Electro-Mechanical Technician

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* Position Summary:

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* The Electro-Mechanical Engineer will support the development, testing, validation, and commercialization of medical device components, assemblies, and equipment. This role is hands-on and highly collaborative, working closely with Engineering, R&D, Operations, and external suppliers to ensure new products and processes meet performance, quality, and regulatory requirements.

This individual will play a critical role across the full product lifecycle-from prototyping and early development through validation, equipment runoff, and transition to manufacturing-while maintaining detailed documentation and supporting knowledge transfer within the organization.

** Job Responsibilities/ Requirements:*
* ** Testing & Validation Support*
* + Perform acceptance testing on product prototypes and new products throughout the development lifecycle.

+ Prepare, set up, execute, and tear down test configurations for components, subassemblies, and equipment.

+ Operate both third-party test equipment and Ethicon devices/systems.

+ Conduct validation testing, equipment runoff, and acceptance testing for new equipment.

+ Document test results clearly and communicate findings to the engineering team, including preparation of detailed reports and first-level data analysis.

+ Assist in the development and refinement of test procedures and protocols, recommending improvements based on available equipment and technical constraints.

+ Maintain written test procedures, best practices, and documentation to support training and long-term knowledge retention.

+ Provide training and onboarding support for new testing personnel as needed.

+ Apply basic engineering and statistical techniques, including process capability studies, validation protocols, and process validation activities.

+ Develop solutions that meet defined quality, performance, and cost targets.

** Prototyping & Process Development*
* + Build, maintain, and operate prototype, test, and production equipment.

+ Support the installation, startup, debugging, and validation of new products and equipment.

+ Manage hands-on aspects of early-stage development and engineering builds.

+ Interface with equipment suppliers to ensure systems and components meet defined performance specifications.

+ Collaborate with operations teams to ensure smooth transition of equipment and processes from prototype to production.

+ Perform incoming equipment and component testing to meet internal quality requirements.

+ Assist in creating, maintaining, and updating standard operating procedures (SOPs).

+ Provide equipment and process training to both R&D and operations personnel.

+ Support component qualification documentation and technical packets.

+ Organize and conduct engineering builds.

+ Support process development and qualification strategies for:

+ Components and component tooling

+ Assembly processes and equipment

+ Tools and gauges

+ Software-driven systems

** Logistics & Documentation Support*
* + Track equipment and component inventory throughout the product lifecycle.

+ Manage equipment and component flow through the purchasing process to ensure on-time delivery.

+ Interface with internal procurement teams and external suppliers.

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* Qualifications:

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* ** Required*
* + 3-5 years of experience in a regulated industry (medical device, pharmaceutical, aerospace, automotive, or similar).

+ Hands-on experience with testing, prototyping, validation, or manufacturing support.

+ Ability to read and understand technical instructions, drawings, and specifications.

+ Strong documentation and communication skills.

+ Experience working with test equipment, mechanical systems, and electro-mechanical assemblies.

+ Comfort working in a lab, prototype, or production-adjacent environment.

+ Basic understanding of statistical methods and validation principles.

** Preferred*
* + Associate's degree (2-year) in Engineering Technology, Electro-Mechanical Technology, Mechatronics, or related technical field.

+ Experience supporting FDA-regulated or ISO-compliant environments.

+ Familiarity with process validation, equipment qualification, and component qualification processes.

+ Experience transitioning products from…