Design Quality Engineer

S4 Analytics LLC; Massachusetts; On-site; USD 90,000 - 140,000; Full time

Job summary

S4 Analytics LLC is seeking a Design Quality Engineer to support new product development in its orthopedic device portfolio. This role partners with R&D, manufacturing, suppliers, and regulatory teams to ensure design controls, risk management, and design transfer are integrated from concept through commercialization.

The ideal candidate has hands-on experience with orthopedic devices or metal implants, strong knowledge of FDA QSR, ISO 13485, EU MDR, and IQ/OQ/PQ validation.

Qualifications

• Medical Device NPD experience required.
• Experience with orthopedic devices/metal implants.
• IQ/OQ/PQ experience required.
• Strong Design Controls & ISO 14971 knowledge.
• Engineering background preferred.

Responsibilities

• Support Quality activities for New Product Development (NPD).
• Manage Design Controls, Design Verification/Validation, and Design Transfer.
• Work with suppliers on IQ/OQ/PQ process validation.
• Review DHF and support design reviews.
• Ensure compliance with FDA QSR, ISO 13485, and EU MDR.
• Support CAPA, root cause analysis, Cpk/Ppk, and DFM activities.

Skills

NPD experience

Orthopedic devices

Design Controls

ISO 14971

Tools

IQ/OQ/PQ

Job description

S4 Analytics is a growing consulting and workforce solutions firm headquartered in Texas and New Jersey, specializing in connecting highly skilled professionals with leading organizations across the Life Sciences, Semiconductor, Automotive, Defense, Data Center, and IT industries. We are committed to building long-term partnerships by delivering top talent and customized staffing solutions that support our clients’ evolving business and project needs.

Overview

We're seeking a Design Quality Engineer to support new product development (NPD) initiatives within our clients orthopedic device portfolio. This role partners closely with R&D, manufacturing, suppliers, and regulatory teams to ensure quality is built into the design process from concept through commercialization. The ideal candidate brings hands‑on experience with orthopedic and/or metal implant devices and a strong command of design controls, risk management, and supplier process validation.

Responsibilities:

• Support Quality activities for New Product Development (NPD).
• Manage Design Controls, Design Verification/Validation, and Design Transfer.
• Work with suppliers on IQ/OQ/PQ process validation.
• Review DHF and support design reviews.
• Ensure compliance with FDA QSR, ISO 13485, and EU MDR.
• Support CAPA, root cause analysis, Cpk/Ppk, and DFM activities.

Must Have:

• Medical Device NPD experience – Required.
• Experience with orthopedic devices/metal implants.
• Supplier-facing IQ/OQ/PQ experience – Required.
• Strong Design Controls & ISO 14971 knowledge.
• Engineering background preferred.

Screening Questions:

• NPD Quality experience?
• Mechanical, Manufacturing, or Process Engineering background?