Senior Manufacturing Engineer

Company: XCath Inc.
Location: Houston
Posted on: January 28, 2023

Job Description:

Job DescriptionXCath is currently seeking a highly motivated Sr. Manufacturing Engineer to join our innovative and evolving medical device startup. The successful candidate will hold progressive experience in process development within a FDA cGMP regulated environment with working knowledge of GMP Design Controls to design, fabricate, test, and participate in the product and manufacturing process development activities of the cutting-edge endovascular 'smart' guidewires. This role calls for sound orientation with "Design for Manufacturability" principles and skilled execution of process capability design of experiments. Outputs shall include but not be limited to design verification, testing, product configuration, assembly, process validation and improving manufacturing processes in terms of cGMP documentation process characteristics integrity, characterization of quality and performance measurements, workforce development and productive throughput capacity for scalability.Duties and Responsibilities

• Evaluate manufacturing processes by designing and conducting experiments; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors and operators
• Evaluate, schedule, assign and manage work order requests within the assigned area
• Develop/Improve manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment
• Manage the adherence to prescribed procedures to ensure product quality meets or exceeds planned goals
• Prepare product reports by collecting, analyzing, and summarizing information and trends
• Assure product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes
• Communicate with vendors regarding outsourced manufacturing
• Provide technical guidance and support to manufacturers to maintain quality of work
• Be aware of and comply with regulatory requirements that are applicable to XCath, including but not limited to the 21CFR820, ISO 13485 and other regulations as applicable
• Maintain equipment by coordinating maintenance and repair services and following manufacturer's instructions and established procedures
• Fabricate / integrate small objects under a microscope as part of the process
• Train applicable staff on testing and manufacturing processes
• Participate in quality control/assurance related activities
• Perform other duties as requiredRequired Education and Experience
  • Mechanical, Biomedical Engineering or Materials Engineering degree (other Engineering or technical degree is acceptable with prior medical device development experience)
  • 5+ years engineering experience in the medical device industry in a manufacturing setting
  • Must have a great attention to detail and experience in assembly of small components
  • Ability to articulate clearly; professional oral and written communication skills
  • Must be proficient in general computer programs such as Microsoft Office
  • Strong planning, technical, and problem-solving skills
  • Ability to prioritize and multi-task with little supervision
  • Previous work experience should demonstrate "out of the box" thinking, strong conceptual, design, and analysis skills, self-motivation, flexibility, detail-oriented work style.
  • Ability to understand and create engineering schematics
  • Knowledge of FDA regulations (21CFR 820), ISO standards (ISO 13485), and other regulations as applicablePreferences
    • 3-5 years' experience in an endovascular medical device setting (guidewire, catheter)
    • Strong in process validations and experienced in working cross-functionally
    • Project management skills
    • Strong foundation in statistics to complement their process validation strengthsBenefits
      • 401(k)
      • Health insurance
      • Paid time off
      • Dental insurance
      • Vision insurance

Keywords: XCath Inc., Houston , Senior Manufacturing Engineer, Engineering , Houston, Texas