Design Software Quality Consultant (Medical Devices)

Stark Pharma Solutions Inc

Piscataway, NJ, United States

2 months ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

10 years minimum

Compensation

$59,150.0 - $106,925.0

Working hours

Regular working hours

Job source

www.careerjet.com

Tech stack

Computer-Aided Design Software Quality Software Licensing Audit Software Engineering Software Verification

Job description

We are seeking an experienced Design Software Quality Consultant to support post-acquisition integration activities for a medical device product portfolio. This role will focus on ensuring software design quality, regulatory compliance, and successful integration of acquired products into the client’s quality management system. The ideal candidate will have deep expertise in Software Design Quality, Model-Based Systems Engineering (MBSE), and medical device software compliance, with experience supporting new product development in regulated environments., * Review and assess Design History Files (DHFs) and product development documentation for acquired medical device products.

Support software design quality activities during post-acquisition product integration.
Ensure compliance with internal quality standards and global regulatory requirements.
Lead Model-Based Systems Engineering (MBSE) activities for software-enabled medical devices.
Review software engineering deliverables to ensure compliance with design controls and quality requirements.
Partner with cross-functional teams including R&D, Software Engineering, Quality, and Regulatory Affairs.
Support risk management, usability engineering, and software lifecycle compliance activities.

Requirements

10+ years of Software Quality Engineering experience in the medical device industry.
Strong experience with Software Design Quality and Design Controls.
Hands-on experience with Model-Based Systems Engineering (MBSE).
Experience supporting software quality for new product development or medical device integration/remediation projects.
Knowledge of IEC 62304, IEC 60601, ISO 14971, and medical device software regulations.
Experience with Software as a Medical Device (SaMD).
Strong understanding of software verification, validation, and compliance within regulated environments.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you. Please follow Stark Pharma Solutions on LinkedIn for the latest job updates