Beacon BiosignalsRemote
Director, Quality Engineering
United States
Full-time
1 week ago
$195,000 - $215,000 USD
H1B Sponsor Likely
Key skills
Quality Engineering LeadershipRegulatory Compliance ExpertiseMedical Device Industry ExperienceSoftware Tool ValidationProcess ImprovementAnalytical SkillsTeam ManagementCommunication SkillsTeam Capability BuildingStakeholder ManagementEuropean Regulatory KnowledgeCertified Software Quality EngineerCertified Quality EngineerInterpersonal SkillsMentoring SkillsProject ManagementAdaptabilityMachine LearningLeadershipMentoringCommunicationCollaboration
About this role
Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. The Director of Quality Engineering is responsible for leading a team of Quality Engineers and serving as a strategic technical leader and compliance partner to engineering leadership, ensuring regulatory compliance and process improvements in product development.
Responsibilities:
- Supervise and develop a team of Quality Engineers, coordinating their activities to support company and departmental goals
- Build team capability through mentoring, coaching, and fostering technical expertise in regulated medical device development
- Manage workload distribution and prioritization across multiple concurrent projects and initiatives
- Drive performance management, providing regular feedback and creating development opportunities
- Partner with engineering leadership to guide Software, Machine Learning, and Hardware teams through new product development and sustaining engineering
- Champion the least burdensome approach to compliance while maintaining regulatory integrity
- Drive process improvements across the quality management system to enhance efficiency and effectiveness
- Represent Quality in executive-level discussions, audits, and regulatory interactions
- Serve as SME for hardware and software compliance processes across design, manufacturing, product release, and post-market support
- Lead product release coordination in collaboration with engineering and manufacturing teams
- Oversee Software Tool Validation program to meet regulatory and operational requirements
- Represent Beacon in second-party (customer) and third-party audits (ISO auditors) and regulatory inspections
- Drive MDR compliance and CE marking initiatives for Beacon products
- Stay current on international standards and regulations, ensuring organizational awareness
- Act as quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control
- Ensure timely project delivery on time, within scope, and in compliance with all regulatory requirements
Requirements:
- Minimum 10 years of combined software and hardware quality experience in medical device industry
- Previous experience managing teams of Quality Engineers, including performance management, mentoring, and development
- Proven ability to coordinate team activities and delegate effectively based on competency and workload
- Track record of developing direct reports and building team capability
- Experience managing competing priorities across multiple projects and teams simultaneously
- Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders
- Expert knowledge of key industry standards and regulations: 21 CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, ISO 14971
- Demonstrated experience implementing IEC 62304
- Bachelor's degree in a relevant scientific, engineering, or related field
- Knowledge of European regulatory requirements (IVDR/MDR), including CE mark process
- Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances
- Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) - required