SurModics
Principal Design Assurance Engineer
Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company's expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Responsibilities
Product Development Team Member Serve as DA Lead (Core Team Member) on cross-functional PDP team Provide subject matter expertise and leadership in the area of Design Controls and Risk Management Understand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologies Lead execution of risk management activities for PDP projects Develop Design Verification, Design Validation, and Usability plans, protocols and reports Develop and execute or oversee test method validations Plan post market activities for the project through development of PMS Plan, Field Assessment Plan and support of Clinical Evaluation, clinical literature review and PMCF studies Understand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies. Lead problem solving activities, failure investigations, and CAPA activities Support design transfer activities including process validation and material qualifications. Serve as project manager for the project or specific area of the project, if requested. Provide subject matter expertise for assigned projects in audits Balance complex performance, regulatory, and manufacturing requirements to achieve most optimal solution for the project. Management Develops and maintains a solid team environment through effective hiring, communication, recognition, feedback and development Working manager that both manages the team and serves a design assurance function for assigned teams or projects Monitors, directs, and prioritizes staff workload to ensure business objectives are met Contributes to establishing overall Quality department yearly goals and objectives Advises planning for department resource needs Foster a department culture of pertaining to Surmodics mission and 5C values Responsible as primary interface for internal audits, regulatory body audits for responsible areas Determine appropriate staff levels and schedules while working with key partners to understand priorities and plan resource allocation accordingly Provides mentoring and coaching for less experienced staff Post Market Lead planning and facilitate execution of post market surveillance activities Lead complaint investigations in the categories of risk assessment investigations Generate Field Assessment and Post Market Surveillance reports Analyze engineering change requests Support process and design change activities Address regulatory standards gap assessments to maintain product compliance Quality Systems Drive improvements to the design control, post-market surveillance, risk management, and any other assigned processes to ensure ongoing compliance Develop and maintain key quality metrics and drive improvements Develop risk-based procedures and instructions throughout the quality system Present trending data to management during management review Review current regulations and requirements and recommend changes to quality system Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs Minimum Qualifications
BS or advanced degree in technical discipline, engineering preferred 3+ years management experience 8+ years overall medical device experience 8+ years' experience in DA or Quality Engineering function Extensive experience with QSR and ISO regulations Extensive experience with statistical techniques, measurement/trending and SPC tools Demonstrated technical expertise and leadership in Quality Strong ability to communicate (written and verbally) within and across disciplines and organizational structures Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment Self-starter, with the ability to manage multiple tasks and tight timelines Demonstrated use of tools and methodologies within a Quality System High attention to detail, organization, and accuracy Excellent analytical and problem solving skills Proficient computer skills- Microsoft Word, Access and Excel, statistic software(jmp, minitab)
Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company's expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Responsibilities
Product Development Team Member Serve as DA Lead (Core Team Member) on cross-functional PDP team Provide subject matter expertise and leadership in the area of Design Controls and Risk Management Understand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologies Lead execution of risk management activities for PDP projects Develop Design Verification, Design Validation, and Usability plans, protocols and reports Develop and execute or oversee test method validations Plan post market activities for the project through development of PMS Plan, Field Assessment Plan and support of Clinical Evaluation, clinical literature review and PMCF studies Understand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies. Lead problem solving activities, failure investigations, and CAPA activities Support design transfer activities including process validation and material qualifications. Serve as project manager for the project or specific area of the project, if requested. Provide subject matter expertise for assigned projects in audits Balance complex performance, regulatory, and manufacturing requirements to achieve most optimal solution for the project. Management Develops and maintains a solid team environment through effective hiring, communication, recognition, feedback and development Working manager that both manages the team and serves a design assurance function for assigned teams or projects Monitors, directs, and prioritizes staff workload to ensure business objectives are met Contributes to establishing overall Quality department yearly goals and objectives Advises planning for department resource needs Foster a department culture of pertaining to Surmodics mission and 5C values Responsible as primary interface for internal audits, regulatory body audits for responsible areas Determine appropriate staff levels and schedules while working with key partners to understand priorities and plan resource allocation accordingly Provides mentoring and coaching for less experienced staff Post Market Lead planning and facilitate execution of post market surveillance activities Lead complaint investigations in the categories of risk assessment investigations Generate Field Assessment and Post Market Surveillance reports Analyze engineering change requests Support process and design change activities Address regulatory standards gap assessments to maintain product compliance Quality Systems Drive improvements to the design control, post-market surveillance, risk management, and any other assigned processes to ensure ongoing compliance Develop and maintain key quality metrics and drive improvements Develop risk-based procedures and instructions throughout the quality system Present trending data to management during management review Review current regulations and requirements and recommend changes to quality system Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs Minimum Qualifications
BS or advanced degree in technical discipline, engineering preferred 3+ years management experience 8+ years overall medical device experience 8+ years' experience in DA or Quality Engineering function Extensive experience with QSR and ISO regulations Extensive experience with statistical techniques, measurement/trending and SPC tools Demonstrated technical expertise and leadership in Quality Strong ability to communicate (written and verbally) within and across disciplines and organizational structures Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment Self-starter, with the ability to manage multiple tasks and tight timelines Demonstrated use of tools and methodologies within a Quality System High attention to detail, organization, and accuracy Excellent analytical and problem solving skills Proficient computer skills- Microsoft Word, Access and Excel, statistic software(jmp, minitab)