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Senior Principal Software Development & Compliance Engineer – CRM
| Company | Medtronic |
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| Location | Blaine, MN, USA |
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| Salary | $169600 – $254400 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Expert or higher |
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Requirements
- Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
- Minimum of 10 years of experience with Software Verification and/or Test Systems Development, or advanced degree with a minimum of 8 years of technical experience.
Responsibilities
- Maintain and optimize software development processes for a complex, cross-functional organization engaged in medical device software development.
- Ensure the development process remains compliant with industry regulations and standards, updating policies as new guidelines become effective.
- Ensure the software development process is aligned with the overall product development process and other relevant policies and processes (e.g. security, privacy).
- Guide teams through regulatory landscapes to ensure that design processes align with quality standards and mitigate risks during the product lifecycle.
- Drive initiatives to create a culture of continuous improvement by regularly assessing and evolving development practices.
- Serve as a strategic advisor to cross-functional stakeholders, influencing design control processes and providing expertise on product development SOPs.
- Develop and deliver training on development processes, regulatory compliance, and industry best practices.
- Conduct audits of design history files to ensure compliance with internal processes, regulatory standards, and industry guidelines.
- Monitor regulatory changes and proactively update internal processes to ensure ongoing compliance.
- Establish compliance metrics, monitor performance, and report findings to relevant stakeholders.
Preferred Qualifications
- Strong understanding of design controls, regulatory frameworks, and quality standards.
- Experience working with Agile methodologies, managing multiple scrum teams, and navigating complex, cross-functional environments.
- Sound experience and thorough knowledge of FDA 21/CFR Part 820, ISO 13485, and IEC 62304.
- Excellent written and verbal communication skills; ability to present information to cross functional audiences and management.
- Experience auditing design history files and implementing industry best practices.
- Ability to monitor, interpret, and implement changes in regulatory requirements efficiently.
- Lean Six Sigma Black Belt certified.
- Technical degree is a plus.
- Proven experience leading software development processes in a highly regulated industry, ideally within medical devices or similar fields.
- Experience with Design Control documentation within medical device industry or Pharma industry.
- Experience conducting and organizing training, mentoring, and guidance for cross functional teams through design control and regulation requirements.
- Ability to influence stakeholders, drive process improvements, and develop strategic initiatives aligned with business goals.
- Subject matter expert in all phases of product development lifecycle (design input/output and V&V).
- High degree of initiative and self-motivation.
- Expertise in change management and leading organizational transformation.
- Experience with Risk Management in medical devices is an advantage.
