Apply on Employer Site

Abbott · 1 month ago

Systems Engineering Manager, Sustaining

United States - California - Alameda

Full-time

Onsite

Senior Level, Lead/Staff

$147K/yr - $293K/yr

8+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Systems Engineering Manager, Sustaining will work within R&D to utilize telemetry data for product performance analysis and maintain risk files for on-market products.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Work with product owner, as a customer represent hardware and firmware teams, for ongoing development of telemetry system

Guide analysis of telemetry data to gain insights into product behavior in the field

Effectively communicate with development teams, driving product improvement

Maintaining living risk assessments, design documentation, and other design history file documents to address newly identified risks, emerging standards, and product improvements

Review risk evaluations

Review of medical device reports in MAUDE databases for previously unrecognized risks/hazards. Work with organization to mitigate these risks

Work with development teams on feedback learning from sustaining activities

Maintain best practices and drive continuous improvement activities

Cultivate solid working relationships cross functional teams

Investigate complaints from on market products

Write and submit engineering change orders in Agile (a product lifecycle management tool)

Provide guidance and/or act as independent review in programs not directly involved

Communicate effectively and participate on cross functional development teams with good negotiating skills to direct multi-disciplinary teams toward solutions

Comply with all applicable Corporate and Divisional Policies and perform other duties as assigned by the Management Team

Qualification

Medical device risk managementTelemetry system developmentMedical device systems developmentModel based systems engineeringAgile development methodologiesContinuous integration & developmentMedical device software developmentAnalytical skillsGuidance to junior team membersProblem-solving skills

Required

Bachelor's (BS) degree and minimum 10 years of relevant experience in engineering (or MS degree with minimum 8 years experience, or PhD with minimum 6 years of experience)

Advanced level of experience with application of medical device risk management per ISO 14971

Experience analyzing system and hardware event logs to diagnose performance, functionality, and operational issues

Experience with mobile software or application development including telemetry

Experience with medical device systems development per FDA and EU design control regulations

Experience with model based systems engineering (MBSE), UML, and SysML

Demonstrated success in technical proficiency, creativity, and independent thought

Strong analytical & problem-solving skills

Ability to provide guidance to junior team members

Preferred

Experience creating risk assessments to drive testing to standards such as 60601-1, 60601-1-2

Understanding of agile development and test methodologies

Understanding of software development process, bug and feature request tracking

Knowledge of continuous integration & continuous development (CI/CD)

Advanced level of knowledge with continuous integration & continuous development (CI/CD)

Advanced level of experience with medical device software development per IEC 62304

Experience with IBM Engineering Requirements Management DOORS, Cameo MagicDraw, and Jira

Benefits

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

Training and career development, with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k) retirement savings with a generous company match

The stability of a company with a record of strong financial performance and history of being actively involved in local communities