Product Risk Manager - Andover, United States - Draeger Medical Systems, Inc.

Description

Product Risk Manager-Hybrid - Draeger Medical Systems, Inc. - Job-ID V

Andover

Vollzeit


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 productrelated 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 postmarket 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 nonconformities and contributes to sound rationales for deferred defects.
• Uses risk management knowledge and tools to perform riskbenefit 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.

Your Qualifications Education**:

Bachelor's degree in engineering or clinical discipline, Master's degree a plus.


Related Experience:

• 15 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 electromechanical devices with embedded software
• Experience in the field of patient monitoring and/or hospital networking

Special Competencies or Certifications:

• A solid understanding of the potential sources of risk and how to manage risk
• Broad technical knowledge in mechanics, electronics, software
• Proficiency with risk management tools, including FMEA, FTA and FMECA
• Knowledge of usability or human factors engineering for medical devices
• Knowledge of GMPs as defined by the FDA
• Knowledge in requirements management
• Familiarity with UL, CSA, IEC/EN and other regulatory standards
• Skilled in collaborating with multidisciplinary teams

Work Environment / Conditions:


Note:
Any physical requirements listed
must be deemed an Essential Function of the job.

• Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
• Ability to work in a fastpaced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.
• Ability to travel domestically and internationally up to 10% of the time

The Dräger Workplace
Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

The design, development and manufacturing of Draeger's Patient Monitoring product line takes place in our Andover, Massachusetts location.


EEO is the Law
Draeger is an Equal Opportunity Employer


To learn more:

Know Your Rights:
Workplace Discrimination is Illegal )

Who we are

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future.

With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.

What we offer

• Retirement savings
• Health center and gym
• Health Insurance

If you have any questions, please contact
Gwendolyn Zappala