Director of Research and Development
Location: Woburn MA
Advertising Date: Fri 12 November 2021
Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We are a fast growing, dynamic organization.
The Director, R&D has responsibility for the vision, leadership and controls for the engineering and R&D function at Sirtex. The Director needs to have a breadth and depth of technical, product and business background, as well as an ability to partner across functional, business and geographic boundaries. This role also requires a clear understanding and working knowledge of innovation, medical device development, sustaining engineering, continuous improvement, program management practices, manufacturing/test processes and technologies, and change processes. This is an on-site position based in the Woburn MA office and the employee will be required to work in the office on a regular basis
- Primary responsibilities include the identification, development, and implementation of strategic initiatives for new technologies
- 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.
- Supports design projects for established products targeted to add value, stay current with regulatory requirements, and proactively pre-empt obsolescence.
- Reviews and analyzes proposals submitted to determine if benefits derived and possible applications justify expenses
- Develop product roadmaps for future applications and incorporation of new technologies into products
- Manage diverse product development and launch cycles ranging from integration of new products to product upgrades that meet global customer needs and ultimately increase the number of patients served.
- Assist in driving the platform technology direction for next gen devices and evaluating strategic partnerships and business development projects,
- Coordinate sustaining engineering functions and resources to implement tactical plans that are directly linked to business and operational objectives
- Contribute significantly to the overall pipeline, evaluate novel technologies for addition to the company portfolio
- Generate required documentation including timelines, budgets, specifications, testing protocols, design verification protocols and risk analysis
- 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
- Develop ideas into inventions and prepare patent disclosures and support IP portfolio strategy
- Represent the overall research and development perspective where needed in investor presentations, Board meetings and with business and financial partners and in the company's dealings with regulatory authorities.
- Determine technical and cost feasibility of projects; prepare proposals for new business
- Complete other duties as assigned by manager.
Educational Prerequisites and Skill Requirements
- Bachelor of Science Degree in Engineering required, Master’s degree is preferred (Mechanical Engineering, Plastics Engineering, Chemical Engineering, BioEngineering, Material Science, Polymer Science 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
- Successfully led development of Class III Medical Devices
- Experience with FDA GMP, GLP and design controls
- Experience developing products according to ISO 13485: 2016
- Willingness and ability to institute change and inter/intra organizational influence skills.
- Highly organized, exhibiting meticulous attention to detail, excellent record keeping
- Excellent verbal, written, and analytical skills and ability to interact effectively with Sirtex staff and regulators
Training and Miscellaneous Requirements
- Undergo all formal training, as may be directed from time-to-time
- Observe and comply with all Sirtex corporate policies
- Work within, and ensure adherence to quality system procedures, work instructions and other quality system
- Ability to travel domestically and internationally 25%
Conditions of Employment
- Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021 requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
- Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
What To Expect at Sirtex
If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:
- Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
- A working culture of respect, diversity, and performance to help facilitate an inclusive culture
- Attractive compensation and benefit packages which are practical, robust, fair and equitable
- A place to grow through career development and training opportunities
- Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world
- Travel 40-60% which can include weekends/holidays as needed to achieve goals
- Physical requirements include sitting, walking, standing for prolonged amount of time, possible exposure to radiation.
- Current valid driver’s license
HOW TO APPLY:
To apply, please click the apply button or email your cover letter and resume to Human Resources at firstname.lastname@example.org
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets