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Cochlear

Manager, Systems Engineering, and Software Business Analysis

Posted 2 Days Ago
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In-Office
Sydney, New South Wales, AUS
Senior level
In-Office
Sydney, New South Wales, AUS
Senior level
Lead systems engineering and software business analysis for medical devices. Oversee multidisciplinary teams ensuring system compliance, effectiveness, and risk management across complex software ecosystems.
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Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.

  • Lead systems engineering, business analysis and system V&V for regulated medical device software

  • Drive system‑level behaviour, requirements and verification across complex hardware‑software ecosystems

  • Build high‑performing multidisciplinary teams delivering life‑changing clinical solutions

The Opportunity

The Manager, Software Systems Engineering & Business Analysis is a senior leadership role responsible for defining and governing system behaviour across Cochlear’s complex medical device software ecosystem. You will lead multidisciplinary teams spanning Systems Engineering, Software Business Analysis and System Verification & Validation, ensuring safe, compliant and clinically effective system delivery.

Operating at the intersection of clinical intent, system architecture and regulated delivery, this role provides both people leadership and deep technical authority. You will influence system-level decisions across customer software, workflow engines, algorithmic modules, firmware integration and device communication layers, while building discipline maturity and engineering excellence across the organisation.

Responsibilities include:

  • Lead and develop multidisciplinary teams across Systems Engineering, Software Business Analysis and System V&V, building capability, engagement and succession

  • Define and govern system‑level behaviour, ensuring requirements are clear, traceable, verifiable and aligned to clinical intent

  • Establish and maintain end‑to‑end traceability across user needs, system requirements, interfaces and verification evidence

  • Lead system‑level technical decision‑making, risk management and issue resolution in complex, safety‑critical environments

  • Ensure compliance with medical device regulatory and quality standards including ISO 13485, ISO 14971, IEC 62304, IEC 60601 and FDA requirements

  • Sponsor and chair system‑level design reviews, ensuring architectural alignment, integration readiness and verification depth

  • Act as a primary interface between architecture functions and delivery teams to ensure effective system implementation

  • Champion systems thinking, discipline excellence and continuous improvement through guild leadership, process ownership and tool evolution

About You.

As we grow our operations, we are looking for people who share our passion delivering safe, effective, and high-quality hearing solutions. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:

  • Extensive experience leading multidisciplinary R&D teams in regulated medical device environments

  • Deep expertise in software‑centric systems engineering, requirements engineering and system‑level verification

  • Strong working knowledge of medical device regulatory and quality frameworks (ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA)

  • Proven ability to define, govern and verify complex system behaviour across software, firmware and hardware interfaces

  • Excellent decision‑making and risk management capability in ambiguous, safety‑critical contexts

  • Highly effective communication and stakeholder influence skills across technical, clinical and executive audiences

  • What Would Make You Stand Out

  • Experience leading system behaviour definition for workflow‑driven software, parameter‑driven algorithms or real‑time communication systems, along with a track record of building discipline maturity through standards, tooling and engineering process improvement.

Why this role is for you?

This role offers the opportunity to operate as both a people leader and technical authority in one of Cochlear’s most complex engineering domains. You’ll shape system behaviour that enables safe, reliable clinical outcomes, influence future platform evolution, and build high‑performing teams whose work directly changes lives.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

#CochlearCareers

How we recognise your contribution

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about Life at Cochlear, visit www.cochlearcareers.com

Top Skills

Fda
Iec 60601
Iec 62304
Iso 13485
Iso 14971

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