Associate Academic Research Scientist performing complex research duties in Radiation Oncology at Emory University. Leading scientific projects and ensuring research quality and compliance standards.
About the role
- Associate Principal Scientist leading design controls for medical devices and combination products. Collaborating with cross-functional teams for product development from concept to commercialization.
Responsibilities
- Lead/contribute to device development, design controls for the assigned projects.
- Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.
- Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.
- Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
- Lead the preparation of materials for program presentations for management review and regulatory submission.
- Contribute to the development, implementation, and continuous improvement of design controls processes, procedures, and tools.
- Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.
- Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others.
Requirements
- B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 10 years of related experience
- Has broad knowledge of medical device development, design controls and risk management
- Led and managed development of DHF (design history file) deliverables for medical devices
- Recognized as a subject matter expert in at least one medical device development or design controls area
- Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.
- Proven track record of applying analytical skills in product design, development, and evaluation
- Self-motivated and work independently
- Proven ability to work with team members of diverse skill sets and backgrounds
- Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership
- Excellent communication, presentation, negotiation, project management, and organizational skills
- Willing to travel
- Able to quickly pick up advanced domain knowledge
- Able to multi-task continuously
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Supporting in commercial contracts and liability queries in the automotive sector. Engaging in extrajudicial and judicial supply chain disputes while gaining insights into complex contractual cases.
Postdoctoral position working in a collaborative project to develop a new treatment for colorectal cancer using organoid models. Aimed at bridging academic and industry - related research in health.
Principal Scientist leading outcomes research in Hematology at a global health care firm. Focus on generating real - world evidence for innovative products and healthcare outcomes.
UG
Postdoctoral Research Fellow studying molecular/epigenetic epidemiology at the University of Edinburgh. Engaging in research on biomarkers linked to organ ageing and disease outcomes, contributing to projects and collaborations.
Wissenschaftlicher Mitarbeiter in Mikrobiologie bei MVZ diagnosticum GmbH. Verantwortlich für Projektleitung und fachliche Anleitung im medizinischen Labor.
Associate Director for Data Strategy contributing to real - world evidence with advanced analytics and partnerships. Driving innovative projects in healthcare decision - making and data science in a collaborative environment.
Principal Scientist leading CDx/IVD development projects in Translational Oncology within a leading health care company. Collaborating with teams on diagnostics and biomarker strategies.
Research Assistant in Electrolysis at Fraunhofer Institute specializing in hydrogen technology development. Engaging in cutting - edge research and innovative projects in electrochemical processes.
Principal Scientist responsible for drug discovery activities within Small Molecule Research at Novo Nordisk. Leading assay development, managing CROs, and collaborating across teams globally.