Staff Engineer, Systems Integration

Thornton Tomasetti; California; In loco; USD 99.000 - 199.000; Tempo pieno

Descrizione del lavoro

Abbott Laboratories is seeking a Staff Engineer, Systems Integration to guide the system integration across cross-functional teams for IVD medical devices from concept through manufacturing.

The ideal candidate possesses 10+ years in system integration, strong DOE and V&V execution skills, and experience with regulatory compliance and design history files.

Competenze

• Bachelor's degree required; advanced degree preferred.
• 10+ years of relevant IVD system integration experience.
• Authorization to work in the United States without sponsorship.

Mansioni

• Lead system integration activities for cross-functional product development.
• Develop test methods and lead V&V at the system level.
• Ensure traceability of requirements to design outputs and DHF documentation.
• Collaborate with hardware, software, and reagent teams across stages from concept to manufacturing.
• Participate in risk management, HA/FMEA, and regulatory compliance activities.

Conoscenze

System integration

V&V

DOE

Technical writing

Cross-functional collaboration

Regulatory compliance

Formazione

Bachelor's degree in Biology/Systems Engineering/Biomedical Eng

Advanced degree (Masters/PhD) in related field

Strumenti

Requirements management tools

DOE tools

Descrizione del lavoro

Staff Engineer, Systems Integration page is loaded## Staff Engineer, Systems Integrationlocations: United States - California - La Jollatime type: Tempo Integralposted on: Publicado hojejob requisition id: 31159000Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Descritivo de CargoThe Staff Engineer, Systems Engineering is a key problem solver and technical leader to plan and lead the system integration aspects of cross-functional product development projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills to contribute to multiple technologies and product lines across the company. This position will leverage understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence product concept generation, design reviews, test method development, performance testing, and assessment of system interactions.Essential Duties**Include but are not limited to the following:*** Assess design feasibility and test product functionality and/or confirm product capabilities.* Responsible for test method development and lead V&V activities at the system level.* Responsible for traceability of requirements to product design outputs.* Participate in new product design and design improvements to existing products.* Participate in the definition and creation of system architectures and documentation trees.* Lead system integration activities during product design and V&V phases.* Utilize Design of Experiment (DOE) as appropriate.* Drives development and testing to assess performance against design specifications.* Participate in Human Factors Engineering/Usability Engineering tasks and activities.* Strong analytical and problem-solving skills.* Establish interfaces across other organizational groups.* Work independently to apply technical expertise to lead efforts in system design, implementation, integration, and verification and validation (V&V) of medical devices and products.* Participate in requirements management activities involving creation, decomposition, and traceability of requirements.* Prepare and deliver presentations of project results to others; present data to larger and more diverse audiences.* Participate in the evaluation and assessment of competitive products, processes, and/or new trends.* Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight and guidance on evolution of the design.* Collaborate with hardware, software, and reagent team members to develop and implement product designs.* Ensure the necessary documentation for V&V activities are included in the project Design History File (DHF).* Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions.* Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.* Participate in product risk management activities involving system Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA).* Participate in project planning, process updates, design reviews, and contributes to experimental design.* Utilize integration, analytical, and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system issues.* Apply working knowledge of DOE, analysis and interpretation of test results, failure investigation, and root cause failure analysis.* Uphold company mission and values through accountability, innovation, integrity, quality,* Support and comply with the company's Quality Management System policies and procedures.* Regular and reliable attendance.* Ability to work nights and/or weekends.* Ability to lift up to 25 pounds for approximately 5% of a typical working day.* Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.* Ability to comply with any applicable personal protective equipment requirements.* Ability to perform repetitious actions using lab tools and equipment.* Ability and means to travel between Redwood City locations.* Ability to travel 15% of working time away from work location, may include* overnight/weekend travel.**Minimum Qualifications*** Bachelor's degree in Biology, Biochemistry, Systems Engineering, Biomedical Engineering, Physics, or related field.* **Authorization to work in the United States without sponsorship.*** 10+ years of relevant experience, including previous hands-on involvement as an engineer, scientist, or product developer working through a formal phase gate or new product development process in the IVD medical device industry (e.g., System Integration Engineer, System Development Engineer, or related occupation).* Solid technical writing skills to produce reports and documents; writes independently; evaluates the writing of others.* Demonstrated ability to perform the Essential Duties of the position with or without accommodation.**Preferred Qualifications*** Experience with instrument automation or scientific instrumentation.* Six Sigma certification.* Design for Six Sigma (DFSS) experience.* Proficiency with formal requirements management tools.* Advanced degree (Masters / PhD) in Biology, Biochemistry, Systems Engineering,* Biomedical Engineering, Physics, or related field.* Experience with next generation sequencing, immuno-histochemistry, in-situ hybridization, PCR, methylation.* Experience with system analysis, model-based system engineering, and system* architecture**The base pay for this position is**$99,300.00 - $198,700.00In specific locations, the pay range may vary from the range posted.Família de CargoProduct DevelopmentDivisãoONCO Cancer DiagnosticsLocalidadeUnited States > La Jolla: Torrey Pines Science ParkLocalidades AdicionaisTurno de TrabalhoStandardViagemNoVigilância médicaNoAtividades de trabalho significativasContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO\\_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf