Senior Mechanical Engineer, Med Device Mold & Validation

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

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.