Sr. Mechanical Engineer

LKC Technologies is seeking an experienced Senior Mechanical Engineer to join a collaborative Research & Development team focused on innovative medical devices. In this onsite role in Germantown, Maryland, you will contribute to the design, validation, and commercialization of current and new products from concept through manufacturing transfer and production support.

You will work with cross-functional partners, external suppliers, and manufacturing teams to develop injection-molded components, electromechanical systems, and medical device documentation that meet applicable quality and regulatory requirements. This role is a strong fit if you enjoy hands-on engineering, practical problem solving, and developing products that support patient care.

Responsibilities:

• Guide the development and qualification of new injection molds and molded components.
• Serve as a technical partner to mold makers, injection molding vendors, and component suppliers.
• Coordinate mold design reviews, tooling acceptance activities, and first article inspections.
• Partner with Quality to develop and execute mold validation activities.
• Troubleshoot molding and dimensional issues and support corrective actions with suppliers.
• Support completion and deployment of a manufacturing cell for a medical device.
• Develop and execute equipment qualification, calibration, and process verification activities.
• Create manufacturing procedures, work instructions, test methods, and verification documentation.
• Identify and implement design modifications that improve manufacturability, reliability, throughput, and product quality.
• Collaborate with manufacturing, quality, and operations teams to transition development activities into production.
• Contribute to the design and development of a medical device platform, including enclosure design, cabling, and patient-contacting electrode systems.
• Generate mechanical designs, assemblies, prototypes, and detailed drawings.
• Participate in design reviews, risk assessments, design verification, and validation activities.
• Support design transfer and manufacturing implementation activities.
• Generate and maintain design documentation in alignment with applicable quality and regulatory requirements.
• Prepare and update design inputs and outputs, engineering drawings, specifications, verification and validation documentation, risk management files, test protocols, reports, change orders, and engineering change documentation.
• Coordinate activities with industrial design firms, injection molders, tooling suppliers, electrode manufacturers, and other external partners.
• Monitor supplier deliverables and support alignment with project requirements.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
• 8+ years of product development experience, including significant experience in the medical device industry.
• Demonstrated experience developing and supporting injection-molded plastic components and tooling.
• Experience with mold qualification and validation activities, including IQ, OQ, and PQ.
• Strong understanding of medical device design controls and regulated product development.
• Proficiency with SolidWorks for 3D modeling, assemblies, and detailed drawings.
• Experience developing test methods, fixtures, and verification protocols.
• Hands-on experience building, testing, troubleshooting, and evaluating prototypes.
• Experience working directly with external suppliers and manufacturing partners.
• Clear written and verbal communication skills.
• Ability to manage multiple priorities in a collaborative R&D environment.
• Problem-solving skills and attention to detail in support of quality and regulatory compliance.

Preferred Qualifications:

• Experience with skin-contact electrodes, wearable devices, biosensors, or patient-contact medical products.
• Knowledge of ISO 13485, FDA Quality System Regulations, and medical device development processes.
• Experience supporting manufacturing automation, assembly cells, or production equipment qualification.
• Familiarity with cable design, electromechanical systems, and medical device connectivity solutions.
• Experience facilitating technical discussions with suppliers, consultants, and cross-functional stakeholders.