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Senior Electro Mechanical Engineer
2 months ago
Senior Electro Mechanical Engineer Medical Products
Location: Minneapolis, MN USA. (100% onsite at client location)
Duration: 12 months
Position Overview:
We are looking for an experienced Senior System Engineer with hands-on expertise in mechanical and electrical systems for medical products. The ideal candidate will have a strong background in sterilization, temperature monitoring equipment, and biological indicator incubators. This role requires extensive experience in the change control process, cross-functional team collaboration, and global team coordination.
Key Responsibilities:
- Mechanical and Electrical Expertise: Design, develop, and sustain mechanical and electrical systems for medical products, including sterilization and temperature monitoring equipment and biological indicator incubators.
- Change Control Process: Manage and execute change control processes to ensure compliance with regulatory standards and maintain product quality.
- Cross-Functional Team Collaboration: Work closely with quality, regulatory, manufacturing, and supply chain teams (both internal and external) to execute and implement tasks and drive projects to completion.
- Alternate Part Identification: Identify and qualify alternate parts to ensure product continuity and cost efficiency.
- Global Team Coordination: Coordinate with global teams, including onsite and offshore resources, to ensure seamless project execution and communication.
- Project Management: Lead and manage projects, ensuring timely delivery and adherence to quality standards.
- Documentation and Compliance: Maintain detailed documentation to support compliance with regulatory requirements and internal standards.
Qualifications:
- Education: Bachelor's degree in Engineering is required; a Master's degree in Engineering is preferred.
- Experience: Minimum of 10 years of experience working with medical device manufacturers.
Skills:
- Strong mechanical and electrical engineering skills.
- In-depth knowledge of sterilization and temperature monitoring systems.
- Proven experience with change control processes.
- Ability to work effectively with cross-functional teams.
- Experience in identifying and qualifying alternate parts.
- Strong project management and leadership skills.
- Excellent communication and coordination skills for global team management.
- Regulatory Knowledge: Familiarity with regulatory requirements and standards for medical devices (e.g., ISO 13485, EU-MDR).