Senior Electro Mechanical Engineer – Medical Products ONSITE / USC/GC/H4EAD/ L2EAD

Raag Solutions; Minnesota; On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a seasoned engineer with a robust background in mechanical and electrical systems for medical devices. This role involves designing innovative solutions, managing projects, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to drive projects to completion while maintaining product quality. If you have a passion for engineering and a desire to make an impact in the medical field, this opportunity is perfect for you.

Qualifications

• 10+ years of experience in medical device manufacturing.
• Strong skills in mechanical and electrical engineering.

Responsibilities

• Design and develop mechanical and electrical systems for medical products.
• Manage change control processes and ensure compliance with standards.

Skills

Mechanical Engineering

Electrical Engineering

Sterilization Systems

Temperature Monitoring Systems

Change Control Processes

Project Management

Cross-Functional Team Collaboration

Regulatory Knowledge

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

SHOULD WORK IN W2
ONSITE - USC/GC/H4EAD/ L2EAD

Key Responsibilities:

1. 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.
2. Change Control Process: Manage and execute change control processes to ensure compliance with regulatory standards and maintain product quality.
3. 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.
4. Alternate Part Identification: Identify and qualify alternate parts to ensure product continuity and cost efficiency.
5. Global Team Coordination: Coordinate with global teams, including onsite and offshore resources, to ensure seamless project execution and communication.
6. Project Management: Lead and manage projects, ensuring timely delivery and adherence to quality standards.
7. Documentation and Compliance: Maintain detailed documentation to support compliance with regulatory requirements and internal standards.

Qualifications:

1. Education: Bachelor’s degree in Engineering is required; a Master’s degree in Engineering is preferred.
2. Experience: Minimum of 10 years of experience working with medical device manufacturers.

Skills:

1. Strong mechanical and electrical engineering skills.
2. In-depth knowledge of sterilization and temperature monitoring systems.
3. Proven experience with change control processes.
4. Ability to work effectively with cross-functional teams.
5. Experience in identifying and qualifying alternate parts.
6. Strong project management and leadership skills.
7. Excellent communication and coordination skills for global team management.
8. Regulatory Knowledge: Familiarity with regulatory requirements and standards for medical devices (e.g., ISO 13485, EU-MDR).