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Our mission is to improve human health by enabling rapid, targeted interventions through advanced brain analytics.
Director, Quality Engineering
Location
Massachusetts
Posted
133 days ago
Salary
0
Seniority
Lead
Job Description
Director, Quality Engineering
Beacon Biosignals
• 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
Job 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.
Benefits
- PTO
- equity and other benefits
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