Software Design Assurance Engineer II
Bracco, Eden Prairie, MN, United States
Why Join Bracco Medical Technologies?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
The
Software Design Assurance Engineer II
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.
Primary Duties & Responsibilities:
Design Assurance - Software
Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or software as a medical device (SaMD) 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 and validation activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
Lead 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.
Documents and reports defects found during testing or from post-market activities. Provides risk assessment for the defects 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.
Qualifications (Knowledge, Skills & Abilities):
Minimum
B.S. in Engineering, Computer Science, Information Systems, or similar discipline
3 - 5 years of experience in Product software applications, developer, analyst and/or QA
3+ years of experience with software validation in a medical device environment
Experience with software development methodologies
Working knowledge of the FDA Quality System Regulation, ISO 13485, the Medical Device Directive and Medical Device Regulations
Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems
Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, IPSE GAMP, ISO 14971, and other standards, regulations and guidance related to validation of software computerized systems.
Demonstrated knowledge and proficiency in quality principles and best practices
Strong collaboration skills to effectively communicate with both business and technical teams
Effective oral and written communication skills
Effective technical writing skills
Ability to work independently
Ability to travel both domestically and internationally
Preferred:
Advanced degree in Computer Science, Software Engineering, or similar discipline
ASQ CSQE (Certified Software Quality Engineer) or similar certification
Experience with Agile PLM, Jama, TrackWise and/or SAP
Demonstrated project management skills
Familiarity with SDLC processes and methodologies, especially the application of Agile methods in the development of medical device software
Experience with cybersecurity and knowledgeable in HIPAA regulations and GDPR and related data protection policies
Other:
Travel expected to be less than 15%.
Estimated Starting Salary Range: $95,000 - 104,000
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
Paid Time Off, Company Holidays & Paid Family Leave
- We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
Achieve
- Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
Live well
- We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
Evolve
- Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
Choose
- You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
The
Software Design Assurance Engineer II
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.
Primary Duties & Responsibilities:
Design Assurance - Software
Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or software as a medical device (SaMD) 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 and validation activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
Lead 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.
Documents and reports defects found during testing or from post-market activities. Provides risk assessment for the defects 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.
Qualifications (Knowledge, Skills & Abilities):
Minimum
B.S. in Engineering, Computer Science, Information Systems, or similar discipline
3 - 5 years of experience in Product software applications, developer, analyst and/or QA
3+ years of experience with software validation in a medical device environment
Experience with software development methodologies
Working knowledge of the FDA Quality System Regulation, ISO 13485, the Medical Device Directive and Medical Device Regulations
Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems
Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, IPSE GAMP, ISO 14971, and other standards, regulations and guidance related to validation of software computerized systems.
Demonstrated knowledge and proficiency in quality principles and best practices
Strong collaboration skills to effectively communicate with both business and technical teams
Effective oral and written communication skills
Effective technical writing skills
Ability to work independently
Ability to travel both domestically and internationally
Preferred:
Advanced degree in Computer Science, Software Engineering, or similar discipline
ASQ CSQE (Certified Software Quality Engineer) or similar certification
Experience with Agile PLM, Jama, TrackWise and/or SAP
Demonstrated project management skills
Familiarity with SDLC processes and methodologies, especially the application of Agile methods in the development of medical device software
Experience with cybersecurity and knowledgeable in HIPAA regulations and GDPR and related data protection policies
Other:
Travel expected to be less than 15%.
Estimated Starting Salary Range: $95,000 - 104,000
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
Paid Time Off, Company Holidays & Paid Family Leave
- We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
Achieve
- Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
Live well
- We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
Evolve
- Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
Choose
- You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.