Director, Product Engineering; class II or III medical device

Job Requirements

This position requires the chosen candidate to report to the Woburn, MA office weekly. Candidates must be located in MA and able to be onsite, or they must be willing to relocate to accommodate this requirement. The current hybrid arrangement is 3 days per week in office and 2 days per week remote.

• Work with internal and external stakeholders to define new product development needs, conceptualize solutions, and design and develop new technologies and products that fulfill market needs.
• 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, in conjunction with medical, scientific, regulatory, manufacturing, sales and marketing leaders, promising areas of research, technology, and/or product design that address unmet needs, have large potential markets and improve serviceability, manufacturability, reliability, and/or usability.
• Lead design change or line extension projects for established products targeted to add value and stay current with regulatory requirements and proactively 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.

• Bachelor of Science Degree in Engineering required;
  Master’s degree is preferred (Mechanical, Electrical, Chemical, or Biomedical Engineering or related field).
• 15+ years of related technical leadership experience with Class II – Class III medical devices.
• Sound understanding and relevant experience in supporting clinical studies in the United States 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.

The target base salary range for this position is $165,000 to $207,000 annually. Individual compensation will be based on non‑discriminatory factors, including geographic location, skills, experience, education and other factors relative to the position requirements. Actual compensation may vary depending on confirmed job‑related skills and experience. In addition to the expected base compensation, this role is eligible to participate in Sirtex’s incentive programs with a target bonus of 20% and benefit plans that include paid sick and vacation time, health insurance and a generous 401(k) matching program.

• Diverse and flexible work arrangements to achieve an 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.
• Opportunity to work on challenging projects that support the development of new and better ways to improve clinical outcomes for oncology treatment worldwide.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

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.

All information will be kept confidential in accordance with EEO guidelines.