The Job Responsibilities
Responsible for product and/or system safety risk management activities and deliverables throughout the product life cycle in accordance with internal processes and external standards.
- Implements the risk management process throughout the development cycle, ensuring that risks are identified, control measures are defined, verified and effective, according to ISO 14971 and Draeger process standards.
- Ensures compliance to EU MDR, industry Standards and FDA Regulations and Guidance’s to ensure risk management requirements and principles are implemented in the development of products.
- Creates and maintains product-related files and reports (e.g. Product Risk Management File, Product Risk Management Report, Clinical Risk Management Report, Review of Post Production Information, Essential Requirements Checklist, List of Critical Components) that support compliance efforts and enhance product safety and performance.
- Reviews post-market surveillance data for Draeger and competitive products, including Draeger complaint data and publicly available adverse event databases (e.g. MAUDE) to anticipate potential issues and bring awareness to all appropriate stakeholders.
- Solicits input from contributing disciplines (e.g. electronics, mechanics, software, systems engineering, algorithms, product security, clinical, usability, production, service, regulatory, and user documentation) to improve product safety.
- Provides risk management guidance to other disciplines in the design process to ensure compliance with regulatory standard and guidelines.
- Assesses product non-conformities and contributes to sound rationales for deferred defects.
- Uses risk management knowledge and tools to perform risk-benefit analyses for decision making purposes.
- Provides risk management perspective and input in Health Hazard Evaluations (HHEs) that assist in more effective response to issues in the field.
- Performs other duties as needed and assigned.
Education: Bachelor’s degree in engineering or clinical discipline, Master’s degree a plus.
- 1-5 years relevant experience in risk management for medical devices or other regulated industry
- Experience in product development and post market
- Experience in the development of electro-mechanical devices with embedded software
- Experience in the field of patient monitoring and/or hospital networking
The Dräger Workplace
In North America, Draeger employees over 1,400 employees working in our major sites in the United States and Canada (in the US: Andover, MA; Telford, PA; Houston / Coppell, TX, and in Canada: Mississauga, ON), including our Sales and Service workforce employees from coast to coast.
The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.
Equal Opportunity Employer – Disability and Veteran
Who we are
Draeger is a leading international company in the fields of medical and safety technology. Whether in clinical applications, in industry, mining or emergency services: Draeger products protect, support and save lives. That's what our more than 15,000 employees have been striving for - every day for more than 130 years. Dräger - Technology for Life ®
What we offer
Additional/Voluntary Insurance; Education & Training; Health center and gym; Health Insurance; Retirement Savings; Special Assistance; Time Away; Workplace Wellness