Manager, Design Assurance

About the role

This Design Assurance Manager position will oversee a team of engineers supporting new product development and sustaining products, ensuring that products are designed, tested, and manufactured to the highest levels of customer quality. This role will support a growing business to meet new challenges through talent development, resource management, and technical leadership.

Responsibilities

• Manages the Design Assurance staff’s day to day activities by setting clear objectives, while working with leadership to improve individual and team engagement.
• Provides technical and project leadership.
• Maintains and employs extensive integrated knowledge of products, Medical Device Quality Regulations, Compliance and Safety.
• Promotes learning, development, and knowledge transfer.
• Foster an environment that drives continuous improvement and maintains compliance throughout the organization.
• Captures and communicates lessons learned while acting as an agent of change across the organization.
• Champions opportunities to implement new tools, technologies, and methods to improve organizational processes.
• Establish a strong network and cross-functional collaboration within the organization.
• Recruit, lead, mentor, and develop team members.
• Lead the performance management process to provide feedback, recognize high performance and provide professional development opportunities.

Requirements

• 8+ Years Experience with Bachelor's Degree
• 5+ Years Experience with Master’s Degree
• 3+ Years Experience with PhD
• Experience with Oracle ERP System or Agile Product Lifecycle Management System is beneficial.
• Advanced knowledge of FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality Management System, ISO 149721:2019, Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive, Regulation (EU) 20177/745 (MDR) European Union Medical Device Regulation
• Advanced knowledge of Risk Management
• Advanced knowledge or requirements analysis, including development of testable and measurable specifications.
• Strong ability to assess and analyze written product and teams and manage success factors.
• Strong ability to effectively present information and respond to questions from all level of the organization.
• Demonstrated ability to develop and lead a high performing team; effectively manage direct reports and projects; strong mentoring and coaching skills.
• Demonstrated ability to lead large and complex projects.
• Excellent verbal and written communication skills with ability to communicate with both technical and non-technical peers and management.
• Proficient in Microsoft Office
• Bilingual is beneficial.
• ASQ Certified Quality Engineer is beneficial.
• Six Sigma Certification is beneficial.

Qualifications

• Advanced knowledge of verification and validation requirements for a regulated product.
• Strong ability to effectively present information and respond to questions from all level of the organization.
• Demonstrated ability to develop and lead a high performing team; effectively manage direct reports and projects; strong mentoring and coaching skills.
• Demonstrated ability to lead large and complex projects.
• Excellent verbal and written communication skills with ability to communicate with both technical and non-technical peers and management.
• Proficient in Microsoft Office
• Bilingual is beneficial.
• ASQ Certified Quality Engineer is beneficial.
• Six Sigma Certification is beneficial.

Skills

• Advanced knowledge of Risk Management
• Advanced knowledge or requirements analysis, including development of testable and measurable specifications.
• Strong ability to assess and analyze written product and teams and manage success factors.
• Strong ability to effectively present information and respond to questions from all level of the organization.
• Proficient in Microsoft Office

Benefits

The annualized base salary range for this role is $122,000 to $200,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Pay

The annualized base salary range for this role is $122,000 to $200,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Schedule

Not specified.