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Lead Systems Architect

2 months ago

Marlborough, Massachusetts, United States Candela Medical Full time

Overview

The Senior/Principal Systems Engineer will collaborate across various engineering disciplines to execute projects associated with aesthetic laser technologies and their components. This individual will engage cross-departmentally (including marketing, clinical, service, manufacturing, regulatory, and quality teams) to outline, design, and synchronize the execution of engineering responsibilities for projects related to aesthetic laser technologies and their components. Additionally, this role will convert marketing needs into product specifications while ensuring alignment with design criteria. As part of this duty, the Senior/Principal Systems Engineer will formulate and uphold the system requirements documentation for the project, focusing on subsystem interactions.

Key Responsibilities

· Responsible for system architecture and aids in defining software architecture.

· Assists in the development of design concepts and initial feasibility assessments.

· Acts as the primary liaison to industrial design firms and contract manufacturers for development teams.

· Serves as the main point of contact within Engineering for projects.

· Capable of adjusting project scopes based on complexity.

· Collaborates closely with functional leaders to create detailed design specifications, including Hardware Requirements Specifications (HwRS), Software Requirements Specifications (SwRS), Graphical User Interface (GUI) specifications, usability criteria, and human factors considerations.

· Accountable for design inputs and outputs, working in tandem with V&V project leads to establish testing and traceability strategies.

· Proficient in automation tools to facilitate system product automation related to life testing (e.g., Labview, TestComplete, AutoIT).

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

· Responsible for overseeing the integration and implementation of varying complexities across multiple product lines (involving optics, RF energy, mechanical, electrical, and software components).

· Establishes testing criteria and executes testing for system-level requirements, collaborating with PQ(V&V) and Development to ensure comprehensive test coverage of both high-level and low-level requirements.

· Acts as a subject matter expert and participates in cross-product family reviews as a systems architect.

· Represents system engineering/R&D as a member of the core cross-functional team.

· Manages technical project timelines (including Gantt charts, system integration roadmaps, and testing schedules).

· Oversees the requirements engineering process (including elicitation, development, and maintenance) and design reviews for their product family.

· Responsible for the establishment and upkeep of system-level engineering documentation (such as Product Requirement Documents).

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

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

· Knowledgeable about compliance design controls and all regulatory requirements.

· Capable of developing and documenting analytical models of system and subsystem behaviors and interactions.

· Collaborates with the Project Manager to define and maintain system integration activities within the project.

· Works from schematics, diagrams, written and verbal descriptions, layouts, or defined plans to conduct testing, checkout, and troubleshooting functions.

· Conducts operational tests and fault isolation on systems and equipment.

· Aids in determining methods or actions to resolve malfunctions.

· Prepares for and participates in comprehensive design reviews.

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

Qualifications

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

· A minimum of 15 years of relevant experience in systems engineering for complex medical devices.

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

· Familiarity with DFx and lean manufacturing principles.

· Ability to define and develop system architectures and perform system analyses.

· Experience in defining and developing system verification and validation test plans.

Skills and Competencies

· Exceptional interpersonal, organizational, and communication skills, both verbal and written.

· Provides technical leadership on projects.

· Strong technical and analytical skills, including Design of Experiments (DOE) and statistical analysis.

· Excellent problem-solving abilities.

· Proficient in MS Project and/or Smartsheet.

· Familiarity with requirements management tools.

· Knowledge of Labview, TestComplete, AutoIT, or other automation tools.

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

· Experience with high-power laser products is desirable.

· Familiarity with optical modeling, fluid dynamics, and heat transfer is advantageous.

· Six Sigma knowledge is a plus.

· Understanding of DFx and lean manufacturing concepts.

This job description is not exhaustive and is intended to encompass the majority of the job functions. Additional projects and tasks may be assigned by management.