Director, Product Engineering; class II or III medical device

Director, Product Engineering (class II or III medical device)

• Full-time
• Compensation: USD 165,011 - USD 206,264 per year
• Location:
  
  Woburn, MA (must be onsite weekly; hybrid 3x/week in office)

• 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 the 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, 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 assuring 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 to support IP portfolio strategy.
• Develop and manage product and department budgets.

• Bachelor of Science Degree in Engineering required (Mechanical, Electrical, Chemical, or Biomedical Engineering or related field). Master’s degree is preferred.
• 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 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.

• Base salary range: $165,000 to $207,000 annually.
• Target bonus of 20% for this position.
• Paid sick and vacation time, health insurance, and a generous 401(k) matching program.
• Flexible work arrangements to achieve balance between work and personal responsibilities.
• Commitment to support ongoing professional growth.
• The company values diversity, inclusion, and employee safety.

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 your information will be kept confidential according to EEO guidelines.