Lead Systems Architect

1 week ago

Marlborough, Massachusetts, United States Candela Medical Full time

Overview

The Senior/Principal Systems Engineer at Candela Medical will collaborate across various engineering disciplines to drive projects focused on aesthetic laser technologies and their associated components. This role involves working cross-functionally with teams in marketing, clinical, service, manufacturing, regulatory, and quality to define, design, and oversee the execution of engineering tasks related to aesthetic laser systems and accessories. Additionally, this position will convert marketing needs into product specifications while ensuring alignment with design criteria. The Senior/Principal Systems Engineer will also be responsible for developing and maintaining the system requirements documentation, with a strong focus on subsystem interactions.

Key Responsibilities

· Responsible for the system architecture and assists in defining software architecture.

· Aids in the creation of design concepts and initial feasibility assessments.

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

· Serves as the main engineering contact for project-related inquiries.

· Capable of adjusting project scopes based on complexity.

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

· Responsible for design inputs and outputs, working alongside V&V project leads to establish testing and traceability strategies.

· Proficient in automation tools that support system product automation for life testing (e.g., Labview, TestComplete, AutoIT).

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

· Oversees the integration and implementation of varying complexities across multiple product lines, encompassing optics, RF energy, mechanical, electrical, and software components.

· Establishes testing criteria and executes system-level requirement tests, collaborating with PQ(V&V) and Development to ensure comprehensive test coverage.

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

· Member of the core cross-functional team representing systems engineering and R&D.

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

· Oversees the requirements engineering process, including elicitation, development, and maintenance, as well as design reviews for the respective product family.

· Responsible for the establishment and upkeep of system-level engineering documentation (e.g., Product Requirement Documents).

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

· Diagnoses and characterizes defects, providing detailed configurations and descriptions for both successful and unsuccessful tests for product evaluation reports.

· Knowledgeable about compliance design controls and all relevant 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.

· Assists in identifying 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

· Bachelor’s or Master’s degree (preferred) in electrical, mechanical, optical, or computer engineering, or 15 years of equivalent experience.

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

· Advanced understanding 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.

· Capability to define and develop 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 automation tools such as Labview, TestComplete, AutoIT.

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

· Experience with high-power laser products is desirable.

· Knowledge of optical modeling, fluid dynamics, and heat transfer is advantageous.

· Six Sigma knowledge is a plus.

· Familiarity with DFx and lean manufacturing concepts.

This job description is intended to capture the primary responsibilities and qualifications for the role. Additional tasks and projects may be assigned by management as needed.

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