Beacon Biosignals - Director, Quality Engineering
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Requirements
• Minimum 10 years of combined software and hardware quality experience in the medical device industry. • Previous experience managing teams of Quality Engineers, including performance management. • 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. • 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.
Responsibilities
• 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 • The salary range for this role is $195,000 – $215,000. Salary ranges are determined using current market compensation data for this role and adjusted based on experience, skills, and location. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits. • At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.
Benefits
• Flexible work schedule with the possibility to telecommute up to two days a week. • Comprehensive health and wellness program that includes gym memberships and onsite fitness classes. • Annual performance bonuses based on individual, team, and company achievements. • Competitive salary package commensurate with experience in the medical device industry. • Opportunities for professional development through internal training programs and external courses relevant to quality engineering roles. • Access to a mentorship program designed to enhance career growth within Beacon Biosignals. • Generous vacation policy allowing up to 20 days of paid leave per year, with additional personal time off available upon request.
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