Senior Manager, Design Quality

The Senior Manager Design Quality is accountable for both the execution and governance of design quality and development excellence across the product lifecycle from user needs and design inputs through design transfer and ongoing postmarket performance. This role ensures that design intent risk controls usability requirements and verification and validation (V&V) strategies are appropriately defined rigorously executed by programs and sustained to enable highquality compliant product launches. This role integrates postmarket feedback field performance data and reliability insights into design quality strategies to drive continuous product improvement risk reduction and prevention of recurrence.

As a people manager the Senior Manager Design Quality leads and develops a team of design quality engineers and partners closely with R&D Clinical Regulatory Product Management and other Product Quality functions to ensure products are safe effective reliable and inspectionready throughout their lifecycle.

Key Responsibilities

• Defines and executes an endtoend product lifecycle design quality strategy ensuring alignment from development through commercialization and ongoing postmarket performance
• Accountable for assuring endtoend design control activities are effectively executed by programs including traceability from user needs through verification and validation
• Responsible for design risk management and assurance that usability engineering activities are appropriately applied and effective in accordance with applicable standards (e.g. ISO 14971 IEC 62366)
• Ensures Design History Files (DHF) demonstrate completeness accuracy and readiness to support highquality product launches and inspections
• Accountable for assuring the effectiveness and adequacy of design verification and validation (V&V) activities by reviewing and approving strategies protocols and reports
• Confirms statistical rationale sample sizes and coverage of design and user requirements are appropriate to demonstrate product performance and intended use
• Assures objective evidence is sufficient to verify all design risk controls and support a highquality compliant product launch
• Provides oversight and challenge to program teams to ensure V&V findings design evaluations root cause analyses and regression testing results are appropriately addressed
• Owns and drives product quality improvement projects to address postmarket feedback field issues and emerging risk signals
• Partners with Customer Quality Manufacturing Quality Supplier Quality and R&D to translate field data complaints and reliability insights into prioritized design improvements
• Leads root cause analysis and crossfunctional countermeasure implementation to prevent recurrence and improve product performance across the lifecycle
• Partners with Regulatory and Clinical teams to support regulatory submissions and inspections
• Provides subjectmatter expertise for design controls V&V and risk management during audits
• Partners closely with R&D Clinical Regulatory Product Manufacturing Quality and Supplier Quality teams to enable compliant ontime product launches
• Promotes advanced quality engineering practices and a culture of quality excellence and continuous improvement
• Directly leads coaches and develops a team of design quality engineering professionals
• Sets clear performance expectations provides regular feedback and supports technical skill development
• Fosters a culture of accountability technical rigor and continuous improvement

Education and Experience

• Bachelors in Engineering Science or related field; advanced degree (MS MBA) preferred.
• 12 years in medical device quality/engineering across the product lifecycle (design controls supplier quality manufacturing quality customer quality) with 7 years managing people and managers.
• Direct experience preparing for/hosting FDA Notified Body and other health authority inspections; strong understanding of regulatory submissions and technical documentation expectations.
• Equivalent combination of education and experience will be considered.

Competencies

• Global device QMS & regulations: expert knowledge of ISO 13485; ISO 14971 risk management; ISO/TR 20416 post market surveillance; IEC 623661 usability engineering; and regional regulations including FDA 21 CFR Part 820 (QMSR) 21 CFR 803/806 and EU MDR 2017/745.
• Demonstrated ability to connect design requirements and risk controls to V&V plans supplier requirements/capabilities manufacturing controls and post market performancewith strong requirement traceability discipline.
• Advanced competency in statistics for quality: sampling plans process capability (Cp/Cpk Pp/Ppk) SPC reliability methods and trend/signal detection.
• Deep experience with design controls risk files DHF/DMR/Technical Documentation process validation (IQ/OQ/PQ) and change control across internal and external manufacturing.
• Business acumen and executive communication; able to translate complex quality/risk topics into clear recommendations and influence across R&D Operations Clinical and Regulatory functions.
• Technology fluency with eQMS PLM and requirements management tools
• Advanced leadership skills to prioritize team capability building optimize staffing investments and inspire teams in alignment with business priorities.
• Consistently gathers voice of customer at gemba to ensure customer problems are prioritized and solved.
• Challenges the status quo and coaches others to take a stand in support of the organizations purpose.
• Fosters a culture of experimentation and challenges others to develop breakthrough solutions.
• Models collaboration and ensures crossfunctional prioritization to support organizational vision and strategy.
• Demonstrates urgency and ownership to consistently deliver on objectives using FBS.

Working Conditions

• Travel up to 2530% domestic and international.
• Work may occur in office lab manufacturing and supplier environments; ability to use appropriate PPE and comply with sitespecific EHS requirements.
• Typical office activities include extended periods of sitting/standing keyboard use and frequent communication.
• Lifting up to 25 lbs occasionally; occasional walking/standing on manufacturing floors.
• Schedule may periodically require coverage across global time zones.