Director, Product Engineering

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Our flagship product, SIR‑Spheres® Y‑90 resin microspheres, is a targeted radiation therapy for liver cancer.

To date, we have delivered over 150K doses across 50+ countries, significantly impacting patients’ lives worldwide. We create a great workplace with a range of benefits, programs, and services that support employees to contribute to our success and advance their careers.

We are seeking an experienced leader to oversee new product development and design for medical device portfolio.

• Work with internal and external stakeholders to define new product development needs, conceptualize solutions, and design and develop new technologies and products that fulfill market needs.
• Support the ongoing maintenance of Sirtex’s product portfolio from a product design perspective.
• Manage the Design and Sustaining teams, allocating resources to support planned projects and driving timelines.
• Identify, in conjunction with medical, scientific, regulatory, manufacturing, sales and marketing leaders, promising areas of research, technology, and/or product design that address unmet needs, have large potential markets and improve serviceability, manufacturability, reliability, and usability.
• Lead design change or line extension projects for established products to add value, stay current with regulatory requirements, and proactively pre‑empt obsolescence.
• Review and analyze design project proposals to determine feasibility from both engineering and financial perspectives.
• Generate required documentation including timelines, budgets, specifications, testing protocols, design verification protocols and risk analysis.
• Provide technical expertise to support new product development along with operational needs.
• Assist in coordinating the design control system and ensure complete compliance with all requirements.
• Prepare documentation for regulatory submissions and internal quality system.
• Collaborate on pre‑clinical, human factors, and human studies.
• Develop ideas into inventions, prepare patent disclosures and support IP portfolio strategy.
• Develop and manage product and department budgets.

• Bachelor of Science Degree in Engineering required;
  Master’s degree preferred (Mechanical, Electrical, Chemical, or Biomedical Engineering or related field).
• 15+ years of technical leadership experience with Class II – Class III medical devices.
• Sound understanding and relevant experience in supporting clinical studies in the US and Europe.
• Track record of successfully leading medical device development projects and teams in accordance with applicable regulatory guidelines.
• Willingness and ability to institute change and possess inter‑/intra‑organizational influence skills.

The target base salary range for this position will be $165,000 to $207,000 annually. Individual compensation will be based on non‑discriminatory factors, including geographic location, skills, experience, education, and other factors that relate to the position requirements. Actual compensation may vary depending on confirmed job‑related skills and experience.

In addition to the expected base compensation, this role is eligible to participate in Sirtex’s incentive programs (target bonus of 20%) and benefit plans, which include paid sick and vacation time, health insurance, and a generous 401(k) matching program.

All personal information will be kept confidential in accordance with EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe, creating real difference to the quality of people’s lives. We support well‑being, financial health, and work‑life balance for employees to achieve personal success.

• Diverse and flexible work arrangements to achieve the…