Sr Manager, NPI Quality Engineering

Job Summary

The Sr. Manager, New Product Quality leads and develops a team of New Product Quality Engineers responsible for ensuring the quality and regulatory compliance of medical device products from early-stage design through commercial launch and launch stability. This role is accountable for establishing and maintaining robust quality system processes that support new product introduction (NPI), preservation of design intent, and readiness for regulatory submissions and audits.

The role operates at the intersection of R&D, Regulatory Affairs, and Manufacturing, driving quality planning, design assurance activities, and risk management execution across the full product development lifecycle - including post-launch monitoring and stability validation through commercial steady state.

Duties & Responsibilities

* Lead quality planning activities across the product development lifecycle, including development of Quality Plans, Design History Files (DHFs), and risk management documentation in accordance with ISO 14971

* Drive design assurance activities including design reviews, verification and validation planning and execution, and ensuring traceability from user needs through design outputs

* Own quality inputs to regulatory submissions (510(k), De Novo, PMA as applicable), ensuring completeness, accuracy, and alignment with applicable standards and FDA/international requirements

* Oversee design transfer activities, ensuring manufacturing processes, specifications, and validations are established and documented prior to commercial launch

* Ensure manufacturing processes introduced through NPI are executed in accordance with approved procedures, specifications, and process validations (IQ/OQ/PQ)

* Lead post-launch stability monitoring activities, including coordinating surveillance data review, complaint trending, and corrective action as needed through commercial steady state

* Own and oversee quality input to design and process changes during development and the launch stability period (ECOs, deviations, waivers), ensuring thorough impact assessments determine verification, validation, and documentation requirements

* Ensure design intent and essential performance are preserved across design iterations, supplier selections, and manufacturing scale-up

* Oversee evaluation of design and process decisions for impact to patient, user, and operator safety; ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented

* Ensure compliance with applicable regulations and standards throughout the product development lifecycle, including ISO 13485, FDA 21 CFR 820/QMSR, EU MDR (as applicable), IEC 60601-1, and IEC 62304 (as applicable)

* Collaborate with Regulatory Affairs, R&D, Clinical, Manufacturing Engineering, Operations, and Supply Chain to ensure seamless NPI execution and on-time launch readiness

* Partner with Supplier Quality on supplier qualification and selection activities supporting new products, including quality agreements, incoming inspection strategy, and supplier change evaluation

* Provide escalation support for significant quality issues arising during development or the launch stability period that impact product safety, regulatory compliance, or program timelines

* Lead, mentor, and develop a team of New Product Quality Engineers; set clear priorities, goals, and performance expectations aligned with program milestones and quality objectives

* Ensure appropriate staffing, training, and competency development to support a growing NPI portfolio

Minimum &

Preferred Qualifications and

Experience:

Minimum Qualifications

* Direct experience leading quality or engineering functions supporting new product development and commercial launch of regulated medical devices

* Strong working knowledge of design controls, risk management (ISO 14971), verification and validation planning, and design transfer requirements

* Demonstrated experience with regulatory submissions (510(k), PMA, or equivalent) and familiarity with FDA and international regulatory expectations for product development documentation

* Solid understanding of CAPA, nonconformance management, change control, and root cause analysis methodologies as applied in a development and launch stability context

* Excellent verbal and written communication skills, with the ability to clearly convey complex quality and regulatory concepts to cross-functional stakeholders and executive leadership

* Strong organizational and prioritization skills with the ability to manage multiple concurrent programs and competing deadlines

* Excellent documentation practices, including attention to detail, record maintenance and traceability, and understanding of DHF/DMR structure and document control requirements

Preferred Qualifications

* Experience in patient monitor systems, hospital-based products, software or electronic device products;

* Experience with FDA/GMP requirements for medical device;

* Strong working knowledge of ISO…