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Senior Engineer in Manufacturing Processes

2 months ago

San Jose, California, United States Visby Medical Full time
Job Overview

About Visby Medical

Visby Medical is a pioneering and well-capitalized biotech startup focused on transforming the landscape of infectious disease diagnostics. Our innovative approach has led to the creation of the first single-use PCR platform, which aims to enhance the speed, accuracy, and accessibility of testing and treatment for infectious diseases.

Position Summary

The Senior Manufacturing Engineer specializing in Mechanical Design and Automation will play a crucial role in enhancing component and subassembly designs for production. This position involves the development and optimization of manufacturing processes and equipment to ensure the safe, high-quality, and cost-effective production of our medical devices.

Key Responsibilities

  • Oversee the entire manufacturing engineering design process, including concept development, design execution, drawing generation, equipment installation, and ongoing technical support, while ensuring adherence to quality, capability, cost, and timeline objectives.
  • Design and create assembly tooling and process layouts.
  • Develop robotic systems for plastic welding (using laser or ultrasonic methods) and material handling.
  • Construct and refine mechanical assembly systems.
  • Lead capital and expense projects by researching both new and established manufacturing technologies, planning implementation timelines, and drafting Capital Expenditure Request (CER) proposals.
  • Manage equipment procurement.
  • Create and maintain CAD models, drawings, and assemblies in accordance with the Bill of Materials (BOM) structure using software PDM.
  • Draft and update equipment manuals and operational instructions.
  • Support the installation and qualification of equipment and processes.
  • Operate in compliance with GMP and the company’s Quality Management System (QMS).
  • Contribute to ongoing improvements in manufacturing efficiency, product quality, and team dynamics.
  • Adhere to established quality policies and operational guidelines.
  • Foster a safe and collaborative working environment.

Qualifications

  • Bachelor's degree in engineering with a minimum of 8 years of relevant experience.
  • A Master's degree in an engineering discipline is advantageous.
  • Experience in designing and laying out automation cells is preferred.
  • Proficiency in 3D modeling, particularly with SolidWorks and PDM Vault.
  • Ability to interpret mechanical drawings and apply GD&T principles.
  • Experience in an ISO environment, particularly within the FDA-regulated medical device sector, is a plus.

Preferred Skills

  • Capability to work autonomously as well as collaboratively to resolve technical challenges.
  • Strong analytical skills and technical problem-solving capabilities.
  • Excellent communication skills with a keen attention to detail.

Unique Job Features

  • Physical ability to lift at least 20 lbs.
  • Mobility within the manufacturing facility is essential for accessing files, equipment, and attending meetings.
  • Must be capable of leading the assembly of mechanical and electrical designs, making necessary adjustments.
  • Ability to work in a low humidity environment (