Mechanical Engineer

Job DescriptionJob Description

Join Our Team as a Mechanical Engineer – Be a Leader in Designing Cutting-Edge Medical Devices!

Are you ready to make a difference in the world of healthcare innovation? We are seeking a passionate and skilled Mechanical Engineer to join our dynamic engineering team. In this role, you'll have the opportunity to design and redefine electro-mechanical medical devices that save lives and improve patient outcomes. If you thrive in a collaborative, fast-paced environment and are motivated by solving complex challenges, this is the role for you!

What You’ll Do:

• Innovate and Design: Develop and redesign FDA, ISO 13485, CE, ISO 14971, MDD 93/42/EEC, and MDR-compliant medical devices that revolutionize pre-hospital patient handling.
• Drive Compliance: Ensure alignment with Engineering Change Order and Phase-Gate processes, meeting QMS requirements.
• Collaborate and Contribute: Work with cross-functional teams to create robust design and material specifications, prototypes, and technical solutions.
• Enhance Quality: Lead tolerance stack-ups, DFM (Design for Manufacturability), DFA (Design for Assembly), DFS (Design for Sustainability), FMEA development, and usability assessments.
• Own the Process: Maintain design history and technical files, ensuring all controlled documents meet stringent regulatory standards.
• Validate Excellence: Review verification and validation test plans, providing actionable feedback to enhance product reliability.
• Optimize and Support: Develop solutions to improve quality, reduce costs, and address field issues with effective corrective actions.
• Lead Communication: Act as the primary contact for internal and external stakeholders, offering escalation support and updates on assigned programs.
• Master the Tools: Use CAD (SolidWorks experience required) to maintain and update detailed design drawings and models.

Why You’ll Love This Role:

• You’ll contribute to life-saving innovations that impact global healthcare.
• You’ll be at the forefront of medical device design, pushing boundaries and exploring new technologies.
• You’ll join a collaborative team that values creativity, problem-solving, and excellence.
• You’ll grow your expertise in a highly regulated, cutting-edge industry.

What We’re Looking For:

• Experience: A strong background in electro-mechanical design, particularly within FDA, ISO 13485, and other medical device standards.
• Problem Solver: Ability to diagnose field issues and drive effective corrective actions.
• Collaborator: A team player who thrives in cross-functional environments.
• Technical Expert: Proficiency in CAD software (SolidWorks required), and a deep understanding of regulatory compliance.
• Innovator: A passion for improving product quality and reducing costs through creative engineering solutions.

Join us and be part of a team where your designs directly improve lives around the world. If you’re ready to advance your career while making a meaningful impact, apply today!

Company DescriptionGentis believes in treating employees and contractors as mission-critical! We offer both employee and contractor packages, with compensation traditionally higher than the industry average.Company DescriptionGentis believes in treating employees and contractors as mission-critical! We offer both employee and contractor packages, with compensation traditionally higher than the industry average.