Elucent Medicalposted 17 days ago
Eden Prairie, MN
Computer and Electronic Product Manufacturing
> Position: Senior Software Design Assurance Engineer Location: Eden Prairie, MN
Job Id: 170 # of Openings: 1
Job Title:
Senior Software Design Assurance Engineer
Department:
Quality and Regulatory
Reports to:
Vice President - Regulatory and Quality
Work Location:
In-Person
Pay Range:
Salary $100,000.00 to $130,000.00 (Based on Experience)
Position Type and Expected Hours of Work:
Full-Time, Monday-Friday, 40 hours/week
About Elucent Medical:
Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.
Job Summary:
As a Senior Software Design Assurance Engineer, you will play a critical role in ensuring the quality, safety, and compliance of medical device software throughout its lifecycle. Acting as the primary quality liaison within the software development process, you will collaborate closely with cross-functional teams, including Development, Operations, and Regulatory Affairs, to support test strategy formulation, perform comprehensive design documentation reviews, and ensure alignment with industry standards such as IEC 62304, FDA guidance, and internal quality policies. You will also lead efforts in post-market surveillance by analyzing software-related product issues, conducting root cause investigations, and driving effective corrective actions. Your contributions will be instrumental in shaping data-driven and risk-based decisions that enhance product quality, patient safety, and customer satisfaction.
Supervisory Responsibilities:
None.
Job Responsibilities:
Provide direction to software and product development teams regarding conformance to product requirements associated to electromechanical medical devices containing software.
Drive the Design Control process relative to software within the framework of regulatory requirements.
Assure specifications and requirements are relevant, capable, and meet applicable standards, and that all requirements are suitably testable and verified.
Provide direction and support, and, if appropriate, manage design verification activities.
Assess protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and quality of the test specifications.
Lead security risk management activities from planning, analysis, verification, risk reporting and acceptance for the assigned areas of responsibility.
Manage the software QA deliverables including reviewing and providing input to meet the project scope and plan.
Work with external design/test organizations to ensure software design control requirements are fulfilled and appropriate supplier controls are in place.
Documents and reports defects found during testing and through post-market surveillance; 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.
Manage and lead the medical device cybersecurity process to ensure compliance with regulatory requirements.
Manage non-product software validation efforts including internal software tools.
Qualifications
Education and Experience:
Minimum 3-5 years of work experience in medical device product software applications.
Minimum 3 years of work experience in software quality assurance, preferred.
BS degree in engineering, mathematics, computer science, software development or other technical field is required.
Demonstrated experience in application of software development methodologies and standards including IEC 62304, ISO 62366, AAMI TIR 36, SW96, TIR-57 etc.
Knowledge and experience with software cybersecurity including security risk assessments, SBOMs, threat monitoring and penetration testing is required.
Demonstrated knowledge and experience authoring design verification and validation protocols and reports.
Experience working in software development tools such as MS Visual Studio is required.
Knowledge and/or experience with medical device quality management systems including 21 CFR Part 820 and ISO 13485.
ASQ CSQE (Certified Software Quality Engineer) preferred.
Required Skills/Abilities:
Individual must have a hands-on approach.
Strong organizational and time management skills.
Recognized as a technical leader within the company and maintains positive attitude when working with peers, customers or suppliers.
Works effectively on cross functional teams to establish appropriate processes pertaining to quality.
Excellent written and oral communication skills.
Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies.
Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations.
Physical Requirements / Work Conditions:
Prolonged periods of sitting at a desk and working on a computer (up to 8 hours per day)
Ability to use hands and fingers to operate a keyboard, mouse, and other office equipment
Frequent viewing of a computer screen
Occasional reaching, bending, or lifting of light objects (typically under 15 pounds)
Standard office environment with controlled temperature and lighting
Elucent Medical Benefits, Culture and Work Environment
At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.
Fulltime Employees are provided:
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs
Affirmative Action / EEO Statement
Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Job Id: 170 # of Openings: 1
Job Title:
Senior Software Design Assurance Engineer
Department:
Quality and Regulatory
Reports to:
Vice President - Regulatory and Quality
Work Location:
In-Person
Pay Range:
Salary $100,000.00 to $130,000.00 (Based on Experience)
Position Type and Expected Hours of Work:
Full-Time, Monday-Friday, 40 hours/week
About Elucent Medical:
Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.
Job Summary:
As a Senior Software Design Assurance Engineer, you will play a critical role in ensuring the quality, safety, and compliance of medical device software throughout its lifecycle. Acting as the primary quality liaison within the software development process, you will collaborate closely with cross-functional teams, including Development, Operations, and Regulatory Affairs, to support test strategy formulation, perform comprehensive design documentation reviews, and ensure alignment with industry standards such as IEC 62304, FDA guidance, and internal quality policies. You will also lead efforts in post-market surveillance by analyzing software-related product issues, conducting root cause investigations, and driving effective corrective actions. Your contributions will be instrumental in shaping data-driven and risk-based decisions that enhance product quality, patient safety, and customer satisfaction.
Supervisory Responsibilities:
None.
Job Responsibilities:
Provide direction to software and product development teams regarding conformance to product requirements associated to electromechanical medical devices containing software.
Drive the Design Control process relative to software within the framework of regulatory requirements.
Assure specifications and requirements are relevant, capable, and meet applicable standards, and that all requirements are suitably testable and verified.
Provide direction and support, and, if appropriate, manage design verification activities.
Assess protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and quality of the test specifications.
Lead security risk management activities from planning, analysis, verification, risk reporting and acceptance for the assigned areas of responsibility.
Manage the software QA deliverables including reviewing and providing input to meet the project scope and plan.
Work with external design/test organizations to ensure software design control requirements are fulfilled and appropriate supplier controls are in place.
Documents and reports defects found during testing and through post-market surveillance; 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.
Manage and lead the medical device cybersecurity process to ensure compliance with regulatory requirements.
Manage non-product software validation efforts including internal software tools.
Qualifications
Education and Experience:
Minimum 3-5 years of work experience in medical device product software applications.
Minimum 3 years of work experience in software quality assurance, preferred.
BS degree in engineering, mathematics, computer science, software development or other technical field is required.
Demonstrated experience in application of software development methodologies and standards including IEC 62304, ISO 62366, AAMI TIR 36, SW96, TIR-57 etc.
Knowledge and experience with software cybersecurity including security risk assessments, SBOMs, threat monitoring and penetration testing is required.
Demonstrated knowledge and experience authoring design verification and validation protocols and reports.
Experience working in software development tools such as MS Visual Studio is required.
Knowledge and/or experience with medical device quality management systems including 21 CFR Part 820 and ISO 13485.
ASQ CSQE (Certified Software Quality Engineer) preferred.
Required Skills/Abilities:
Individual must have a hands-on approach.
Strong organizational and time management skills.
Recognized as a technical leader within the company and maintains positive attitude when working with peers, customers or suppliers.
Works effectively on cross functional teams to establish appropriate processes pertaining to quality.
Excellent written and oral communication skills.
Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies.
Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations.
Physical Requirements / Work Conditions:
Prolonged periods of sitting at a desk and working on a computer (up to 8 hours per day)
Ability to use hands and fingers to operate a keyboard, mouse, and other office equipment
Frequent viewing of a computer screen
Occasional reaching, bending, or lifting of light objects (typically under 15 pounds)
Standard office environment with controlled temperature and lighting
Elucent Medical Benefits, Culture and Work Environment
At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.
Fulltime Employees are provided:
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs
Affirmative Action / EEO Statement
Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
