Staff Engineer, Systems Integration
Job Location:
La Jolla, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
The Staff Engineer Systems Engineering is a key problem solver and technical leader to plan and lead thesystem 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 contributeto multiple technologies and product lines across the company. This position will leverage understanding of advanced engineering principles advanced engineering methods data and judgment to influenceproduct concept generation design reviews test method development performance testing andassessment 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 designimplementation integration and verification and validation (V&V) of medical devices andproducts.
- Participate in requirements management activities involving creation decomposition andtraceability of requirements.
- Prepare and deliver presentations of project results to others; present data to larger andmore diverse audiences.
- Participate in the evaluation and assessment of competitive products processes and/ornew trends.
- Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight andguidance on evolution of the design.
- Collaborate with hardware software and reagent team members to develop and implementproduct designs.
- Ensure the necessary documentation for V&V activities are included in the project DesignHistory File (DHF).
- Assist in the development of manufacturing processes and troubleshooting issues todetermine root cause and possible engineering solutions.
- Collaborate with cross-functional teams to ensure all development activities are conductedin adherence to applicable national/international regulations guidelines company policiesSOPs and industry standards.
- Participate in product risk management activities involving system Hazard Analysis (HA) andFailure Modes and Effects Analysis (FMEA).
- Participate in project planning process updates design reviews and contributes toexperimental design.
- Utilize integration analytical and troubleshooting skills to understand system interfaces andbe able to quickly analyze troubleshoot and resolve system issues.
- Apply working knowledge of DOE analysis and interpretation of test results failureinvestigation and root cause failure analysis.
- Uphold company mission and values through accountability innovation integrity quality
- Support and comply with the companys Quality Management System policies andprocedures.
- 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 workstanding 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
- Bachelors degree in Biology Biochemistry Systems Engineering Biomedical EngineeringPhysics or related field.
- Authorization to work in the United States without sponsorship.
- 10 years of relevant experience including previous hands-on involvement as an engineerscientist or product developer working through a formal phase gate or new productdevelopment process in the IVD medical device industry (e.g. System Integration EngineerSystem 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 withoutaccommodation.
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 hybridizationPCR methylation.
- Experience with system analysis model-based system engineering and system
- architecture
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Staff IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
