Senior Project Engineer - Hardware Job at CSG in Miami

Senior Project Engineer - Hardware
Our Client * Miami, FL * via LinkedIn
Full-time | Paid time off | Dental & Health Insurance

Job Overview
Our client is seeking a Senior Project Engineer with a focus on hardware to contribute to the development of next-generation surgical robots. In this role, you will manage and coordinate hardware-related projects from inception to completion, ensuring adherence to quality standards, timelines, and budgets.

Key Responsibilities

• Lead hardware-focused projects for the development of advanced surgical robots, ensuring alignment with the company's design and quality standards.
• Coordinate key project aspects such as requirement gathering, risk analysis, document deliverables, verification, validation, and design transfer.
• Maintain design plans and ensure all projects follow design controls in compliance with company SOPs.
• Conduct quality control throughout project development to meet industry standards.
• Facilitate cross-functional collaboration to ensure project objectives are met.
• Support planning and execution of verification and validation activities.
• Keep a comprehensive overview of project status and provide regular updates to the leadership team.
• Present data and insights to assist leadership in decision-making during critical project stages.
• Serve as a liaison between R&D, Manufacturing, and Quality teams to ensure smooth project progression.
• Interact with teams across Product Management, Marketing, Sales, Quality, and customers to gather feedback on new product designs and improvements.
• Collect and review field data to support timely technical investigations by the engineering team.
• Help generate key project deliverables including Design Inputs, Design Outputs, Risk Analysis, Trace Matrices, etc.
• Collaborate with engineering and quality teams to drive FMEA development.
• Identify and address gaps between user requirements and system requirements, ensuring proper alignment.
• Contribute to refining requirements definitions and developing test plans for verification and validation.
• Track project performance, identifying areas for improvement.
• Travel up to 10% of the time for off-site work and overnight stays.

Qualifications

• Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical, or related field) with 4+ years of project management experience, or a Master's degree with 3+ years of relevant experience.
• In-depth knowledge of ISO 13485, 21 CFR 820, and IEC 60601.
• Strong communication and interpersonal skills.
• Proficiency in project management software and methodologies.
• Demonstrated ability to manage projects from start to finish, ensuring they are completed within scope, budget, and timeline.
• Experience with hardware engineering and design processes, including design controls and quality management systems.

Benefits

• Innovative and collaborative work environment.
• Opportunity to make an immediate impact in life-changing technology.
• No siloed work culture in a fast-paced, startup environment.
• Generous benefits including sabbatical, parental leave, and unlimited PTO.
• Competitive 401K plan with 4% company match.
• Comprehensive medical, dental, and vision insurance.

Work Environment

• Occasional exposure to moderate noise levels.
• Regular use of project management software.
• Occasional travel outside the local area (up to 10%).

Accommodation

• Reasonable accommodations will be provided for individuals with disabilities to perform essential job functions.