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We Make Life More Rewarding and Dignified

Location : Ballina
Department : Quality

The Manager, Design Assurance (DA) supports the execution and continuous improvement of the Design Control & Risk Management processes. This role ensures that product designs meet intended requirements and comply with global regulatory standards by providing oversight and guidance to teams throughout the product development lifecycle. The Manager partners cross-functionally to implement robust design controls, support new product introductions (NPI), and drive quality excellence. This role also supports sustaining engineering activities and fosters a diverse and inclusive team environment.

Responsibilities:
• Support the Director of Design Assurance in establishing and maintaining global policies, procedures, and principles for design control, risk management and validation.
• Ensure the DA team consistently plans, executes and documents the appropriate application of the established procedures, processes and principles of design controls, risk management, usability and validation.
• Lead and mentor a team of DA engineers, focusing on resource allocation, training and professional development to build a high-performing team that employs critical thinking to foster a culture of quality.
• Manage resources to support product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes.
• Define clear roles and responsibilities to the cross functional team (R&D, RA, PM, Operations, Clinical) to ensure effective execution of the design controls process in New Product Introduction and change control.
• Work in a global and matrix environment leveraging strong leadership skills to influence change cross-functionally.
• Communicate critical design quality issues to Director, Design Assurance and senior leadership in a timely and effective manner.
• Work closely with the R&D, Marketing and Global Engineering teams to ensure robust new product launch planning and successful design transfer process.
• Serve as a subject matter expert in design controls, driving continuous improvement initiatives and leveraging tools for automation and real-time data insights.
• Support internal and external audits, including preparation and response related to design controls and product documentation.
• Assist Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission.
• Collaborate with R&D in the development and validation of test methods ensuring Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately.
• Work with R&D Usability Manger to support the development and appropriate application of the usability engineering process.
• Partner with Global Validation Manager to ensure appropriate process qualification is planned and critical to quality elements are transferred from design to the production processes.
• Collaborate with Supplier Quality to ensure component quality and support supplier quality initiatives.
• Assist in planning and executing design transfer activities and post-launch reviews to ensure product performance meets expectations.
• Support the monitoring of post-market surveillance data and contribute to feedback loops that inform design improvements and ensure any potential design issues are addressed.

• Other duties as assigned

Essential Functions of the Role:
• Work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
• Strong understanding of medical device design and development processes in a fast-paced R&D environment.
• Ability to interpret and apply regulatory standards (21 CFR 820, ISO 13485, ISO 14971, IEC 62366-1).
• Strong Leadership capability and ability to influence change balancing compliance with pragmatic solutions.
• Ability to manage multiple priorities in a dynamic environment.
• Consistent track record in delivering Continuous Improvement programs.
• Strong technical acumen and effective communication skills.
• Excellent written and verbal interpersonal skills to influence diverse stakeholders.
• Ability to present complex technical information to Senior Management.
• Experience working across cultures and time zones.
• Hands-on experience with design verification & validation (V&V), risk management, and usability engineering.

Work Experience Requirements:
• 8–12 years of experience in Quality Assurance, R&D, or related technical roles in a regulated industry.
• Minimum 2 years’ experience in a QA/R&D or other technical leadership role in a regulated environment.
• Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainty.
• Experience managing shifting priorities and making risk-based decisions under uncertainty.
• Experience working with remote teams preferred.

Education Requirements
• Bachelor’s Degree – Engineering/Science/Life Sciences or another related technical field. Advanced degree preferred.

Specialized Skills/Technical Knowledge:
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971 standards and EU MDR regulation
• Experience with advanced quality methodologies (FMEA, DOE, APQP).
• Familiarity with usability engineering and design for X (DFX).
• Goal-oriented with the ability to execute on strategic initiatives and prioritize/manage deliverables
• Good project management skills including organization and planning.
• Strong critical thinking skills applying and cultivating new approaches to problem solving with a focus on achievement of overall project goals
• Ability to work independently and remotely with minimum direct supervision.
• Greenbelt certification preferred with knowledge of Lean and Six Sigma methodology
• Knowledge of SAP ERP systems preferred.
• Proficiency in statistical tools (e.g. Minitab).
• Strong in Microsoft Office suite, especially Excel.

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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Manager Design Assurance