Job Title: Senior Controls Engineer 

Company Overview:
They are a leading medical device consulting firm dedicated to advancing healthcare through innovative solutions and regulatory compliance. Their team of experts collaborates with medical device companies to design, develop, and optimize cutting-edge technologies that improve patient outcomes worldwide.

Location:
Greater Boston, area
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Job Description:
Our client is seeking a highly skilled Senior Controls Engineer with extensive experience in medical device development to join their dynamic team. As a Senior Controls Engineer, you will lead and contribute to the design and implementation of control systems for a variety of medical devices, ensuring compliance with regulatory standards and industry best practices.

Required Skills & Experience
· Education: Bachelor's degree in Electrical Engineering, Computer Engineering, or a related field. Advanced degree (Masters or Ph.D.) preferred.
· Experience: Minimum of 7 years of experience in control systems engineering, with at least 3 years in the medical device industry or a regulated environment.
· Technical Skills: Proficiency in control system design, including PID control, state-space models, and digital signal processing. Experience with MATLAB/Simulink, LabVIEW, or similar tools.
· Regulatory Knowledge: Familiarity with FDA regulations, ISO standards, and medical device development processes (Design Controls, Risk Management).
· Communication Skills: Excellent verbal and written communication skills. Ability to effectively collaborate with clients, stakeholders, and cross-functional teams.
· Problem-Solving Ability: Strong analytical and problem-solving skills, with a meticulous attention to detail. Ability to troubleshoot and resolve complex technical issues.
· Project Management: Experience leading technical projects from concept through commercialization. PMP certification or project management experience is a plus. What You Will Be Doing
Tech Breakdown c/c++ Daily Responsibilities
· Control System Design: Lead the design, development, and integration of control systems for medical devices, including specification, architecture, and implementation.
· Algorithm Development: Develop and optimize algorithms for real-time control, signal processing, and data analysis in medical device applications.
· Hardware-Software Integration: Collaborate with hardware engineers and software developers to integrate control algorithms into embedded systems and ensure seamless operation.
· Verification and Validation: Design and execute verification and validation tests to ensure control system performance meets functional and regulatory requirements.
· Regulatory Compliance: Ensure control system designs and documentation comply with FDA regulations, international standards (ISO 13485, IEC 60601), and other relevant guidelines.
· Risk Management: Conduct risk assessments related to control systems and contribute to risk management activities throughout the product development lifecycle.
· Documentation and Reporting: Prepare technical documentation, including design specifications, test protocols, and reports. Present findings and recommendations to clients and project stakeholders.
· Team Leadership: Provide technical leadership and mentorship to junior engineers. Collaborate effectively with multidisciplinary teams to achieve project milestones and deliverables.
The Offer Bonus OR Commission eligible You will receive the following benefits: Medical, Dental, and Vision Insurance Vacation Time Stock Options