Job 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 preferred).
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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