Senior Mechanical Engineer, Medical Devices & Mold

LKC Technologies, Inc.; Indiana; In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

LKC Technologies, Inc. is seeking an experienced Senior Mechanical Engineer to join a collaborative R&D team focused on innovative medical devices. This onsite role in Germantown, MD involves design, validation, and transfer through production.

You will work with cross-functional partners, mold design, and documentation to meet quality and regulatory requirements, supporting patient care through robust engineering.

Competenze

• 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.
• Experience developing and supporting injection-m 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.

Mansioni

• 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.

Conoscenze

Injection molding

Mold design

Cross-functional collaboration

Problem solving

Regulatory compliance

3D modeling (SolidWorks)

Prototyping and testing

Electrical/mechanical integration

Documentation

Formazione

Bachelor’s degree in Mechanical Engineering

Strumenti

SolidWorks

Descrizione del lavoro

LKC Technologies, Inc. is seeking an experienced Senior Mechanical Engineer to join a collaborative R&D team focused on innovative medical devices. This onsite role in Germantown, MD involves design, validation, and transfer through production.

You will work with cross-functional partners, mold design, and documentation to meet quality and regulatory requirements, supporting patient care through robust engineering.