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Danaher Corporation Lead Systems Engineer in Marlborough, Massachusetts

Help us improve access to life-changing therapies that can transform human healthWe are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.What you'll doThe Lead Systems Engineer will focus on complex product design and system integration, intellectual property development, problem solving, risk reduction, system verification and documentation for development of bioprocess equipment and sterile consumables for the pharmaceutical industry. He/she is responsible for supporting and/or leading the integration of mechanical, electrical, consumable (e.g. plastic) and automation subsystems for successful development.

  • The Lead Engineer will contribute and/or be responsible for coherence and compliance of the system development with systems engineering principles and processes.

  • Accountable for the system integration of subsystems for new bioprocessing equipment and consumables such as in the Xcellerex, WAVE, and ReadyToProcess product lines.

  • Lead through engagement, collaboration and indirect influence of cross-functional resources to obtain consensus, while connecting with people empathetically, energizing and motivating your teammates, and inspiring them to work toward the project goals.

  • Support creation of platform design aligned to long-term technology roadmap. Help develop architecture viewpoint, relate the architecture to design and remove ambiguity, and manage selected architecture while communicating clear outlines of system architecture and function.

  • Support technical scope definition, VOC and user experience (UX) activity, intellectual property development, risk retirement & feasibility prove-out.

  • Lead requirement management across cross-functional team from product inception through commercial launch of system or sub-system.

  • Perform functional analysis, work cross-functionally, and apply creativity to resolve problems when presented with conflicting requirements, business demands and technical risks/issues.

  • Address implementation complexity, risks, manufacturability, serviceability and quality.

  • Foster inclusive design review process to reduce risk, ability to do trade-off analysis with program metrics (e.g. cost, schedule), and ensure continued alignment with business.

  • Architect system verification & validation strategy, manage and lead defect resolution, trace matrix, and support design transfer.

  • Maintain compliance with design controls, program documentation including internal phase review discipline, site quality and regulatory system.

  • Interface broadly across project and global engineering teams; cross functionally with Quality/Regulatory, Service, Manufacturing, Sourcing, Project Management, and Marketing; and with various external development teams.

  • Maintain open communications with company leadership and ongoing engagement of line management in project activities.

  • Establish and maintain good understanding of clients, industry, and commercial markets.

  • Contribute to multiple projects/demands simultaneously.

Who you are

  • BS Degree in Mechanical, Electrical, Biomedical Engineering or related degree. A Master’s Degree in Engineering (Electrical, mechanical, plastics or similar field) preferred.

  • Minimum 5 years’ relevant post-academic experience.

  • Experience with ISO (9001/13485), and regulatory standards and requirements.

  • Knowledge in statistical analysis, DOE, impact assessment, root cause analysis, and risk management/FMEA.

  • Experience with design for usability and electrical safety compliance.

  • History of leading and conducting Design Reviews, and exposure to system modeling language.

  • Experience with design verification and validations.

  • Effective communication skills and ability to work cooperatively within a global, multidisciplinary team, including written and oral communication.

  • Broad knowledge across mechanical, electrical and software engineering, as part of combined HW/SW systems.

  • Deep knowledge in at least one discipline, including electrical, mechanical or software/automation engineering. Diverse technical understanding and ability to apply skills/knowledge to new technology.

  • Demonstrated collaboration, negotiation & conflict resolution skills.

  • Minimum of 2 years direct experience in System Engineering including designing and launching products.

  • Proficient with 3D CAD modeling software.

  • Knowledge of FEA and CFD analysis, their benefits and where to apply them.

  • Ability to manage documentation including requirements, block diagrams, specifications, cost analysis, engineering analysis, drawings, fluidic schematics, BOMs, test cases/reports, presentations, and traceability matrices.

Who we areWhatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.