ICON Strategic Solutions
Senior Director, Design Control- Cambridge MA- Hybrid
ICON Strategic Solutions, Cambridge, Massachusetts, us, 02138
Senior Director, Design Control- Cambridge MA- Hybrid
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Senior Director, Design Control- Cambridge MA- Hybrid
Lead and manage the IVD design control team, providing direction, support, and mentorship.Develop and implement strategic plans for IVD design control activities in alignment with company objectives and ensure all IVD design control activities comply with applicable regulations and standards including assay development and validation and kit production.Core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during internal and external audits and inspections by supplying necessary documentation and addressing findings related to design control and regulatory compliance.Ensure the IVD design control processes comply with relevant regulatory requirements, including FDA, ISO 13485, IVDR, CLIA, and other applicable standards.Establish and maintain IVD design control procedures, templates, and tools.Ensure robust ISO14971 risk management processes are integrated into the design and development phases and risk management is performedOversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Plan and conduct design phase review meetingsLead IVD design control activities for new product development projects, ensuring timely and compliant progression through design phases.Coordinate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Manufacturing, to ensure cohesive and compliant product development.Monitor project timelines, budgets, and resource allocation to ensure projects are completed on time and within budget and oversee the project management team for assay development.Drive periodic improvement initiatives to enhance IVD design control processes, efficiency, and product quality.Implement lessons learned from post-market surveillance and product performance to improve IVD design control practices.Develop and deliver training programs on IVD design control requirements for internal teams.Promote a culture of quality and compliance within the organization through regular communication and training.Expected travel needs approximately 25%.
To be successful in this role, you will have:Minimum of 10 years of experience in design control within the medical device or clinical laboratory industryPhD in science related field preferredIn-depth knowledge of FDA regulations, ISO 13485, ISO14971, IVDR, CLIA, and other relevant standardsExperience with Laboratory Developed Tests (LDTs) and understanding of their regulatory requirementsStrong project management skills with experience leading cross-functional teamsProven leadership experience with the ability to manage and mentor a teamStrong interpersonal and communication skills, good laboratory, and organizational skills, including the ability to work independently and efficiently.Ability to multitask, along with an orientation toward teamwork and leadership, and strong creative thinking and problem-solving skills.
Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
design control experience
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Senior Director, Design Control- Cambridge MA- Hybrid
Lead and manage the IVD design control team, providing direction, support, and mentorship.Develop and implement strategic plans for IVD design control activities in alignment with company objectives and ensure all IVD design control activities comply with applicable regulations and standards including assay development and validation and kit production.Core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during internal and external audits and inspections by supplying necessary documentation and addressing findings related to design control and regulatory compliance.Ensure the IVD design control processes comply with relevant regulatory requirements, including FDA, ISO 13485, IVDR, CLIA, and other applicable standards.Establish and maintain IVD design control procedures, templates, and tools.Ensure robust ISO14971 risk management processes are integrated into the design and development phases and risk management is performedOversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Plan and conduct design phase review meetingsLead IVD design control activities for new product development projects, ensuring timely and compliant progression through design phases.Coordinate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Manufacturing, to ensure cohesive and compliant product development.Monitor project timelines, budgets, and resource allocation to ensure projects are completed on time and within budget and oversee the project management team for assay development.Drive periodic improvement initiatives to enhance IVD design control processes, efficiency, and product quality.Implement lessons learned from post-market surveillance and product performance to improve IVD design control practices.Develop and deliver training programs on IVD design control requirements for internal teams.Promote a culture of quality and compliance within the organization through regular communication and training.Expected travel needs approximately 25%.
To be successful in this role, you will have:Minimum of 10 years of experience in design control within the medical device or clinical laboratory industryPhD in science related field preferredIn-depth knowledge of FDA regulations, ISO 13485, ISO14971, IVDR, CLIA, and other relevant standardsExperience with Laboratory Developed Tests (LDTs) and understanding of their regulatory requirementsStrong project management skills with experience leading cross-functional teamsProven leadership experience with the ability to manage and mentor a teamStrong interpersonal and communication skills, good laboratory, and organizational skills, including the ability to work independently and efficiently.Ability to multitask, along with an orientation toward teamwork and leadership, and strong creative thinking and problem-solving skills.
Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
design control experience