Principal System Engineer

2 months ago

Marlborough, United States Candela Medical Full time

General Summary

The Senior/Principal Systems Engineer will work across engineering functions to implement projects related to aesthetic laser systems and accessories. This person will work cross functionally (marketing, clinical, service, manufacturing, regulatory, and quality organizations) to define, architect, and coordinate the implementation of engineering tasks of projects related to aesthetic laser systems and accessories. In addition, this role will translate marketing requirements into product requirements as well as bridging to design specifications. As part of this responsibility the senior/principal systems engineer will develop and maintain the system requirements specification for the project with emphasis on subsystem interfaces.


Essential Job Functions

· Accountable for system architecture and supports software architecture definition.

· Supports the creation of the design concepts and initial feasibility.

· Provides interface to industrial design companies and contract manufacturers for the development/PEO teams

· Primary interface into Engineering for projects

· Capable of rightsizing projects based on complexity.

· Works closely with functional leads in their respective fields to develop detailed design specifications. HwRS, SwRS, GUI specifications, Usability specifications, and Human Factors.

· Is accountable for design inputs and outputs and works closely with the V&V project-leads to establish test and traceability strategies.

· Knowledge of automation tools to support system product automation related to life testing (Labview, test complete, autoIT, etc)

· Familiar with requirements management tools. (DOORS, JAMA, etc)

· Is accountable for overseeing the integration and implementation of varying degrees of complexity across multiple product families (involving optics, RF energy, mechanical, electrical and software)

· Establishes test criteria and can execute testing for system level requirements and works with PQ(V&V) and Development to ensure test coverage of high level and low-level requirements.

· Is a subject matter expert and participates in cross product family reviews as a system architect.

· Is a member of the core cross functional team representing system engineering/R&D

· Manages technical project schedules (including Gantts, system integration roadmaps, and test schedules)

· Manages the requirements engineering process (including elicitation, development, and maintenance) as well as design reviews for his/her product family.

· Is accountable for the establishment and maintenance of system level engineering documentation (such as PRD)

· Facilitates technical direction and brainstorming with remaining R&D team.

· Debugs and characterizes defects, providing detailed configuration and descriptions for passing and failing tests for product evaluation reports.

· Knowledgeable of compliance design controls and all regulatory requirements.

· Ability to develop and document analytical models of system and subsystem behavior and interactions.

· Work with the PM to define and maintain system integration activities within the project.

Works from schematics, diagrams, written and verbal descriptions, layouts, or defined plans to perform testing, checkout and trouble-shooting functions.

· Performs operational test and fault isolation on systems and equipment.

· Assists in determining methods or actions to remedy malfunctions.

· Prepare for and participate in comprehensive design reviews.

· Uses manufacturing, test, development, or diagnostic equipment, including, but not limited to, test programs, oscilloscopes, signal generators and specialized test apparatus.


Knowledge/Educational Requirements

· BS or MS (preferred) in electrical, mechanical, optical, or computer engineering or 15 years of equivalent experience

· Minimum of 15 plus years of related experience in systems engineering of complex medical devices

· Advanced knowledge of FDA, IEC and UL standards relating to medical devices

· Familiar with DFx and lean manufacturing concepts

· Define and develop system architectures and perform system analysis.

· Define and develop system verification and validation test plans.


Skills and Abilities

· Excellent interpersonal, organizational as well as verbal and written communication skills

· Provide technical leadership on projects.

· Strong technical and analytical abilities including DOE, and statistical analysis.

· Strong problem-solving skills.

· Good level familiarity with MS Project and/or Smartsheet

· Familiarity with requirements tools

· Familiarity with Labview, Test Complete, AutoIT or other automation tools

· Familiarity with statistical modeling packages (MathCAD, Matlab, Minitab, Excel)

· Familiarity with high power laser products desirable

· Familiarity with optical modeling, fluid dynamics, heat transfer desirable

· Six sigma knowledge is an advantage.

· Familiarity with DF'x and lean manufacturing concepts



This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.

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