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Senior Engineer I - Mechatronics

US-Lawndale

Overview

The Senior Engineer I - Mechatronics provides advanced technical leadership and strategic guidance to multi-functional teams in design and development of complex trauma medical device systems and subsystems. The Senior Engineer leads all aspects of the device development process and lifecycle, including technology roadmap planning, advanced system architecture design, cross-functional team leadership, and mentoring of junior engineering staff. This includes managing complex projects, leading cost benefit analysis and optimization initiatives, advanced prototyping and testing methodologies, and driving innovation from early concept through design refinement, process development, and post-market activities.

This position involves advanced tasks such as system-level electro-mechanical design, control architecture development, advanced simulation and modeling, comprehensive test strategy development and data analysis; utilizing advanced CAD, simulation, and statistical analysis software to create, optimize, and validate complex designs. This position requires hands-on leadership in advanced prototyping and process development, qualification of complex equipment and systems, verification and validation strategy development and execution. Leading cross-functional laboratory teams, maintenance of Design History Files and Quality System documentation, and leadership in Risk Assessment and Risk Management processes across multiple projects.

This job is well suited to experienced professionals who can lead  and contribute to innovation teams, conceptualize, architect and build complex mechatronic systems for trauma medical devices, and drive strategic technology decisions. This individual is able to work independently, provide effective program management across multiple projects, and mentor junior engineering staff. This person should have deep expertise and leadership experience in research and development, design, test, and manufacturing in mechanical, electrical, and software engineering fields. This individual should also demonstrate excellent leadership, communication, technical writing, strategic thinking, and program management skills.

This is an on-site, full-time position.

The Senior Engineer - Mechatronics will provide strategic technical leadership and support to device development activities as assigned at the discretion of management.

Reports to:

VP of Production & Engineering

Duties and Responsibilities:

The Senior Engineer I - Mechatronics responsibilities typically involve:

  • Lead and architect the development of complex electro-mechanical systems, automated control platforms, and integrated medical device ecosystems to support advanced trauma care applications, manufacturing optimization, and next-generation packaging processes.
  • Lead and contribute to cross-functional teams in advanced lab and bench-top testing programs. Architect, build, and validate complex mechatronic system designs through advanced CAD modeling, multi-physics simulation, and sophisticated prototyping methodologies, perform comprehensive system evaluations, and lead completion of device design to facilitate seamless transfer to manufacturing (Good Manufacturing Practices).
  • Lead strategic coordination across engineering disciplines to analyze and perform comprehensive assessment of mechatronic systems for verification and validation activities. Architect and lead the coordination of complex device and product testing programs, develop advanced technical protocols (Good Document Practices) and comprehensive reports, including statistical data analysis and advanced control system performance optimization.
  • Drive innovation and ideate breakthrough concepts to develop next-generation mechatronic components, subassemblies and control technologies for advanced functionality across all trauma device development programs.
  • Lead design and implementation of advanced PLC programming, sophisticated HMI interfaces, complex embedded control systems, and robotic automation platforms for critical medical device applications.
  • Conduct advanced FEA, CFD, and multi-physics system simulation for novel mechatronic components and integrated systems, including functional safety analysis.
  • Lead development of comprehensive engineering documentation including production drawings, electrical schematics, control system architecture, and advanced system integration documentation.
  • Drive collaborative development of innovative production techniques and advanced manufacturing processes across all stages of complex mechatronic device development.
  • Lead maintenance of project documentation across multiple programs, including Standard Operating Procedures, Design Control Documentation, Design History Files, Quality System Documentation, and Risk Management Documents in compliance with FDA regulations and ISO standards.
  • Mentor and provide technical leadership to junior engineering staff, including recruitment, training, and professional development activities.
  • Represent the company at technical conferences, workshops, and industry events to maintain awareness of emerging technologies and establish strategic partnerships.
  • Lead technology roadmap development and strategic planning for mechatronic systems and platform development.
  • Perform all documented work in compliance with ISO 13485:2016, ISO 14971, IEC 62304, and FDA's Quality System Regulations.

