Mechanical Engineer; Remote

Mechanical Engineer (Remote)

Job Description

This remote Mechanical Engineer role focuses on sustaining engineering for a medical device portfolio, with a strong emphasis on cost savings, product transfers, and design changes. You will ensure that existing products remain compliant, manufacturable, and cost-effective while maintaining high standards of quality and performance. The position offers the opportunity to collaborate with global, cross-functional teams and contribute directly to the reliability and continuous improvement of life-enhancing medical technologies.

Responsibilities

* Identify and implement cost reduction opportunities through material changes, process improvements, and supplier optimization while maintaining product quality and compliance.

* Collaborate closely with cross-functional teams, including Quality, Manufacturing, and Supply Chain, to evaluate, validate, and implement cost-saving proposals.

* Conduct root cause analyses and risk assessments to ensure that changes preserve product integrity, safety, and regulatory compliance.

* Lead or support the transfer of products between manufacturing sites or suppliers, ensuring continuity of supply and consistent product quality.

* Develop, maintain, and update engineering documentation such as drawings, specifications, and validation protocols to reflect current designs and processes.

* Coordinate with global teams to plan and execute product transfers, minimizing disruption to supply and ensuring a smooth transition.

* Evaluate and implement design changes that improve product performance, manufacturability, and regulatory compliance.

* Support formal change control processes, including design verification, design validation, and the timely update of documentation.

* Work closely with R&D, Regulatory, and Quality teams to ensure design changes align with applicable standards, regulations, and internal procedures.

* Apply principles of design input, design output, design verification, and design validation (DIOVV) throughout sustaining engineering activities.

* Use Solid Works and other engineering tools to create, modify, and review mechanical designs and related documentation.

* Manage multiple sustaining engineering projects concurrently, ensuring tasks are completed on time and in alignment with project goals.

Essential Skills

* Bachelor's degree in Mechanical Engineering or a related field.

* At least 3 years of experience in mechanical engineering, preferably within the medical device or other regulated industry.

* Strong understanding of mechanical design principles, mechanical systems, and materials.

* Proficiency in Solid Works for 3D modeling and mechanical design.

* Experience with sustaining engineering activities for existing products.

* Knowledge of design for manufacturability and the ability to optimize designs for production.

* Experience with engineering documentation systems, including the creation and maintenance of drawings, specifications, and protocols.

* Familiarity with FDA regulations and other relevant medical device standards and guidelines.

* Strong understanding of design input, design output, design verification, and design validation (DIOVV) processes.

* Demonstrated problem-solving skills with the ability to perform root cause analysis and risk assessment.

* Effective communication skills for collaborating with cross-functional and global teams.

* Solid project management abilities, including organizing tasks, managing timelines, and coordinating stakeholders.

Additional

Skills & Qualifications

* Experience with product lifecycle management (PLM) systems.

* Knowledge of validation and verification processes for medical devices or other regulated products.

* Experience working in cross-functional, global team environments.

* Experience in medical device sustaining engineering or similar regulated product support.

* Ability to document and present technical information clearly and accurately.

* Strong attention to detail and commitment to maintaining high quality standards.

Work Environment

This is a fully remote position, providing flexibility in work location while requiring reliable connectivity and effective virtual…