Mechanical Engineer - MedTech Instrument Design

Gener8,-LLC; Carlsbad (CA); On-site; USD 87,000 - 116,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Life insurance

Short-term disability

Long-term disability

Flexible spending account

Health savings account

Paid time off

Paid holidays

Bereavement leave

Jury duty paid time off

Employee discounts

Referral program

Job summary

Gener8, LLC in Carlsbad, California is seeking a Mechanical Engineer to join the platform engineering mechanical team. You will work on current and next-generation mechanical designs of medical instruments in a dynamic, fast-paced environment.

The role emphasizes problem-solving, cross-functional collaboration, and adherence to FDA/ISO quality systems to support design inception through manufacturing release.

Qualifications

• Relevant experience in the mechanical design of computer/network equipment designed to operate in data centers.
• Knowledge of cross-functional design areas such as Interconnects, SI, PCB, EMI, safety, and thermal.
• Actively participating and contributing to industry standard organizations.
• Problem-solving and analytical skills.
• Expertise in analyzing, troubleshooting and resolving complex issues.
• Ability to balance the needs of a fast-paced start-up environment with the needs for good documentation and quality control.
• Knowledge and competency in application of FDA, ISO 13485, ISO 14971, MDR, and other regulatory requirements, especially in the area of quality systems and design control as applied to projects from design inception to manufacturing release, is required.

Responsibilities

• Develop innovative solutions to complex problems.
• Conduct failure analysis efforts and develop mitigation plans for field and manufacturing related issues.
• Actively engage in external technical community.

Skills

Problem-solving

Analytical skills

Teamwork

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

Gener8, LLC in Carlsbad, California is seeking a Mechanical Engineer to join the platform engineering mechanical team. You will work on current and next-generation mechanical designs of medical instruments in a dynamic, fast-paced environment.

The role emphasizes problem-solving, cross-functional collaboration, and adherence to FDA/ISO quality systems to support design inception through manufacturing release.