Tactile Medical
Principal Design Assurance Engineer
New Brighton, Minnesota · Principal
Sponsorship not specified$116k-$173kDetected 6 days ago
Data AnalysisProduct ManagementProcess ImprovementMechanical DesignElectrical EngineeringFDA RegulatoryMedical DevicesLeadershipCommunicationMentoringRegulatory Affairs
About the role
- Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.
Responsibilities
- Serve as the Design Assurance subject matter expert for New Product Introduction programs
- Establish Design Assurance strategies, quality plans, and risk-based approaches for product development and lifecycle management
- Own quality system processes for Design Control, Risk Management, and Product Development processes
- Serve as reviewer and approver for critical design control deliverables and major design decisions
- Lead design verification and validation strategies, including usability validation, and statistical justification of testing approaches
- Lead cross-functional quality initiatives with organization-wide impact and contribute to strategic planning and capability development
- Prior experience mentoring engineers, leading quality capability-building initiatives, or influencing quality strategy across a matrixed organization
- Demonstrated ability to lead through influence without direct authority.
- Demonstrated ability to lead multiple highly complex technical initiatives simultaneously.
Requirements
- Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, or related technical discipline required
- Knowledge & Skills
- Advanced knowledge of statistical methods, reliability engineering, validation methodologies, and data analytics
- Strong business acumen with the ability to balance risk, compliance, and business objectives
- Proven mentoring and leadership capabilities.
- Ability to translate regulatory and quality requirements into scalable business processes.
Compensation
- Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insu
Benefits
- Lead design assurance activities throughout the product lifecycle from concept through commercialization, sustaining engineering, and product retirement.
- Experience serving as a design assurance or quality lead for electromechanical, software-enabled, or connected medical device products
- Expert knowledge of Design Controls, Risk Management, and Product Realization for medical devices
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This listing is sourced directly from Tactile Medical's careers page and normalized into a canonical job model.