What are the responsibilities and job description for the Medical Device Development Manager position at Realta Technologies?
Job Overview
Ralta Technologies is a leading provider of innovative medical device solutions. We are seeking an experienced and detail-oriented Project Manager to support our key client in the Medical Device industry.
Key Responsibilities:
Ralta Technologies is a leading provider of innovative medical device solutions. We are seeking an experienced and detail-oriented Project Manager to support our key client in the Medical Device industry.
Key Responsibilities:
- Lead end-to-end project management of 3D printed component development, from concept to validation and transfer to production.
- Collaborate with design, engineering, quality, and regulatory teams to define and manage project scope, timelines, deliverables, and budgets.
- Manage prototyping activities using 3D printing technologies (e.g., SLA, SLS, FDM, DMLS) and support iteration cycles based on design feedback.
- Develop and execute validation plans, including IQ/OQ/PQ protocols, risk assessments, and test reports in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
- Track project progress and provide regular updates to stakeholders, identifying and mitigating risks proactively.
- Ensure design control compliance throughout the project lifecycle, including documentation, change control, and traceability.
- Act as the primary point of contact between internal teams and the client, fostering clear communication and alignment on goals and expectations.
- Support regulatory submissions by providing technical documentation and validation evidence.
- Lead or participate in cross-functional meetings, design reviews, and CAPA activities related to additive manufacturing.
