Manufacturing Engineer I (Medical Device)

Job DescriptionJob Description Position Summary As a Manufacturing Engineer I at Aptyx, you will contribute to the development and production of interventional and transcatheter medical devices, including implants, catheters, and other disposable products. This entry-level engineering role supports Aptyx's commitment to delivering end-to-end solutions, engineering excellence, and innovation in Class II and III medical devices. You will work hands-on in process development, equipment setup, validation, and continuous improvement initiatives, while collaborating with cross-functional teams and external suppliers. Duties and Responsibilities Responsible for following the Aptyx Quality System, including all applicable SOPs included in the Training Matrix. Hands-on process development of catheters, implants and other medical devices. Assist in the setup of pilot and manufacturing equipment and procedures for devices. Setup and support installation qualification (IQ) of new equipment. Contribute to production builds by maintaining documentation, delivering training with guidance, and supporting line setup and troubleshooting. Assist in design changes to existing product lines as necessary. Contribute to DFM reviews by identifying common manufacturing risks and suggesting improvements to R&D teams. Coordinate with suppliers to support material specification updates and assist in validation and quality-related discussions. Contribute to the execution and documentation of validation activities, including IQ, OQ, PQ, TMV, Gage R&R, and MSA, with guidance from more senior engineers. Contribute to the investigation and documentation of customer complaints, CAPAs, and NCRs with guidance from senior engineers. Contribute to document reviews (e.g., work instructions, routings, BOMs) by assessing changes for potential impacts on specific process steps or outputs. Contribute to the creation and maintenance of pFMEAs by identifying potential failure modes and supporting risk assessments. Assist in maintaining master validation plans and contribute to identifying validation needs based on predefined risk criteria. Contribute to Lean and Six Sigma initiatives by identifying minor inefficiencies and supporting improvement projects. Maintain and update ERP records including BOMs, routings, and change orders with guidance. Contribute to COGS analysis by monitoring cost trends and suggesting simple cost-saving ideas. Contribute to process analysis by performing time studies and suggesting basic improvements to reduce inefficiencies. Contribute to capacity planning by analyzing basic production data and proposing minor layout adjustments to improve flow. Communicate project status and basic technical updates to customers, escalating issues and aligning deliverables with support from the team. Review your own work and the work of technicians; request the review of Senior or Principal Engineers. Contribute to crafting design specifications and standards in collaboration with the engineering team. Qualifications Bachelor's degree in engineering or related technical field required. 1+ years of relevant experience in a manufacturing or product development environment (medical device industry ). Skills, Knowledge, and Abilities Proficiency in SolidWorks or similar CAD software. Basic understanding of process validation (IQ, OQ, PQ), test method validation, and risk management tools (pFMEA, MSA). Familiarity with ERP systems and documentation control. Strong communication and collaboration skills. Ability to perform time studies and basic data analysis. Exposure to Lean and Six Sigma methodologies is a plus. Detail-oriented with a commitment to quality and continuous improvement. Measurement of Performance Adherence to Aptyx Quality System and SOPs. Timely and accurate completion of assigned validation and documentation tasks. Effective communication with internal teams and external customers. Contribution to process improvements and cost-saving initiatives. Demonstrated growth in technical skills and project ownership.

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