Manager, Design Assurance

Hologic Careers•Marlborough, MA

4h•$122,000 - $200,000

About The Position

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. This is a unique opportunity with the Hologic Quality team to advance the state of women's health! 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. What to expect: Manages a team of Design Assurance Engineers to develop, implement and maintain technical quality assurance and control systems and activities. Responsible for the implementation of standards, methods, and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Ensures safety and effectiveness are designed into and maintained in medical devices, through expertise in design control, risk management, quality systems and change management. Evaluates final results of new product development and on-market projects to assure accomplishment of technical objectives. Prepares and presents reports outlining the outcome of technical projects and makes recommendations for actions necessary to achieve desired results. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates to meet schedules and/or resolve technical problems. Develops and administers schedules, performance requirements; may have budget responsibilities. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Provides guidance to subordinates within the latitude of established company policies. Recommends changes to policies and establishes procedures that affect immediate organization(s). Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing. In some instances, this manager may be responsible for a functional area and not have any direct reports. What we expect: 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. Drives and challenges the organization to achieve “state of the art” practices. 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
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
Advance knowledge of verification and validation requirements for a regulated product
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
Must follow all applicable FDA regulations and ISO requirements.

Nice To Haves

Experience with Oracle ERP System or Agile Product Lifecycle Management System is beneficial.
Bilingual is beneficial.
ASQ Certified Quality Engineer is beneficial.
Six Sigma Certification is beneficial.

Responsibilities

Manages a team of Design Assurance Engineers to develop, implement and maintain technical quality assurance and control systems and activities.
Responsible for the implementation of standards, methods, and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
Ensures safety and effectiveness are designed into and maintained in medical devices, through expertise in design control, risk management, quality systems and change management.
Evaluates final results of new product development and on-market projects to assure accomplishment of technical objectives.
Prepares and presents reports outlining the outcome of technical projects and makes recommendations for actions necessary to achieve desired results.
Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
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.
Drives and challenges the organization to achieve “state of the art” practices.
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.