Staff Engineer

Sirtex Medical Limited; Woburn (MA); Hybrid; USD 130,000 - 157,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Hybrid work policy

Job summary

Sirtex Medical Limited in the Boston area is seeking an experienced Mechanical or Biomedical Engineer to lead design, prototyping and testing of innovative medical devices. You will collaborate across regulatory, manufacturing and clinical teams to ensure compliant, high-quality products.

This role follows a hybrid policy with three days in the office and two remote days. You will plan and execute verification activities, build prototypes, and drive risk analyses while maintaining adherence to

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering and 6+ years industry experience.
• Experience in design of Class II and Class III medical devices or combination products.
• Strong project leadership and cross-functional collaboration.

Responsibilities

• Design and develop new medical devices and products.
• Support research, regulatory, manufacturing, and sales in design.
• Plan and coordinate project tasks and timelines.
• Create test methods, verification protocols, and risk analyses.
• Coordinate with outside vendors and clinicians.
• Ensure compliance with Sirtex regulatory standards.

Skills

Mechanical design

Biomedical engineering

Project leadership

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's in Mechanical or Biomedical Engineering

Master's degree preferred

Job 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 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

The target base salary range for this position will range from $130,000 to $157,000 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 5% for this position) and benefit plans

• paid sick and vacation time
• health insurance
• 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.