Skills and Experience:

The Senior Engineer I - Mechatronics should be able to utilize and lead development of advanced skills and experience to drive innovative solutions for complex integrated electro-mechanical systems; lead selection and application of advanced test equipment and methodologies and resolve complex technical challenges that arise during performance of duties and responsibilities. The following abilities may aid the Senior Engineer - Mechatronics in completion of these tasks:

  • Expert proficiency with advanced CAD (SolidWorks, CATIA) and simulation software (MATLAB/Simulink, ANSYS Workbench) for creating, optimizing, and validating complex mechatronic systems and components.
  • Expert proficiency in multiple programming languages including Python, C/C++, LabVIEW, and MATLAB for advanced control system development, data analytics, and system integration.
  • Expert proficiency in PCB design, complex embedded systems, sensor fusion, advanced actuators, robotic control algorithms, and sophisticated electronic system integration.
  • Advanced proficiency in PLC programming, HMI development, SCADA systems, and complex industrial automation architectures.
  • Advanced proficiency in advanced simulation techniques (multi-physics FEA, CFD, controls modeling) and system optimization methodologies.
  • Ability to apply advanced mechanical, electrical, control theory, and systems engineering principles to architect and optimize complex designs and models.
  • Expert experience with advanced metrology equipment, automated test systems, and comprehensive system validation methodologies.
  • Deep knowledge of medical device manufacturing techniques, regulatory requirements (FDA 21 CFR Part 820, ISO 13485, IEC 62304), and functional safety standards.
  • Comprehensive knowledge of biocompatibility requirements, sterilization processes, and advanced packaging solutions for medical devices.
  • Advanced problem-solving and leadership abilities to resolve complex technical challenges and lead cross-functional teams through difficult development programs.
  • Strong technical leadership and mentoring skills to develop junior engineering talent and drive team performance.
  • Exceptional math and advanced engineering skills to perform complex calculations, statistical analysis, and system optimization.
  • Self-motivated with strong program management skills to ensure completion of multiple complex projects within demanding timelines.
  • Highly organized with exceptional attention to detail required for regulated medical device development across multiple product lines.
  • Excellent leadership and communication skills for cross-functional collaboration with clinical, regulatory, and executive teams.
  • Proven ability to lead and inspire cross-functional collaborative teams in fast-paced development environments.
  • Advanced proficiency with Microsoft Office Suite, project management software (MS Project, JIRA), and data analysis tools.
  • Must be able to lift 50 lbs.

Preferred Education and Training:

  • Bachelors or Master's Degree in Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, or related field.
  • 5-7 years experience in mechatronic system design and development, with significant experience in medical device or highly regulated industry, including robotic system development and deployment.
  • 5-7 years demonstrated success in complex control system programming, robotic system integration, and automation implementation.
  • 5-7 years of experience leading integrated electro-mechanical system development teams and advanced testing programs.

Preferred but not required:

  • Extensive experience with medical device regulatory processes, FDA Design Controls, and regulatory submissions.
  • Advanced experience with tolerance stack-up analysis software (e.g. Cetol) and statistical process control.
  • Deep knowledge of wireless communications, IoT applications, and connectivity solutions in medical devices.
  • Extensive experience with robotic systems, surgical automation platforms, medical robotics, or advanced medical device systems.
  • Professional Engineer (PE) license.
  • Published technical papers or patents in mechatronics or medical device fields.
  • Experience with artificial intelligence, machine learning, or advanced data analytics applications.

Required:

Authorization to work in the United States indefinitely without restriction or sponsorship.

To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

Benefits:

  • 401(k) Safe Harbor Plan
  • Healthcare Insurance: Medical, Dental and Vision
  • Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance
  • Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave
  • Tuition Reimbursement Program
  • Performance Bonus
  • Flexible Schedule
  • Lunches, Snacks, Events

Schedule:
Monday to Friday

Salary
$100,000 - $140,000 per year

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