Project Manager

Réalta Technologies are seeking an experienced and detail-oriented Project Manager with a strong background in 3D printing, validation, and medical device development to support a key client in the Medical Device industry. The successful candidate will be responsible for leading cross-functional project teams, ensuring the successful planning, execution, and delivery of 3D printed medical device components from concept through validation and into production.

This role requires a strong understanding of additive manufacturing processes, regulatory requirements, and product lifecycle management in a medical device environment.

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. Required Qualifications & Skills:

Bachelor's degree in Engineering, Materials Science, Biomedical Engineering, or a related field. Advanced degree a plus.

Minimum 5 years of project management experience, with at least 2 years in the Medical Device industry.

Hands-on experience with 3D printing/additive manufacturing, including familiarity with relevant technologies and materials.

Proven track record of managing validation activities for medical devices or components (IQ, OQ, PQ).

Strong knowledge of design controls, risk management (ISO 14971), and regulatory requirements for medical devices (FDA, MDR, ISO 13485).

Exceptional organizational and communication skills, with the ability to lead cross-functional teams and interface directly with clients.

Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet) and documentation systems (e.g., PLM, eQMS).

PMP or equivalent project management certification is preferred.