Current jobs related to Director, Systems Engineering - Boston, Massachusetts - Biofourmis

  • Validation Systems Engineer

    4 weeks ago

    Boston, Massachusetts, United States Trinity Consultants - Advent Engineering Full time

    CSV EngineerLocation: Boston/Rhode Island Key Responsibilities:Develop and implement documentation for Quality Systems aimed at establishing effective validation practices within the organization.Create User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Risk Assessments, Configuration Specifications, Design Specifications,...

  • Information Systems Solutions Engineer

    1 day ago

    Boston, Massachusetts, United States Information Systems Solutions Full time

    Information Systems Solutions is seeking a skilled Information System Engineer to join our team.About the Role:As an Information System Engineer at Information Systems Solutions, you will be responsible for designing, implementing, and maintaining our company's information systems.Key Responsibilities:* Design and develop secure and efficient information...

  • Lead Systems Planning Engineer

    4 hours ago

    Boston, Massachusetts, United States K&A Engineering Consulting PC Full time

    Job OverviewWe are seeking an experienced Lead Systems Planning Engineer to join our Grid Integration and Planning team in Boston, MA.ResponsibilitiesSupport projects by carrying out transmission analysis and working with interconnection interfaces in PJM, NYISO, and ISO-NE.Develop work products that provide sufficient decision-making information to...

  • Director of Engineering

    3 days ago

    Boston, Massachusetts, United States Fidelity Investments Full time

    Job DescriptionAt Fidelity Investments, we're seeking a seasoned Director of Engineering to lead our team in developing innovative solutions using cutting-edge technologies. As a key member of our Fidelity Labs team, you'll be responsible for designing, implementing, and delivering new products and capabilities that drive growth for our company.Key...

  • Director of Engineering

    2 days ago

    Boston, Massachusetts, United States Fidelity Investments Full time

    Director of EngineeringFidelity Investments is seeking a seasoned Director of Engineering to lead our team in developing innovative solutions using machine learning, large language models, and cloud-native architecture.As a hands-on player/coach, you will be responsible for designing, implementing, testing, and delivering new Catchlight products and...

  • Systems Engineer

    2 days ago

    Boston, Massachusetts, United States GelSight Full time

    About GelSightGelSight is a pioneering company at the forefront of revolutionizing machine intelligence through the digitization of touch. Our cutting-edge platform sits at the intersection of key trends in metrology and the digitization of tactile interactions.In an era where artificial intelligence strives to emulate human senses, GelSight is uniquely...

  • Employee Relations Consultant

    4 weeks ago

    Boston, Massachusetts, United States Connexion Systems & Engineering, Inc. Full time

    Job OverviewAt Connexion Systems & Engineering, we are dedicated to delivering exceptional staffing solutions. Our goal is to excel in job placement, recruitment, and staffing services while ensuring that candidates are treated with the utmost professionalism and respect.Position: Senior Employee Relations ConsultantHybrid Work Model: 3 days on-site per...

  • UPS Systems Specialist

    1 week ago

    Boston, Massachusetts, United States Clear Engineering Recruitment LTD Full time

    Job Title: UPS Service EngineerClear Engineering Recruitment LTD is seeking a skilled UPS Service Engineer to join our team. As a critical infrastructure technician, you will be responsible for commissioning, maintaining, and providing emergency support on power electronics at customers' sites.Key Responsibilities:Commission and maintain power electronics...

  • Director of Software Engineering

    1 week ago

    Boston, Massachusetts, United States Fidelity Investments Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Software Engineering to join our team at Fidelity Investments. As a key member of our engineering leadership team, you will be responsible for leading the development of new tools and features for our portfolio managers.As a Director of Software Engineering, you will be hands-on with...

  • Civil Engineering Project Director

    3 hours ago

    Boston, Massachusetts, United States TEC Group Inc. Full time

    Job Title: Civil Engineering Project DirectorTEC Group Inc. is seeking a highly experienced Civil Engineering Project Director to lead our construction projects in the Boston area.Key Responsibilities:Provide overall management direction for existing projects.Ensure achievement of project and budget targets.Secure business functionality to drive extensive...

