SMD13
Located in:
Kentwood, MI
Pay: $85,000 - $100,000, commensurate with experience
Job Full Description:
A leading medical device manufacturing company is seeking a highly skilled and experienced Mechanical Engineer to join their team. The ideal candidate will have at least 5 years of experience in mechanical engineering, with a strong background in designing, testing, and improving medical devices. As a key member of the engineering team, the Mechanical Engineer will contribute to the development of innovative and reliable medical products, ensuring they meet regulatory standards and perform safely and efficiently. This position requires strong technical expertise, problem-solving abilities, and the capacity to work collaboratively in a cross-functional team environment.
Mechanical Engineer Responsibilities:
- Design and develop mechanical components and systems for medical devices, ensuring they meet specifications and regulatory standards.
- Conduct feasibility studies, risk assessments, and design verification/validation processes for new product development.
- Work closely with cross-functional teams, including electrical, software, and quality engineering, to integrate mechanical systems into overall device designs.
- Perform detailed analysis, simulations, and testing to evaluate mechanical performance and ensure reliability of devices.
- Manage prototype development, including selecting materials, defining manufacturing processes, and coordinating with vendors.
- Lead failure analysis and root cause investigations, providing recommendations for improvements.
- Ensure compliance with industry regulations such as ISO 13485, FDA regulations, and other relevant standards.
- Prepare and maintain technical documentation, including design reports, specifications, and test plans.
- Participate in design reviews and provide technical support throughout the product lifecycle.
- Collaborate with the manufacturing team to ensure efficient production processes and product quality.
- Mentor junior engineers and provide guidance on complex technical challenges.
Schedule: Full-time, Monday - Friday, 40 hours per week.
Job Experience
- 5+ years of mechanical engineering experience, preferably in the medical device or regulated industries.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for designing mechanical components and systems.
- Strong knowledge of materials science, manufacturing processes, and mechanical testing methods.
- Experience with design for manufacturability (DFM) and design for assembly (DFA) principles.
- Understanding of regulatory requirements, including ISO 13485, FDA, and CE marking.
- Proven ability to perform finite element analysis (FEA) and other simulation-based evaluations.
- Strong problem-solving, troubleshooting, and analytical skills.
- Ability to work collaboratively in a team environment and communicate technical information clearly.
- Excellent time management and organizational skills, with the ability to manage multiple projects and deadlines.
- Familiarity with risk management processes such as FMEA and DFMEA is a plus.
Kentwood, MI
Susan Delauter
Susan.Delauter@SRGexpress.com
616-608-9681
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