Project Engineer - Medical Devices

Project Engineer – Cleveland, Ohio

The Project Engineer role, based in Cleveland, Ohio, involves leading and supporting biomaterials-focused medical device manufacturing and product development efforts. This engineer plays a hands-on role in advancing projects across advanced wound care, dental, and orthopedic applications, working closely with production technicians, maintenance and manufacturing engineers, and quality engineers within a regulated environment.

The engineer is responsible for driving projects from early concept through manufacturing, ensuring technical rigor, strong documentation practices, and compliance with ISO 13485 and related quality standards. This position is fully on-site and requires daily interaction on the production floor to troubleshoot issues, optimize processes, and translate customer and internal requirements into practical, scalable solutions.

The role supports both fee-for-service design and development activities and internal product lines, often balancing multiple projects as the organization scales. Ideal candidates bring a strong engineering foundation, particularly in materials, chemical, biomedical, or mechanical engineering, paired with disciplined documentation habits and the ability to work effectively in a small, fast-paced, engineering-focused environment.

The Challenge Ahead

The Project Engineer contributes to the development and scaling of biomaterials-based medical device products across advanced wound care, dental, and orthopedic markets. This individual leads and supports projects from concept through manufacturing, working directly on the production floor, developing robust processes, and ensuring that all work meets regulated quality requirements, including ISO 13485 oversight.

Success in this role requires technical depth, strong communication skills, and the ability to coordinate effectively with manufacturing, quality, operations, leadership, and external partners. Experience in medical devices, biomaterials, or regulated manufacturing is highly advantageous. Strong documentation skills are essential for supporting regulatory, quality, and cross-functional needs.

This position requires working fully on-site, Monday through Friday, to support hands-on engineering and manufacturing operations.

Key Responsibilities

Biomaterials and polymer processing equipment, laboratory and manufacturing instrumentation, CAD and basic modeling tools, and standard medical-device quality and documentation systems.

• Writing clear and concise technical documentation and protocols suitable for execution and audit in a regulated environment
• Solving manufacturing and product development challenges using sound engineering principles and consistently delivering stable and repeatable solutions
• Participating in design, process, and documentation reviews to share knowledge and support cross-functional collaboration
• Supporting a strong culture of quality and regulatory compliance
• Assisting in project planning with realistic technical milestones, timelines, and deliverables
• Communicating effectively within engineering teams and with manufacturing, quality, leadership, and other cross-functional areas
• Shifting between new process and product development and existing manufacturing support based on business priorities
• Collaborating with internal teams and external partners to define requirements and implement high-quality technical solutions
• Recommending tools and process improvements to enhance efficiency, quality, and scalability within a regulated manufacturing environment
• Contributing to the continuous improvement of engineering and quality processes under ISO 13485

Qualifications

• 5 to 10 or more years of engineering experience, ideally with project engineering responsibilities
• Experience working within a regulated medical device environment under ISO 13485
• Bachelor’s degree or higher in Biomedical, Chemical, Mechanical, Polymer Engineering, or a closely related field
• Strong background in materials, biomaterials, or chemical engineering, with hands-on experience supporting manufacturing operations
• Proven ability to manage engineering projects end to end, from requirements and design through validation and production transfer
• Strong technical documentation skills, including creation and maintenance of protocols, reports, and regulated technical files
• Effective communicator capable of working closely with technicians, cross-functional teams, and leadership in an on-site environment
• Experience in small to mid-sized, highly technical, or fast-paced organizations preferred
• Experience in advanced wound care, dental, or orthopedic products preferred