Staff Engineer, Biomedical Engineer

SCOPE

This role will involve a range of responsibilities including but not limited to product design, prototyping and bench-testing, verification and validation test design and execution, data analysis, and root cause investigation.

NOTE:

Candidates must be local the Boston, MA area and be able to adhere to our hybrid policy, which is currently 3 days/week in office and 2 days/week remote.

• 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 targeted 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/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

• Minimum Bachelors in Mechanical or Biomedical Engineering (or related engineering or science fields) and 6+ years industry experience. Strong educational preference for Masters 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

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.

• 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…