Senior Quality Assurance Engineer

Comrise; Lubbock (TX); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A leading company in medical technology is seeking a hybrid R&D and Quality Engineer. You will play a vital role in new product development, ensuring the safety and effectiveness of medical devices while collaborating with multiple teams to enhance patient outcomes. Ideal candidates will have a Bachelor's in Engineering and relevant experience in R&D.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Bioengineering, Materials Science, or related fields.
• At least 2 years of engineering experience.
• Experience with medical device regulations like ISO 13485 and ISO 14971.

Responsibilities

• Ensure implementation of cutting-edge technology for medical devices.
• Work closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs.
• Contribute to the success of the company and improve patient outcomes.

Skills

Technical engineering expertise

Basic statistics analysis

Design verification

Statistical analysis

Education

Bachelor's degree in Engineering

Job description

You will be a key member of the new product development team, ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices.

Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will operate in a fast-paced environment with opportunities to contribute to the success of the company and improve patient outcomes worldwide.

This position is a hybrid role combining elements of a traditional R&D Engineer and a Quality Engineer.

Candidate must reside within a commutable distance to Tempe, AZ, and is expected to be onsite at least 3 days per week. This role is not fully remote.

Required Qualifications:

• Bachelor's degree in Engineering, preferably in Mechanical, Electrical, Bioengineering, Materials Science, or related fields
• At least 2 years of engineering experience
• Experience in R&D and Quality Engineering preferred
• Technical engineering expertise required
• Experience with design verification and statistical analysis
• Research & Development engineering background preferred
• Basic statistics analysis skills
• Experience with design verification & validation
• Knowledge of standard medical device regulations
• Familiarity with ISO 13485 and ISO 14971 standards

Preferred candidates would have experience in the Medical Devices industry, but this is not a strict requirement.