Staff Product Risk Manager

The Job Responsibilities

We are looking for a Staff Product Risk Manager to work hybrid in our Andover, MA location.

The Staff Product Risk Manager Provides risk management expertise and leadership throughout the product development life cycle in accordance with internal processes and external standards.

Responsibilities:

• Leads cross functional teams though the risk management process throughout the development cycle, ensuring that risks are identified, control measures are defined, verified and effective, in accordance with ISO 14971 and Draeger processes.
• Creates and maintains product-related files and reports 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 to anticipate potential issues and bring awareness to all appropriate stakeholders.
• Provides leadership and expertise to product development teams at a system level and within engineering disciplines to ensure risk management principles are applied throughout the design process.
• Collaborates with contributing disciplines including electronics, mechanics, software, systems engineering, algorithms, product security, clinical, usability, production, service, and regulatory to ensure risk activities are effectively and efficiently coordinated.
• Applies advanced technical knowledge and skill to influences product or system architecture and design resulting in improved product safety.
• Assesses product non-conformities and provides sound risk/benefit rationale for deferred defects.
• Provides product risk expertise input to improve responses to issues in the field; performs risk-benefit analysis and assesses and improves the risk management process resulting in improved overall product safety.
• Performs other duties as needed and assigned.

Your Qualifications

• Bachelor’s degree in engineering or clinical discipline, Master’s degree a plus.
• 8+ years experience in medical device design
• 5+ years relevant experience in risk management for medical devices or other regulated industry
• Experience in the field of patient monitoring or other complex medical devices
• A solid understanding of the potential sources of risk and how to manage risk
• Broad technical knowledge in mechanics, electronics, software
• Knowledge of usability or human factors engineering for medical devices
• Knowledge in requirements management
• Familiarity with UL, CSA, IEC/EN and other regulatory standards
• Skilled in collaborating with multi-disciplinary multi-national teams

Pay Transparency

The targeted pay range for this position is typically between $122,000 - $146,600. We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job-related knowledge, skills, experience, and other objective business considerations.​ This position is eligible for the following additional compensation: annual bonus.