Advanced Engineer III

Millar, Inc Located in: Houston,  Texas
(Private and Secure - Guaranteed!)

Millar, Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Come be a part of a dynamic team that is helping to make the improbable possible through innovation, customer relationships and support of our novel catheter-based, pressure sensing and telemetry technology, which is utilized worldwide in medical research, diagnostics and clinical treatment.

Millar works directly with customer and business partners to help push medical discovery to the next level.  From mouse to man, our company plays an important role in medical discovery at every level.  Join Millar during an exciting period of growth, as we take the opportunity to expand our clinical and research markets and leave a lasting impact on the medical community.

The Advanced Engineer will be involved in improving existing product lines and developing new products through the evaluation and application of novel ideas, mechanical engineering concepts and new technology. Considerable attention is given to research, design, manufacturing, testing, calibration, procurement and operations.

Essential Responsibilities & Duties:

  • Lead a cross departmental team to complete projects as assigned by management
  • Plan, schedule, and complete assigned projects in a timely manner consistent with corporate objectives, current Good Manufacturing Practices (GMP), and in adherence with all FDA and ISO requirements
  • Determine and establish project requirements, specifications, and guidelines through engineering research, calculations, and layouts
  • Prepare product specification documents, cost estimates, reports, proposals, and presentations
  • Create design drawings, material analysis, schematics, and tolerance computations
  • Plan, prepare, and conduct engineering studies to support equipment, process, and parts selection decisions
  • Compose V&V test protocols, memos, reports, and technical procedure manuals
  • Participate in and/or host design reviews using design control guidelines Perform design of new catheters or design enhancement(s) to existing catheter product line
  • Perform design or modification of catheter fabrication or test equipment used for production
  • Act as a mentor to junior engineers or technicians
  • Communicate with manufacturing personnel to solicit input for new and existing product designs
  • Identify and implement product and process improvements
  • Draft process validation protocols and conduct process validations
  • Perform root cause analysis and resolve manufacturing, and product related issues
  • Other duties as assigned by Engineering Management.

CRITICAL REQUIREMENTS


    •         
    • Bachelor’s Degree in Mechanical, Engineering or equivalent from a four-year college or university

    •         
    • Minimum of 10+ years engineering experience, preferably in the medical device or other regulated industry, with at least 2 years of experience managing an engineering team.

    •         
    • Software knowledge: MS Office Suite, MiniTab, SolidWorks, AutoCAD

    •         
    • Knowledge of developing a product from concept to full production release, especially relating to catheter products is a plus.

    •         
    • Knowledge of 21 CFR Part 820, ISO-13485, AAMI BP-22, AAMI NS-28 is a plus

    •         
    • Experience conducting Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) is a plus

    •         
    • Essential skill set includes comprehensive mechanical engineering design skill for device, system and process design. Catheter device design will be a primary function of this position.

    •         
    • Essential skill sets include strong project management for successful execution from beginning to end, the ability to lead cross-departmental teams and the capability to deliver projects on time and in budget.

    •         
    • Must be able to communicate and negotiate effectively with project stakeholders, as well as demonstrate tactical and strategic planning skills. Project management and leadership is essential.

COMPANY INFORMATION

Millar, Inc. provides innovative physiological monitoring solutions to the medical science community that offer insight by delivering unparalleled accuracy. Our expertise in novel device design, manufacturing and depth of understanding of customers’ applications enables us to provide tools for facilitating scientific discovery and medical diagnosis. With our proven Mikro-Tip® pressure and pressure-volume catheter lines, our pressure-volume (PV) loop systems and revolutionary wireless implantable animal telemetry system, we strive to provide clinicians and researchers with the most exact physiological solutions for complete insight from mouse to man.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Engineering
Preferred Industry Background:
  Medical Device,  Biotechnology,  Research
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
Education Required:
Any
Therapeutic Experience:
Cardiovascular
International Experience:
North America