Staff Engineer, Biomedical Engineer

Company Description 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 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.

PRIMARY 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 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

Qualifications

Minimum Bachelors in Mechanical or Biomedical Engineering (or related engineering or science fields) and 10+ 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…