Senior Controls Engineer
Boston, Massachusetts
Hybrid
Full Time
$140k - $180k
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
· 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
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
????
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++
· 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
- Medical, Dental, and Vision Insurance
- Vacation Time
- Stock Options