Senior Systems Engineer
4 weeks ago
Job Summary:
Digital Prospectors is seeking a highly skilled Senior Systems Engineer to lead the development and implementation of projects focused on class II devices and accessories. The ideal candidate will excel in translating marketing requirements into precise product specifications, managing complex subsystem integration, and ensuring compliance with rigorous regulatory standards.
Key Responsibilities:
- Lead system architecture development and support software architecture definition.
- Translate marketing requirements into product requirements and design specifications.
- Develop and maintain system requirements specifications with emphasis on subsystem interfaces.
- Interface with industrial design companies and contract manufacturers.
- Manage technical project schedules, system integration roadmaps, and test schedules.
- Oversee integration and implementation of complex subsystems across multiple product families.
- Participate as a subject matter expert in cross-product family reviews as a system architect.
- Manage requirements engineering process and design reviews for product family.
- Facilitate technical direction and brainstorming within the R&D team.
- Demonstrate proficiency in compliance design controls and regulatory requirements.
- Utilize analytical models to describe system and subsystem behavior and interactions.
- Perform operational tests and fault isolation on systems and equipment.
- Prepare for and participate in comprehensive design reviews using various test and diagnostic equipment.
Requirements:
- Bachelor's degree in Electrical, Mechanical, Optical, or Computer Engineering, or equivalent experience (Master's degree is preferred).
- 15+ years of experience in systems engineering of complex medical devices.
- Advanced knowledge of FDA, IEC, and UL standards related to medical devices.
- Familiarity with DFx and lean manufacturing concepts.
- Experience in defining system architectures and performing system analysis.
- Experience in defining and developing system verification and validation test plans.
- Excellent problem-solving, organizational, verbal, and written communication skills.
- Ability to provide technical leadership on projects.
- Strong technical and analytical abilities including DOE and statistical analysis.
- Proficiency in Microsoft Project and/or Smartsheet.
- Experience with LabVIEW, Test Complete, AutoIT, or other automation tools.
- Familiarity with statistical modeling packages (i.e., Mathcad, MATLAB, Minitab, Excel).
- Familiarity with high-power laser products, optical modeling, fluid dynamics, and heat transfer is a plus.
- Six Sigma knowledge is advantageous.
What We Offer:
- Competitive salary and benefits package.
- Opportunity to work with a dynamic and innovative team.
- Professional development and growth opportunities.
- Recognition and rewards for outstanding performance.
How to Apply:
Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you
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