Quality Engineer II
Spectranetics 13 reviews - Colorado Springs, CO

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This position operates under only modest supervision.
  • This position requires intermediate level engineer experience where the Engineer II performs and is responsible for most duties involved in specific projects or assignments.

  • All development of processes and systems should maintain a focus on safety and ergonomics and be in accordance with all established safety codes, polices and government guidelines. Carry out all assignments in a safe and efficient manner.

  • Have an intermediate competency in design and use of engineering systems and tools.

  • Have a basic understanding of FDA and ISO 13485 requirements and effective implementation of these concepts through all verification and validation activities relating to medical device regulations is required.

  • Develop clear and well understood documentation for engineering changes, which may include, but is not limited to protocols, reports, deviations, drawings, and documentation for acquisition of capital equipment.

  • Initiate, design, optimize, and development of robust processes. The expected outcome should result in an accurate and complete process validation. (i.e. IQ, OQ,PQ).

  • Successfully manage the development of scope, schedule and budget for new projects from concept through implementation for smaller projects (= $25,000).

  • Design and implement processes where only general requirements and constraints provided. This may include sub-assembly, final assembly and packaging equipment design.Complex or novel designs may require assistance from more experienced engineers.

  • Incumbent maybe a part of a Product Development core team to support design control and new product launch initiatives.

  • Responsible for assisting with a smooth transition of new products introduced into manufacturing.

  • Demonstrate an understanding of lean principals and their application in a medical device industry.

  • Very proficient with CAD tools (SolidWorks preferred). Complex modeling may be required.

  • A basic understanding of statistics is required and incumbent must be proficient with the use of JMP for statistical analysis. Be able to capture, format and analyze data. This should include the ability to recognize errors or discrepancies in data and propose explanations for the discrepancies.

  • Provide technical resources across departments as business needs require.

  • Contribute toan environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results. Train less experienced personnel on established methods and procedures. Facilitate the transfer of technical knowledge, while demonstrating an understanding of those with a diverse background or experience.

  • Communicate fully with superiors and others who have a need to know. Be informative without being obtrusive or vexatious. Communicate in a way that is timely, yet prompt; complete, yet concise; candid, yet accurate; and clear, yet responsive.

  • Maintains accurate lab notes (i.e. lab notebooks).

  • Other duties may be assigned.

Key Duties and Responsibilities:
  • Must be able to interface well with others, especially Manufacturing Engineering.

  • Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.

  • Develop, implement and monitor quality metrics. Communicate status and progress.

  • Develop systems for monitoring manufacturing quality. Recommends and assists, as
    necessary, in the implementation of corrective/preventative actions.

  • Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.

  • Lead ands upport Health Hazard Analysis (HHAs) to ensure risk assessment and root cause analysis are consistent across products and systems.

  • Develop validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close

  • Participate in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and qualitytools.

  • Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.

  • Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.

  • Lead the non-conforming material process and participate in or lead the Materials Review Board

  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

  • Experienced in basic inspection and testing techniques; must be able to read and interpret blueprints.


May supervise a junior Engineer, technician or intern, as necessary.

Materialand Equipment Directly Used:
  • General measuring equipment such as calipers, micrometers, and tensile test equipment.

  • Computers

  • Applicable Production Equipment

  • Applicable Software Packages

  • Appropriate tools, as necessary.

Education/Experience Necessary:
  • Typical experience required is a minimum of 3 years as an Engineer in the related field.

  • Four-year degree required, preferably in Engineering.

About this company
13 reviews
The Spectranetics Corporation was founded in the 1980s on excimer laser technology and today markets the only Excimer Laser System approved...