Job DescriptionSCOPE: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, which include paid sick and vacation time, health insurance and a generous 401k matching program
Additional InformationAll your information will be kept confidential according to EEO guidelines.
