Project Engineer

SUMMARY:

IRRAS is actively in the midst of globally launching the IRRAflow®product and numerous supporting accessories.  These products are currently all developed by design partners and manufactured at Contract Manufacturing Organizations (CMOs). IRRAS requires a Project Engineer who, working under minimal supervision and from corporate objectives, will work with the voice of customer and translate unmet user needs into improvements and new designs associated with electromechanical capital equipment and disposable devices that provide solutions to our customers in neuro critical care.

The Project Engineer shall report to the Director of Project Engineering and is a subject matter expert for all designs associated with the medical device disposables.  This position is a member of the global IRRAS Engineering Team and is expected to accelerate the IRRAS’ organic growth and make a significant positive impact on the performance and manufacturability of IRRAS’ products.  The ideal candidate will have experience in medical grade materials, catheters, 3D modeling, engineering experiments including DOEs, statistical analysis, process development, root cause analysis and applying clinical relevance to mechanical and electromechanical designs. The candidate will also have experience with engineering best practices to ensure product reliability, optimal yield and minimal cost for manufacturing.

ESSENTIAL FUNCTIONS:

  • Based on voice of customer, develops and transfers to manufacturing medical device disposables (e.g. catheters and cranial access devices) to reduce complaints and cost, improve manufacturability, and provide enhanced value
  • Conducts user feasibility and advanced studies to characterize performance and reliability
  • Creates detailed engineering drawings based on advanced 3D modeling components and assemblies
  • Authors and drives the cross-functional creation of medical device technical design control and Design History File (DHF) deliverables, e.g. Trace Matrices, Failure Modes & Effect Analysis, test protocols and reports, and technical files
  • Collaborates with vendors to develop and improve products
  • Technically supports field Sales Staff and Marketing
  • Authors intellectual property relative to novel inventions
  • Manages simple and complex product development projects that adhere to a structured design control process
  • Plans and organizes work assignments with minimal supervision
  • Provides technical mentoring to junior engineers, technicians, and interns
  • Leads critical root cause analysis relative to production failures and field complaints
  • Maintains records as per company standards
  • Demonstrates disciplined orientation toward a structured engineering change process
  • Demonstrates responsible for the safety of employees and the maintenance of a hazard free workplace

EDUCATION/EXPERIENCE REQUIRED:

  • BS in mechanical engineering or biomedical engineering
  • 3-7 years of demonstrated “hands-on” experience in design and/or manufacturing engineering positions of increasing responsibility in a medical device regulated environment
  • Advanced knowledge of federal and other regulations governing FDA cleared and CE Mark certified medical device design and manufacturing, e.g. cGMP, Quality Management System (QMS), ISO 13485, IEC 60601, Medical Device Regulation/Directive (MDR/MDD)

REQUIRED SKILLS:

  • Identifies key trade-off risks and is able to make technical decisions to challenging matters
  • Experience with metrology methodologies and fixture design
  • Effective working knowledge of Product Data or Product Lifecycle Management (PDM or PLM) process and tools
  • Hands on experience with engineering analysis tools, representing a wide range of instruments for testing hydraulic valves, plastic & electro-mechanical assemblies under a variety of stress conditions that test pressure, temperature, flow, humidity, stress, creep, EMI, power, life cycle, reliability, etc
  • Electro-mechanical and plastic part incoming and in process quality inspection, i.e. gauges, fixtures, CMM, laser or other non-contact systems, and material composition analysis
  • Strong administrative skills including computer proficiency in Microsoft Project, Word, Excel, PowerPoint, and Visio.  Equally strength in technical applications such as 3D modeling, product configuration management, and analytical analysis
  • Design and manufacturing experience with electro-mechanical pump and catheters systems is a plus
  • Collaboration with key opinion leaders and clinical workflow
  • A Six Sigma Green or Black Belt
  • Fluent in SolidWorks
  • High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
  • Excellent communications and presentation skills
  • Ability to develop and manage a high-performance team focused on accountability and meeting and exceeding expectations
  • Ability to lead, influence, create and work within cross-functional team environments
  • Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done

REQUIRED COMPETENCIES:

  • Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments
  • Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives
  • Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry
  • Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance
  • Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty
  • Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks
  • Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit
  • The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often
  • Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
  • The employee might occasionally lift and/or move up to 25 pounds

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • General office environment
  • Daily exposure to PCs and networks
  • The noise level in the work environment is usually moderate
  • Travel might be required

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

If you are interested in applying for employment with IRRAS please apply here

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