Director, Product Engineering

Sirtex • Woburn, MA

4h • $165,000 - $207,000 • Hybrid

About The Position

NOTE: This position requires the the chosen candidate to be able to report to the Woburn, MA office weekly. Candidates need to be located in MA and able to be onsite, or must we willing to relocate to accommodate this requirement. Our current hybrid arrangement is 3x/week in office and 2x/week remote.
PRIMARY RESPONSIBILITIES:
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.
Identifies, 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.
Reviews and analyzes 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
Collaboration 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.

Requirements

• Bachelor of Science Degree in Engineering required, Master’s degree is preferred (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.

Responsibilities

• 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.
• Identifies, 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.
• Reviews and analyzes 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
• Collaboration 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.

Benefits

• Diverse and flexible work arrangements to achieve the 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.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

What This Job Offers

• Job Type: Full-time
• Career Level: Director