Hologic, Inc. · 1 day ago
Manager, Design Assurance
Louisville, CO
Full-time
Onsite
Mid, Senior Level
$122K/yr - $200K/yr
8+ years expHologic empowers people to live healthier lives everywhere, every day. The 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.
BiotechnologyHealth CareHealth DiagnosticsWomen's
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
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
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
Qualification
Required
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
Preferred
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
Benefits
Bonus eligible
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
Company data provided by crunchbase