Quality Engineer- Medical Device

ABOUT WARWICK CONSULTING

Warwick Consulting provides comprehensive engineering services to the medical device industry, specializing in non-compliance remediation, software assurance, cybersecurity, and human factors engineering. Our work also spans software as a medical device (SaMD), verification and validation (V&V), and research and development (R&D) support.

Since 2011, we’ve supported clients in over 25 therapeutic areas and facilitated the commercialization of more than 35 medical devices.

Position Summary

We are seeking a motivated Quality Engineer (Entry to Early Career) to support quality engineering activities across medical device development programs, including electro-mechanical and software-based products. This role will contribute to new product development (NPD) and design changes, helping ensure that product quality is incorporated into the design process and that deliverables align with regulatory and internal quality system requirements.

Key Responsibilities

·      Support quality engineering activities on new product development teams for medical devices, including electro-mechanical systems and Software as a Medical Device (SaMD).

·      Assist in the review of design inputs, verification protocols, validation reports, and design transfer documentation under guidance from senior quality engineers.

·      Participate in design change assessments, including documentation updates, risk evaluations, and coordination of verification activities.

·      Help ensure compliance with applicable regulations and standards (e.g., 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304).

·      Support risk management activities, including contributing to FMEAs, hazard analyses, and risk documentation.

·      Collaborate with cross-functional teams such as R&D, Regulatory, and Systems Engineering to support quality integration into product development.

·      Assist in maintaining Design History Files (DHF) and ensuring proper documentation and traceability.

·      Contribute to internal quality system improvements and continuous improvement initiatives.

Qualifications

·      Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Software Engineering, or a related technical field.

·      0–3 years of experience in the medical device or regulated industry (internships/co-ops applicable).

·      Basic understanding of design control requirements and product development lifecycle concepts.

·      Exposure to electro-mechanical systems, embedded systems, or regulated software is a plus.

·      Familiarity with quality and regulatory standards such as ISO 13485, ISO 14971, or 21 CFR Part 820 is preferred.

·      Strong attention to detail, analytical thinking, and willingness to learn.

·      Good communication and documentation skills, with the ability to work in a team environment.

COMPENSATION

·      Commensurate with experience

·      40 hours/week, 6-month W-2 contract

·      Potential conversion to full-time employee based on performance and business needs