Senior Product Development Engineer

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated toimproving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering withphysicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achievingthis ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagshipproduct, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we havedelivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueledby our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture,nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services tosupport our employees, ensuring they have opportunities to contribute to our success and advance their careers. Joinour inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance yourcareer, all while delivering innovative healthcare solutions to patients.

A Product Development Engineer (Level Senior) is responsible in developing new technologies, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team leading technically and cross functionally, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.

• Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Select techniques to solve complex problems and make sound design recommendations.
• Designs and prepare complex reports to communicate results to technical community.
• Designs and coordinates complex engineering tests and experiments.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Interfaces with Physicians/Lab personnel to obtain feedback on concepts and performance of new devices.
• Works cooperatively with operation, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
• May train and/or provide work directions to interns, technicians and entry-level engineers.
• Fully participates in and successfully contributes to project teams including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
• Perform product verification and validation testing, to ensure high-quality results and compliance with industry standards.
• Develop and maintain detailed product technical specifications, engineering drawings, and bill of materials (BOM).
• Designs, procures, and fabricates tooling and fixtures.
• Performs troubleshooting on new products/process problems related to design, material, or process.
• Collaborate with suppliers and vendors to source materials and components for product development.
• Evaluate and incorporate feedback from customers, end-users, key opinion leaders (KOL) and other stakeholders to improve product designs.
• Lead inter-disciplinary technical reviews intended to provide a systematic assessment of design results, device design and Design for Manufacturability (DFM). Create, draft and release technical reports required for product/process development programs.
• Lead the design knowledge transfer of new manufacturing processes and provide training to product builders and technicians.
• Establish and maintain appropriate design controls documentation, design trace matrices, design history files, technical files and device master records.
• Develop and execute required validations per QMS requirements to include Equipment, Process & Product validations.

• Bachelor's of Science degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Plastics Engineering or a related field. Master of Sciencedegree is preferred.
• 5+ years of in-depth conceptual, practical and technical and/or functional knowledge of principles of product development required.
• Medical Device experience is required
• Solves a significant range of problems of varying scope and complexity.Exchangecomplex information with others, potentially guiding and influence others.
• May lead complexprojects with high level of risks and resource requirements
• Applies understanding of key business drivers in the context of the organization's industry and how closely related teams integrate with others to accomplish their objectives and drive efficiencies.
• Supports team members by setting an example, coaching and providing feedback and guidance.
• Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems.
• Impacts quality and effectiveness of customer, operational, project/program or service activities within own team and other related teams.
• Regularly participates in discussions and presentations in cross-functional meetings, logically presenting information to convey key messages with SLT and middle management teams.

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people's lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.