  • Systems Engineering Lead

    6 days ago

    Boston, Massachusetts, United States Northeastern University Full time

    About the OpportunityThe Department of Electrical and Computer Engineering and the Ultrabroadband Nanonetworking Laboratory (UNLab) at Northeastern University are seeking a highly motivated and experienced Systems Engineer to lead the design, development, integration, and testing of the university's first CubeSat mission. The mission aims to demonstrate the...

  • Systems Engineering Trainee

    4 weeks ago

    Boston, Massachusetts, United States Schneider Electric Full time

    Schneider Electric is on the lookout for a Systems Engineering Trainee to join our innovative engineering team. This role offers a unique opportunity to gain practical experience in diagnosing and improving the performance of surveillance systems and managing security access controls. As a Systems Engineering Trainee, you will play a crucial role in...

  • Electrical Systems Engineer

    3 days ago

    Boston, Massachusetts, United States Motion Recruitment Full time

    Electrical Engineer - Robotics and AutomationWe are seeking a highly skilled Senior Electrical Engineer to join our team at Motion Recruitment. Our client is a leading innovator in the automotive industry, specializing in cutting-edge robotics solutions.About the RoleThis is an exciting opportunity to design, develop, and optimize electrical systems and...

  • Systems Engineering Intern

    4 weeks ago

    Boston, Massachusetts, United States Schneider Electric Full time

    Schneider Electric is on the lookout for a Systems Engineering Intern to join our innovative team. In this role, you will immerse yourself in a vibrant engineering environment, gaining practical experience in diagnosing and improving the performance of surveillance systems and managing security access solutions. This internship offers a unique chance to...

  • Electrical Systems Engineer

    6 days ago

    Boston, Massachusetts, United States WB Engineers+Consultants Full time

    Electrical Project EngineerAt WB Engineers+Consultants, we are seeking a highly skilled Electrical Project Engineer to join our team. As a key member of our engineering team, you will be responsible for the management and production of building infrastructure design systems.Key Responsibilities:Support the electrical and lighting design of systems from...

  • Principal Systems Engineer

    4 days ago

    Boston, Massachusetts, United States Medtronic Full time

    About the RoleWe are seeking a highly skilled Principal Systems Engineer to join our team at Medtronic. As a key member of our Systems Engineering Team, you will be responsible for leading and contributing to investigations and root causing of issues associated with the HugoTM Robotically Assisted Surgical System.Key ResponsibilitiesUnderstand, evaluate, and...

  • Power Systems Engineer

    3 days ago

    Boston, Massachusetts, United States Network Rail Consulting Full time

    About the RoleWe are seeking a highly skilled Power Systems Engineer to join our team at Network Rail Consulting. As a key member of our East Coast team, you will provide consultant advisory services in the field of traction power, overhead catenary/third rail systems, and electrification.Key ResponsibilitiesDirect support to clients in operational...

  • Senior Systems Engineer

    6 days ago

    Boston, Massachusetts, United States GelSight Full time

    About GelSightGelSight is a pioneering company at the forefront of machine intelligence, revolutionizing the digitization of touch and tactile interactions. Our platform sits at the intersection of key trends in metrology, 3D surface characterization, and the digitization of tactile perception.Job SummaryWe are seeking a highly skilled Systems Engineer to...

  • Clinical Systems Engineer

    4 days ago

    Boston, Massachusetts, United States Mass General Brigham Full time

    Job SummaryWe are seeking a highly skilled Clinical Systems Engineer to join our team at Mass General Brigham. As a key member of our healthcare IT team, you will be responsible for planning, evaluating, and implementing network technologies to enable medical device connectivity, integration, and interoperability.Key ResponsibilitiesConfigure, deploy,...

