Systems Engineering Manager, Sustaining at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

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 Qualifications
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

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

Skills

Key technologies and capabilities for this role

Systems EngineeringTelemetryRisk AssessmentHardwareFirmwareData AnalysisDesign DocumentationR&D

Questions & Answers

Common questions about this position

What benefits does Abbott offer employees?

Abbott provides 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.

Is this position remote or does it require working from an office?

The role requires working from either the Alameda, CA or Milpitas, CA facilities.

What is the minimum education required for this role?

A Bachelor’s (BS) degree is required.

What does Abbott say about its company culture and work environment?

Abbott emphasizes doing work that matters, opportunities to grow and learn, caring for yourself and family, being your true self, and living a full life. It is recognized as a great place to work in dozens of countries, one of the most admired companies by Fortune, and a best place for diversity, working mothers, female executives, and scientists.

What experience or skills make a strong candidate for this position?

Strong candidates will have experience utilizing telemetry data for product performance, maintaining living risk files, guiding data analysis, communicating effectively with cross-functional teams, and working on sustaining activities for on-market products.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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