Werfen North America · 2 weeks ago
Senior Manager, Risk Management Process
Bedford, MA
Full-time
Onsite
Senior Level, Lead/Staff
$160K/yr - $190K/yr
17+ years expWerfen North America is a family-owned, innovative company specializing in diagnostics. The Sr. Manager-Risk Management Process is responsible for managing risk processes throughout the product lifecycle, ensuring compliance with ISO 14971 standards, and collaborating with cross-functional teams to enhance product quality and reliability.
Health CareManufacturing
Responsibilities
Lead cross functional discussions with various R&D and other cross functional design team members to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented
Monitors that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle
Leads periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with quality systems and ensuring compliance with regulatory standards and practices
Leads remediation efforts for updating risk management documents and the implementation of the various risk processes
Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing the firm’s risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods
Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with Werfen’s strategic objectives
Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members
Identify opportunities for continuous improvement of the Risk Management Process
Supports R&D projects with software elements and software tools according to corporate priorities to ensure compliance with procedures and regulations
Support validation and modifications for software used in the production of Werfen products
Lead internal and external audits for risk-related matters, ensuring compliance with regulatory requirements and industry standards
Collaborate with software, manufacturing, R&D, and others as required to recommend or implement corrective and preventive actions (CAPA)
Ensure department targets are consistently met or exceeded through the application of best available manufacturing and development practices
Develop appropriate software quality metrics to identify issues or trends in a timely manner
Lead improvements to key elements of the Quality Management System that supports long term plans to maximize effectiveness and scalability
Ensure department targets are consistently met or exceeded through the application of best available manufacturing and development practices
Make recommendations to management to ensure continued adequacy, suitability, and effectiveness of the QMS
Lead the Risk team with overall management responsibilities, including hiring, goal setting, professional development, mentoring, training, and performance assessment
Deploy technically proficient Risk Quality Engineers to provide quality engineering-based deliverables, including software validation, software risk management, testing methodologies, and compliance with regulatory standards
Establish and manage department budget
Perform other duties as assigned
Facilitate and provide ongoing training on standards/processes as needed to other associates or functions
Assist with strategic initiatives and planning
Mentor and coach other members on the team and cross functional teams on risk management processes
Qualification
Required
Bachelor's degree in engineering, Quality Management, Risk Management, or a related field
Minimum of seventeen (17) years of experience, or thirteen (13) years with advance degree, within a regulated medical device or pharmaceutical environment
Minimum of five years of risk management experience in the medical device industry, preferably in patient monitoring systems
Minimum of Five (5) years previous supervisory/management experience required
Superior knowledge & application of ISO 14971 and TIR 24971 principles
Experience with Systems Engineering-driven processes for ISO 14971 compliance
Must be able to demonstrate successes in quality and process improvements, within a medical device or pharmaceutical environment strongly preferred
Expert knowledge of quality engineering principles including risk management, software reliability engineering, software validation, root cause investigation, process validation, process capability, trend analysis, statistical methods and metrology
Excellent project management and problem-solving skills
Strong planning, analytical, organizational and time management skills are required
Able to lead and guide a Validation Review Board to implement validation best practices
Strong leadership abilities required with a focus on collaboration and teamwork
Expert knowledge of US, EU, and international regulations and guidance documents regarding software for medical devices and IVDs, including compliance requirements, validation standards, and cybersecurity considerations
Strong understanding of stakeholder requirements, design inputs/outputs, and hazardous situation analysis
Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including Software Development, AGILE, quality control, manufacturing and design engineering
Computer literacy required; knowledge of Microsoft Office, experience with large enterprise resource planning (ERP) system and statistical software required
Strong communication skills to all levels of the organization is required (verbal, written, listening and presentation)
Preferred
Master's degree in engineering, Quality Management, Risk Management, or a related field is preferred
ASQ Certified CSQE, SSBB, CQE or SQE preferred
QMS lead auditor certificate preferred
Experience with JAMA or other relational databases for requirements management is strongly preferred
Benefits
Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation
Sick leave
Performance-based bonus
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
Company data provided by crunchbase