Staff Risk Management Engineer
Milpitas Milpitas, CA 95035
Job Title: Staff Risk Management Engineer
Location: Milpitas, California, US - 95035
Job Type: Contract
Duration: 12+ Months
About Our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
A Risk Management Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
- Execute and support on-time completion of Risk Management Deliverables. Ability to support highly complex or specialized projects
- Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
- Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
- Support Risk Management / Cybersecurity activities from product Concept through product obsolescence.
- Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy
- Ensure verification and validation evidence supports the planned risk mitigation strategy
- Complete Document Change Request Reviews in a timely and objective manner
- Additional duties may be identified by functional management based on the current project/business objectives.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- To carry out day-to-day risk management activities for all marketed JJSV Devices. This includes but is not limited to:
- Facilitating Risk Management Review Meetings
- Generating and maintaining elements of the Risk Management file in line with design control and change control requirements
- Performing Issue specific risk reviews where required for issue specific product risk matters
- Directing risk management activities in relation to IEC 60601-1 for medical electrical devices
- To ensure satisfactory and timely completion of risk control activities relating to the above.
- To assist, where appropriate, in the preparation and analysis of information for the purpose of Medical Review, including the identification of potential medical risks to the JJSV business
- To support the Global Product Risk Manager in the delivery of risk management activities raised by Medical Review.
- To provide guidance and support to the JJSV Devices business in all areas of risk management.
- To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
- To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
- Bachelor level degree in Engineering or Technical Field
- Working knowledge of ISO14971
- 8+ years’ experience
- Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
- Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Prior medical device experience preferred
- Working understanding of FDA, GMP, and ISO 13485
- Working understanding of the following standards: 60601, 62304, and 62366
- Systems or clinical engineering experience
- Experience with basic statistics and/or reliability methodologies
- Project Management experience
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
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Recruiter: Jeff Kasula