  • Power Systems Engineer

    4 days ago

    Boston, Massachusetts, United States Network Rail Consulting Full time

    About the OpportunityWe are seeking a highly skilled Power Systems Engineer to join our team at Network Rail Consulting in Boston, Massachusetts. As a key member of our East Coast team, you will provide consultant advisory services in the field of traction power, overhead catenary/third rail systems, and electrification.Key ResponsibilitiesSupport clients in...

Director, Systems Engineering

4 months ago

Boston, Massachusetts, United States Biofourmis Full time

Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials-all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care-ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Needham, MA and key offices in Singapore and India. Join our team - we are Committed, Collaborative and Curiouswe are Biofourmis

Director, Systems Engineering

Biofourmis' technology is applicable to a multitude of different therapeutic areas. We are building out dramatically expanded solutions to address heart failure, oncology, and infectious diseases. The Director of Systems Engineering will play a hands on, critical role leading the design, development, testing, and documentation of our innovative solutions. This individual will lead systems engineering-related activities on cross functional product development programs, demonstrating technical and regulatory expertise as well as outstanding written and verbal communications skills.

Responsibilities

  • Support systems engineering efforts for complex, data-science driven, turnkey medical solutions that span hardware devices, mobile phone apps, and cloud backend; responsibilities for supporting and reporting on all phases of the product development and operations lifecycle including hardware assembly and integration, software builds, releases and updates, configuration control, requirements, design, and test execution.
  • Collaborate with a diverse technical team to lead the creation, update, and maintainance of documentation that is or will become part of the product design history file (DHF) for medical therapeutics solutions.
  • Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed using tools such as Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities when applicable.
  • Facilitate transparent communication between teams and stakeholders, providing regular project updates and metrics addressing any technical or scheduling challenges.
  • Work with subsystem teams and domain subject matter experts in the identification, logging, assessment, and resolution of integration and test issues.
  • Provide technical guidance for product design, development, integration, testing, and reliability improvements.
  • Provide input for submissions to regulatory bodies and governmental agencies.
  • Works with the RA/QA team to ensure product and procedural compliance to regulatory standards.
  • Respond rapidly and flexibly to emerging issues in production, quality, and engineering.
  • Manage a comprehensive solution for capturing requirements, traceability, verification and validation testing suite
  • Identify, champion and drive formal and informal process improvement efforts.
  • Own and lead execution and closure of CAPAs and NCRs
  • Works closely with the VP of Systems Engineering to identify and drive toward team-wide metrics
  • Cultivate a culture of continuous improvement by staying informed about industry trends, technological advancements, and emerging tools in medical device systems engineering, human factors, design controls, reliability testing, and software development.
  • Build and mentor a team of systems engineers to ensure that engineering and quality processes are implemented effectively and consistently across all products.
  • Actively participate in attracting, selecting, retention, and developing the team.

Requirements

  • Bachelor's degree in computer science or related engineering discipline with 10+ years of experience developing highly complex systems
  • 5+ years experience managing technical teams in the development of medical device software.
  • Demonstrated track record in driving results, managing complex projects, nurturing team culture, and adapting to shifting priorities within a dynamic fast paced environment.
  • Successful history of launching and maintaining products within the medical device industry
  • Demonstrated expertise of SDLC, Computer System Validation/Assurance, Design Controls, systems engineering principles, requirements management and medical device QMS regulations including ISO 13485, ISO 14971and 21CFR Design Controls and 21 CFR Production and Process Controls
  • Demonstrated expertise in design, development and testing of software based medical devices.
  • Working knowledge of hardware, firmware and software evaluation to standards IEC 62304, , 21CFR Part 11 and ICH E6 Good Clinical Practice.
  • Experience working with requirement management, collaboration and issue tracking tools such as Jama, Jira, Confluence at the customization level.
  • Significant experience working with agile software development methods such as Scrum and Kanban and exposure to working within CI/CD pipelines.
  • Experience leading and growing a system engineering team including recruiting, hiring, mentoring, professional development, and performance reviews.
  • Experience with cyber security and privacy policies and design requirements.
  • Experience with performance and reliability test strategies and tools.