Staff Engineer, Regulatory Compliance Specialist

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 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.