Job Description
The R&D Assembly Technician performs product development and prototype assembly activities on medical devices within the Development department in support of departmental objectives to provide goods and services that meet customer requirements for quality, quantity, and timeliness.
The primary responsibility of this position is to work directly with Project Engineers to build pilot production quantities of new products by following written and demonstrated procedures and conducting testing of products and components. A wide variety of assembly techniques, tools, equipment, and manufacturing processes are utilized to create medical device products and sub-assemblies in a laboratory and manufacturing environment.
Essential Duties and Responsibilities - Follow the Aptyx Quality System, including all applicable SOPs and work instructions identified within the Training Matrix.
- Assemble small and complex medical device components and sub-assemblies according to written and verbal procedures.
- Work independently with minimal supervision while completing assignments accurately and within required timelines.
- Maintain confidentiality of proprietary and customer information in accordance with Company policy.
- Adhere to all company safety policies, procedures, and laboratory/manufacturing safety requirements.
- Operate equipment and tools used in catheter and medical device assembly, including adhesive dispensers, vertical shrinkers, braiders, tipping machines, drilling equipment, punching devices, and measurement tools.
- Maintain accurate written records of materials used, procedures followed, and inspection results using supplied documentation forms and records (e.g., LHRs and associated documentation).
- Support troubleshooting activities by identifying equipment issues and communicating repair or upgrade needs to appropriate personnel.
- Maintain effective working relationships and collaborate professionally with engineers, technicians, and manufacturing personnel.
- Track materials, tools, and process steps throughout the assembly process to ensure traceability and compliance with requirements.
- Verify incoming materials meet purchase order and specification requirements.
- Assist Project Engineers with modifications to written procedures and provide recommendations for process, assembly, or product improvements.
- Perform testing of devices and components in accordance with approved protocols, procedures, and engineering instructions.
- Support prototype builds, pilot manufacturing activities, and engineering development projects as required.
- Assist with maintaining organized laboratory and work areas to support efficient operations and compliance requirements.
- Perform additional duties as assigned.
Qualifications - Ability to read, write, speak, and understand English.
- Ability to follow detailed written and verbal instructions.
- Ability to work effectively in a team-oriented, fast-paced development environment.
Education - Associate degree in a scientific, technical, or engineering-related field preferred; equivalent combination of education and experience may be considered.
Experience - 0-3 years of related experience required.
- Medical device manufacturing or assembly experience preferred.
- Experience working in a regulated environment preferred.
Skills, Knowledge, and Abilities - Technical aptitude with experience in plastic component assembly, adhesive bonding, prototyping, or related manufacturing processes preferred.
- Strong attention to detail and commitment to workmanship quality.
- Ability to read and interpret engineering drawings, specifications, and assembly procedures.
- Ability to understand measurement units and accurately perform measurements using inspection tools and devices.
- Manual dexterity and ability to work with very small components and assemblies.
- Basic problem-solving and troubleshooting skills.
- Ability to prioritize tasks and support multiple projects simultaneously.
- Effective communication and collaboration skills.
Acknowledgement I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.
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Full time