachelor’s degree in mechanical engineering or a related technical discipline.
• Experience:
  
  5–8 years of progressive engineering experience, ideally within a regulated product environment.
• CAD Expertise:
  Proficiency in Solid Works for component and assembly design.
• GD&T & Tolerance Analysis:
  Strong expertise in geometric dimensioning…