Senior Manufacturing Engineer

SUMMARY:

The Sr. Manufacturing Engineer shall report to the Manufacturing Engineering Leader and is a subject matter expert for all electromechanical designs associated with the products.  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 electrical theory, PCB design and troubleshooting methodology medical grade materials, 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.  A background in lean manufacturing and implementation of lean principals is required.

ESSENTIAL FUNCTIONS:

  • Prototyping, developing and improving designs based on voice of customer, complaint reduction, manufacturability and cost optimization.
  • Conducts feasibility and advanced studies to characterize performance and reliability
  • Creates detailed engineering drawings based on advanced 3D modeling components and assemblies
  • Collaborates with vendors to develop and improve production lines
  • Author intellectual property relative to the technology roadmap
  • Manage simple and complex product development projects that adhere design controls, deliver technical deliverables, and minimize cost of goods sold
  • Plans and organizes work assignments with minimal supervision
  • Provide technical mentoring to junior engineers and technicians
  • Lead critical root cause analysis relative to product complaint investigations
  • Experience with metrology methodologies and fixture design
  • Identifies key trade-off risks and is able to make technical decisions to challenging matters
  • Effective working knowledge of Product Data or Product Lifecycle Management (PDM or PLM), Enterprise Requirements Planning (ERP), and Material Requirements Planning (MRP) systems
  • 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
  • Maintains records as per company standards
  • Disciplined orientation toward a structured engineering change process
  • Responsible for the safety of employees and the maintenance of a hazard free workplace
  • Neat, Methodical, Organized
  • Knowledge of Lean Manufacturing principals with the ability to deploy in startup manufacturing environment

EDUCATION & EXPERIENCE:

  • BS in engineering discipline
  • 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 medical device design and manufacturing, e.g. cGMP, QMS, ISO 13485, IEC 60601

REQUIRED SKILLS:

  • Design and manufacturing experience with electro-mechanical pump and catheters systems is a plus.
  • Collaboration with key opinion leaders and clinical workflow
  • Kaizen and/or Lean Manufacturing Certifications
  • A Six Sigma Green or Black Belt
  • Fluent in SolidWorks

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 20 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.

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