Director, Product Engineering (class II or III medical device)

Director, Product Engineering (Class II or III Medical Device)

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. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. 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. Our success is fueled by 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 to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

Note: This position requires the chosen candidate to be able to report to the Woburn, MA office weekly. Candidates need to be located in MA and able to be onsite, or must be willing to relocate to accommodate this requirement. Our current hybrid arrangement is 3x/week in office and 2x/week remote.

Primary Responsibilities:

• 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.
• Identifies, 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/or usability.
• Lead design change or line extension projects for established products targeted to add value, stay current with regulatory requirements, and proactively pre-empt obsolescence.
• Reviews and analyzes 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 assure complete compliance with all requirements
• Prepare documentation for regulatory submissions and internal quality system
• Collaboration on pre-clinical, human factors, and human studies
• Develop ideas into inventions and prepare patent disclosures and support IP portfolio strategy
• Develop and manage product and department budgets.

Qualifications

• Bachelor of Science Degree in Engineering required, Master's degree is preferred (Mechanical, Electrical, Chemical, or Biomedical Engineering or related field)
• 15+ years related 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 inter/intra organizational influence skills.

The target base salary range for this position will range from $165,000 to $207,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements. Actual compensation may vary depending on the 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% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.

Additional Information

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.