Surmodics, Inc.
Overview
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Design Assurance Manager
role at
Surmodics, Inc. .
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 Management
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
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.
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)
Compensation and Benefits Targeted Salary Range: $112,500—$168,600 USD
Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.
Equal Employment Opportunity Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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Design Assurance Manager
role at
Surmodics, Inc. .
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 Management
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
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.
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)
Compensation and Benefits Targeted Salary Range: $112,500—$168,600 USD
Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.
Equal Employment Opportunity Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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