Sirtex is looking for a Director, Product Engineering to lead product engineering efforts for its portfolio of medical devices. In this role, you will be responsible for new product development and sustaining engineering for our existing products, managing teams, driving project timelines, and ensuring regulatory compliance. We are dedicated to improving patient outcomes through minimally invasive cancer and embolization therapies.
What You'll Do
- Work with internal and external stakeholders to define new product development needs, conceptualize solutions, and design and develop new technologies and products.
- Support the ongoing maintenance of Sirtex’s product portfolio from a product design perspective.
- Manage the Design and Sustaining teams, allocating resources to support planned projects and driving timelines.
- Identify promising areas of research, technology, and/or product design that address unmet needs and improve serviceability, manufacturability, reliability, and/or usability.
- Lead design change or line extension projects for established products to add value, stay current with regulatory requirements, and pre-empt obsolescence.
- Review and analyze design project proposals to determine feasibility from both engineering and financial perspectives.
- Generate required documentation including timelines, budgets, specifications, testing protocols, design verification protocols and risk analysis.
- Provide technical expertise to support new product development along with operational needs.
- Assist in coordinating the design control system and assure complete compliance with all requirements.
- Prepare documentation for regulatory submissions and internal quality system.
- Collaborate on pre-clinical, human factors, and human studies.
- Develop ideas into inventions and prepare patent disclosures and support IP portfolio strategy.
- Develop and manage product and department budgets.
What We're Looking For
- Bachelor of Science Degree in Engineering (Mechanical, Electrical, Chemical, or Biomedical Engineering or related field).
- 15+ years related technical leadership experience with Class II - Class III medical devices.
- Sound understanding and relevant experience in supporting clinical studies in the US and Europe.
- Track record of successfully leading Medical Device development projects and teams in accordance with applicable regulatory guidelines.
- Willingness and ability to institute change and inter/intra organizational influence skills.
Nice to Have
- Master’s degree in Engineering.
Team & Environment
You will manage the Design and Sustaining teams. Our culture is one of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance. We are committed to our values, employee safety, and excellence.
Benefits & Compensation
- Compensation: $165,000 to $207,000 annually.
- Incentive programs (target bonus of 20%).
- Generous 401k matching program.
- Health insurance.
- Paid sick and vacation time.
- Diverse and flexible work arrangements.
- Support for ongoing professional growth through career development, on the job experiences and training opportunities.
Work Mode
This role offers a hybrid work arrangement for candidates located near our office in Woburn, MA.
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.
