Senior Systems Engineer - R&D | Medical Devices | Mount Waverley | PRD/ALM & New Product Release Experience required
Beckman Coulter
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System which makes everything possible.
The Senior Systems Engineer is responsible for providing systems engineering expertise to a cross-functional hardware engineering team that are working on a multitude of development projects.
Location: This position reports to the Hardware Engineering Manager and is part of the R&D department located in Mount Waverley, Melbourne and will be an on-site full-time role.
In this role, you will have the opportunity to:
- Lead the development and implementation of hardware system strategies throughout an R&D cross-functional team, providing thorough technical guidance aligned with product requirements, project objectives, and functional workflows .
- Lead system verification and validation strategies and activities for Train releases, including developing test protocols and executing integration, verification, and validation testing.
- Deliver robust and high-quality engineering solutions that are compliant with all applicable business and regulatory requirements.
- Perform trade-off analysis to assess various design options, considering factors such as performance, cost, risk, and user experience.
- Drive engineering changes through to full release across complex systems, following Leica Biosystems' QMS, while leading on Systems related tasks.
The essential requirements of the job include:
- Minimum 3 years of experience in the Research & Development department within highly regulated industries (medical devices, defense, aerospace, pharmaceutical), with experience releasing new products to market,
- Degree qualified Engineer with minimum 8 years’ relevant experience in developing and delivering complex electro-mechanical devices using a variety of manufacturing methods and working with suppliers.
- Experience with PRD (product requirements documentation systems), and ALM (Application Lifecycle Management) .
- Self-driven and proactive, with the ability to communicate effectively across diverse stakeholder groups, including electronic engineers, production teams, and operators.
- Excellent technical communication skills, able to convey complex technical concepts clearly to both technical and non-technical audiences.
- Strategic mindset, with a strong interest in planning, forecasting, and aligning work with broader business objectives.
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
- Ability to travel - less than 10% of role.
It would be a plus if you also possess previous experience in:
- Designing, conducting and documenting verification and validation of designs.
- Project management experience.
- ISO 13485 and FDE QSR 820
- IEC 61010
- Up to date Victorian state engineering registration in Mechanical and/or Electrical Engineering or eligibility to get registered (with proof of streamlined eligibility, such as Washington Accor listed degree). Note: It is the responsibility of the Engineer to keep their registration status current to provide professional engineering services in Victoria, with the level of responsibilities set out in this position description.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.