As the Associate Production Engineer, you will be the technical lead for the assembly and delivery of our precision robotic prostate biopsy systems. As part of the link between R&D, the manufacturing line, and the clinic, you will play a pivotal role in ensuring that every unit is built to exact specifications.
You will also be expected to manage the production workflow, help troubleshoot electromechanical issues, and drive Design for Manufacturing (DFM) initiatives to prepare our platform for the next horizon of ablation therapy.
We are looking for a high-potential engineer with a trajectory toward Production Manager. Candidate seniority (Associate vs. Full) will be determined by the depth of prior MedTech experience and leadership potential.
Key Responsibilities
Technical Manufacturing & Assembly
- Lead Assembly: Hands-on assembly of robotic positioning systems, integrated ultrasound hardware, and MRI-fusion workstations.
- Work Instructions: Execute and refine Work Instructions (WI) and Standard Operating Procedures (SOPs) to ensure consistent builds.
- Troubleshooting: Act as the first line of defense, and in collaboration with R&D, to resolve hardware/software issues during the build phase.
Design Transfer & Continuous Improvement (DFM/DFS)
- Manufacturing Feedback Loop: Translate assembly challenges into Engineering Change Requests (ECR) to improve manufacturability and serviceability.
- Tooling & Jigs: Utilize and provide inputs/feedback for jigs or calibration tools to improve efficiency, increase accuracy, and reduce Procedure Time variability.
- V&V Support: Assist R&D in Verification and Validation (V&V) activities for hardware upgrades and new robotic features.
Operations & Supply Chain Management
- Production Planning: Liaise with vendors and suppliers, and coordinate production schedules based on the commercial forecast to ensure timely delivery to clinical sites.
- BOM & ERP Management: Maintain the Bill of Materials (BOM) and manage inbound/outbound inventory records using the ERP system.
- Shipping & Logistics: Oversee the secure packaging and preparation of medical devices for shipment, ensuring all logistical compliance is met.
Quality & Regulatory Compliance (Liaison with QC)
- DHR Ownership: Responsible for the accurate completion of the Device History Record (DHR) for each unit produced.
- NCR Participation: Identify and document Non-Conformances (NCR). Work closely with the QC Engineer to investigate root causes and implement corrective actions.
- Site Management: Maintain a 5S-compliant, organized, and audit-ready production environment (ISO 13485/FDA QSR).
Requirements & Qualifications
Education: Diploma and above in Mechanical, Mechatronics, or Biomedical Engineering.
Experience: 1-3 years in medical device manufacturing or high-precision robotics.
Technical Skills:
- Ability to read drawings, circuit diagrams, and technical specifications.
- Proven ability to assemble machinery/robotic sub-assemblies, including gearboxes, actuators, and sensor arrays, with high repeatability.
- Proficiency with ERP software and CAD (SolidWorks) for DFM inputs is an advantage.
- Basic understanding of medical device deployment and robotic calibration.
Mindset: A Quality-First attitude with the agility to work in a fast-paced startup environment.
