Staff Engineer

Sirtex•Woburn, MA

6d•$130,000 - $157,000•Hybrid

About The Position

Sirtex Medical is a global leader in healthcare, dedicated to improving patient outcomes through minimally invasive cancer and embolization therapies. We partner with physicians 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, with over 150K doses delivered worldwide. Our success is driven by our dedication to the medical community, professionalism, collaboration, an entrepreneurial spirit, and continuous innovation. At Sirtex, we are committed to creating a great workplace with benefits, programs, and services to support employee growth and success. Join our inclusive community to collaborate, innovate, and advance your career while delivering healthcare solutions.

Requirements

Minimum Bachelors in Mechanical or Biomedical Engineering (or related engineering or science fields)
6+ years industry 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

Nice To Haves

Strong educational preference for Masters degree in Mechanical or Biomedical Engineering/related degree, or equivalent years of experience

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