This position operates under only modest supervision.
Key Duties and Responsibilities:
- 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
- Have an intermediate competency in design and use of engineering systems and
- 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
- 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
- Maintains accurate lab notes (i.e. lab notebooks).
- Other duties may be assigned.
- Must be able to interface well with others, especially Manufacturing
- 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
- Develop systems for monitoring manufacturing quality. Recommends and
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
- 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
- Lead the non-conforming material process and participate in or lead the
Materials Review Board
- Proactively investigates, identifies, and implements best-in-class Quality
- 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
- Applicable Production Equipment
- Applicable Software Packages
- Appropriate tools, as necessary.
- Typical experience required is a minimum of 3 years as an Engineer in the
- Four-year degree required, preferably in Engineering.
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