Staff Engineer

About the Company

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes through minimally invasive cancer and embolization therapies. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer, with over 150,000 doses delivered across 50+ countries. We partner with physicians to provide innovative products that enhance patient outcomes and simplify treatments, fostering a collaborative, entrepreneurial, and innovative work culture.

About the Role

This role involves a range of responsibilities, including product design, prototyping, bench-testing, verification and validation test design and execution, data analysis, and root cause investigation. Candidates must be local to the Boston, MA area and adhere to our hybrid policy of 3 days/week in office and 2 days/week remote.

Responsibilities

• Utilize multidisciplinary engineering knowledge and experience to design and develop new products
• Support medical, scientific, regulatory, manufacturing, marketing, and sales in product research, technology, and design
• Support design projects for established products to add value, stay current with regulatory requirements, and proactively pre-empt obsolescence
• Plan, schedule, and coordinate project tasks and activities
• Utilize structured problem-solving approaches to resolve design investigations during development or for on-market products
• Conceive and build working prototypes
• Run empirical and experimental analysis utilizing various analytical design tools
• Work with outside consultants, suppliers, and customers (including clinicians)
• Perform tolerance analyses of complex assemblies
• Support bench, animal testing, and clinical evaluations
• Establish product requirements and specifications
• Establish test method and model development
• Generate required documentation including timelines, budgets, specifications, testing protocols, design verification protocols, and risk analysis
• Identify and mitigate project risks
• Assist in coordinating the design control system and assure complete compliance with all requirements
• Prepare documentation for regulatory submissions and internal quality system
• Develop and coordinate efficient manufacturing processes with third parties as needed
• Collaborate on pre-clinical, human factors, and human studies
• Ensure compliance with procedural and documentation requirements of Sirtex Global, FDA, ISO, and other regulatory bodies

Requirements

• Minimum Bachelor’s in Mechanical or Biomedical Engineering (or related engineering or science fields) and 6+ years of industry experience
• Strong educational preference for a Master’s degree in Mechanical or Biomedical Engineering/related degree, or equivalent years of experience
• Experience in the design of Class II and Class III medical devices or combination products required
• Experience working in a broader enterprise/cross-division business units model
• Experience in designing mechanical and electro-mechanical devices
• Project leadership and management skills

Benefits

• Diverse and flexible work arrangements to achieve work-life balance
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance
• Attractive compensation and benefit packages
• Commitment to ongoing professional growth through career development, on-the-job experiences, and training opportunities
• Challenging work supporting the development of new and better ways to improve clinical outcomes for oncology treatment worldwide
• An unwavering commitment to company values, employee safety, and excellence