Sr. Mechanical Engineer
AMETEK · Germantown
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:
Medical Device Development
- 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.
- Work closely with cross-functional team members to ensure successful execution of product development milestones.
Manufacturing Cell Development
- 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, and test methods.
- Identify and implement design modifications required to improve manufacturability, reliability, throughput, and product quality.
- Collaborate with manufacturing, quality, and operations personnel to transition development activities into production.
Injection Mold Development & Validation
- Lead the development and qualification of new injection molds and molded components.
- Serve as the primary technical liaison with mold makers, injection molding vendors, and component suppliers.
- Coordinate mold design reviews, tooling acceptance, and first article inspections.
- Work with the Quality team to develop and ensure the execution mold validations.
- Troubleshoot molding and dimensional issues and drive corrective actions with suppliers.
Design Controls & Documentation
- Generate and maintain comprehensive medical device design documentation in compliance with applicable quality and regulatory requirements.
- Prepare and update:
- Design input and output documentation
- Engineering drawings and specifications
- Design verification and validation documentation
- Risk management files
- Test protocols and reports
- Change orders and engineering change documentation
- Design input and output documentation
- Participate in design reviews and ensure compliance with established design control processes.
Supplier & Partner Management
- Identify, select, and manage external development and manufacturing partners.
- Coordinate activities with:
- Industrial design firms
- Injection molders
- Tooling suppliers
- Electrode manufacturers
- Industrial design firms
- Monitor supplier performance and ensure technical deliverables meet 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.