What are the responsibilities and job description for the Mechanical Engineer. position at Pentangle Tech?
The Mechanical Engineer will play a crucial role in the testing and prototyping of medical devices. This position requires a versatile engineer with a strong background in mechanical engineering principles, hands-on prototyping skills, and a keen eye for detail. The successful candidate will work closely with cross-functional teams to ensure the reliability, safety, and efficacy of our products.
Key Responsibilities:
Design, develop, and test prototypes of medical devices.
Understand when hand calculations are acceptable vs simulations
Executing engineering analyses
Perform tolerance analysis.
Conduct mechanical testing and analysis to validate design concepts.
Collaborate with R&D, manufacturing, and quality assurance teams to refine prototypes and ensure manufacturability.
Develop and execute test plans, protocols, and reports.
Utilize CAD software to create detailed design drawings and specifications.
Perform root cause analysis and implement corrective actions for design and process issues.
Stay current with industry standards and regulatory requirements for medical devices.
Document all testing and prototyping activities in accordance with company policies and regulatory guidelines.
Additional Skills & Qualifications
Qualifications:
Bachelor's degree in Mechanical Engineering or a related field.
5 years of experience in mechanical engineering, preferably in the medical device industry.
Proficiency in Creo CAD software.
ASME Y14.5 or ISO drafting proficiency.
Strong understanding of mechanical testing methods and equipment.
Excellent problem-solving skills and attention to detail.
Ability to work effectively in a team environment and communicate clearly with cross-functional teams.
Knowledge of regulatory standards for medical devices (e.g., ISO 13485, FDA regulations) is a plus.
Preferred Skills:
Experience with rapid prototyping techniques (e.g., 3D printing, CNC machining).
Hands-on experience with mechanical testing equipment (e.g., tensile testers, fatigue testers).
