Staff 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.
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
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, which include paid sick and vacation time, health insurance and a generous 401k matching program.

Employment type
Full-time

Work arrangement
Hybrid