Sr. Design Assurance Engineer

Position Summary :

The Sr. Design Assurance Engineer position will support design assurance activities for Bracco Medical Technologies (BMT) products.

This role is responsible for providing support for Design Verification and Validation activities while ensuring compliance to BMT design control procedures and applicable regulations and external standards.

This role will act as Subject Matter Expert for Biocompatibility, Micro-biology, Packaging, and Sterilization to support new product development as well as commercialized products.

Manages critical projects for the organization ensuring efficient and effective project reporting and closure. Main focus area includes consumable medical devices for single and multi-use applications.

Primary Duties & Responsibilities :

Design Assurance

• Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated with consumable products.
• Drive the Design Control process and own the Design History File (DHF) within the framework of regulatory requirements.
• Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
• Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
• Support risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
• Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
• Generate the QA deliverables to meet the project scope and plan.
• Review, provide input, and approve project-related deliverables and change orders.
• Work with external design / test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
• Provide project teams subject matter expertise as it applies to biocompatibility, sterilization, and chemical analysis for Extractable and Leachables, particulates, and multi-use testing.
• Documents and reports defects found during testing and works with the development team to ensure they are resolved.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.

S. and non U.S. product and safety standards.

• Rigorous documentation for all phases of new product development including specifications, verification test plans, biocompatibility assessments, sterilization protocols, and change orders associated with medical devices and consumable products.
• Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Maintain project plans, set / adhere to milestones, deliverables and budgets, and manage a limited number of concurrent projects.
• Ensure that all deliverables are clearly communicated to management including planning, deliverables and timing and defined objectives.
• Direct outside contract personnel / suppliers / laboratories as needed for completion of specific tasks.

Product Quality Engineering Support

• Develop and maintain Quality Plans for sustaining and development projects to ensure compliance with established policies, regulations, and customer & design requirements.
• Act as a SME for Biocompatibility, Chemistry, and Microbiology for new product development and ongoing sustaining projects
• Work with and manage external laboratory testing including generation of statement of work (SOW) within the project team
• Provide leadership and QA support for CAPA activities relating to products and process, and leading other efforts relating to quality characteristics and conformance to product requirements.
• Review and approve change orders related to product / process changes.
• Participate in internal / external audits as needed.
• Evaluate corrective actions for effectiveness to assure conformity to quality specifications.
• Provide leadership and QA support for validation of production and test processes.
• Provides mentorship to other Quality Engineers on an as needed basis.

Required Skills

Minimum :

• B.S. in Engineering (chemical or chemistry) or comparable science discipline; Masters preferred.
• Minimum 5+ years of Quality Engineering experience in medical device industry, preferably with sterile consumables.
• Extensive knowledge of process validation, test method validation and R&R study
• Extensive knowledge of biocompatibility, microbiology, and sterilization methodologies
• Extensive knowledge of and effective application of quality tools (e.g., Six Sigma, DOE, process analysis / capability, FMEA, FTA)
• Extensive knowledge with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820
• Extensive knowledge of risk management and ISO14971
• Strong written and verbal communication skills to effectively translate ideas, concepts and information
• Ability to develop clear, concise, and timely oral and written reports
• Ability to support critical projects that requires advanced problem solving skills and project management oversight
• Ability to work independently
• Ability to travel both domestically and internationally

Preferred :

• Advanced degree-Engineering or Chemistry
• 7-10 yrs experience, with specific experience in Design Assurance
• Demonstrated project management skills in order to plan, conduct and implement system assessments
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Knowledge of IEC 60601 and UL Standards
• Knowledge of USP testing and standards

Other :

Travel expected to be less than 15%.

Required Experience

Minimum :

• B.S. in Engineering (chemical or chemistry) or comparable science discipline; Masters preferred.
• Minimum 5+ years of Quality Engineering experience in medical device industry, preferably with sterile consumables.
• Extensive knowledge of process validation, test method validation and R&R study
• Extensive knowledge of biocompatibility, microbiology, and sterilization methodologies
• Extensive knowledge of and effective application of quality tools (e.g., Six Sigma, DOE, process analysis / capability, FMEA, FTA)
• Extensive knowledge with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820
• Extensive knowledge of risk management and ISO14971
• Strong written and verbal communication skills to effectively translate ideas, concepts and information
• Ability to develop clear, concise, and timely oral and written reports
• Ability to support critical projects that requires advanced problem solving skills and project management oversight
• Ability to work independently
• Ability to travel both domestically and internationally

Preferred :

• Advanced degree-Engineering or Chemistry
• 7-10 yrs experience, with specific experience in Design Assurance
• Demonstrated project management skills in order to plan, conduct and implement system assessments
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Knowledge of IEC 60601 and UL Standards
• Knowledge of USP testing and standards

Other :

• Travel expected to be less than 15%.
1 day ago