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:

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

• 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

• 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.

Compensation

Employee Type: Salaried

Currency: USD

Salary Minimum: 115,000

Salary Maximum: 150,000

Incentive: No

Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.

For more information on AMETEK's competitive benefits, please click here.

AMETEK, Inc. is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales over $7.5 billion.

AMETEK is committed to making a safer, sustainable, and more productive world a reality. We use differentiated technology solutions to solve our customers' most complex challenges. We employ 22,000 colleagues, in 35 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK is a component of the S&P 500. Visit https://www.ametek.com/careers for more information.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1 (866) 263-8359.

Nearest Major Market: Washington DC