Sr. Mechanical Engineer

AMETEK, Inc.; Germantown (MD); On-site; USD 115,000 - 150,000; Full time

Job summary

AMETEK, Inc. is seeking an experienced Senior Mechanical Engineer to join a cross-functional R&D team focused on innovative medical devices.

This onsite role in Germantown, Maryland involves designing, validating, and transferring products from concepts through manufacturing. You will work with suppliers and manufacturing teams to develop injection-molded components, electromechanical systems, and device documentation that meet quality and regulatory requirements.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 8+ years of product development experience in the medical device industry.
• Experience with injection-m molded plastic components and tooling.
• Experience with mold qualification and validation activities (IQ, OQ, PQ).
• Strong understanding of medical device design controls and regulated development.
• SolidWorks proficiency for 3D modeling, assemblies and drawings.
• Experience developing test methods, fixtures and verification protocols.
• Hands-on prototyping, testing, troubleshooting and evaluation of prototypes.
• Experience 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 and attention to detail for quality and regulatory compliance.

Responsibilities

• Guide 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 to improve manufacturability, reliability, throughput and quality.
• Collaborate with manufacturing, quality and operations to transition development to production.
• Contribute to design and development of a medical device platform, including enclosure design and patient-contact 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.
• Maintain design documentation aligned with quality/regulatory requirements.
• Coordinate with external partners (industrial design firms, molders, suppliers, electrode manufacturers).
• Monitor supplier deliverables and align with project requirements.

Skills

Project management

Communication

Team collaboration

Problem-solving

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Job description

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Business Unit: Ophthalmic & Precision Solutions

Posting Date: Jul 27, 2026

Job Description: 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.

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.

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

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 22,000colleagues, in 35countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK isacomponent of the S&P 500. Visithttps://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 [phone].