The Device Engineering Lifecycle Management Risk Lead is responsible for global Medical Device and Combination Product lifecycle management including product and process change management and risk management. Responsible to maintain compliance between the on-market product and the Design History File (DHF). Cross divisional and PGS Site facing role to establish activity priority and communicate deliverables and timing. This position, will partner with clinical affairs, medical affairs, safety, quality, and the manufacturing site colleagues in the assessment of patient, product, and process risk.
Provide technical guidance for device changes, document updates, process changes, risk management
Expert in risk analysis and risk management tools, techniques, and methodologies
Facilitate patient risk assessment and rationale with key medical, clinical, safety, quality, and site stakeholders
Create and plan risk assessment activities, track progress, and communicate status to management
Train PGS site, clinical, medical, and safety colleagues on product and process risk management activities for product lifecycle
Accountable for the risk management for products and deployment / maintenance of risk management review process
Facilitate marketed product maintenance process with clear roles and responsibilities for Center functions, Site, Quality, Engineering, and R&D functional units
Develop and manage network-wide project prioritization
Support technical issue resolution associated with medical device and combination product risk assessments
Support day to day support for design changes, complaints, CAPA, management review
Report and escalate to leadership as needed
Communicate technical risks to key stakeholders at production sites and within central functions
Establish and maintain relationships with production sites and key stakeholders
Ability to effectively manage and influence global cross functional teams
Bachelor s degree in Packaging, Mechanical, Chemical, Biomedical or related Engineering Science is required. Advanced degree desirable.
10 years experience in Device Design, Quality Engineering, Pharmaceutical Package Engineering, Package Design or equivalent Technical Project Management preferred
5 years experience in Medical Device and Combination Products Design Controls, Production, Sustaining Engineering role, Risk management or related field preferred
Practical application of Risk Management tools
Practical application of analyzing complex issues for patient/user impact
Thorough understanding and in-depth knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
Practical expertise in production and production systems in a GMP regulated environment
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
Expert technical expertise in risk management and associated tools for patient, user, design, and process risks
Proven project management and complex problem solving skills
Excellent relationship management, communication and presentation skills
Excellent verbal, written and interpersonal communication skills
Demonstrated ability to plan, implement, and achieve significant, complex goals and objectives
Demonstrated leadership with proven success in challenging status quo
Strong organizational and planning skills, as well as a high energy level and initiative
Ability to work independently and as a member of a team and in collaboration with other functional groups
Strong technical knowledge of complex Medical Device and Combination Products technologies
Ability to advance new processes and moderately complex methodologies
Agile learner of new processes and capable of developing / executing again immature processes
Strong technical project manager, critical thinking, and problem solving skills
Office-based role supporting virtual teams via webex and phone. Flexibility required when working with global colleagues in various time zones.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to travel up to 30%
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EEO & Employment Eligibility
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