Senior Design Quality Engineer – NPD for Medical Devices

Antler; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation –120 hours per year

Sick time – 40 hours per year

Holiday pay –13 days per year

Parental Leave – 480 hours

401(k) / retirement plan

Long-term incentive program

Job summary

Antler in Santa Clara, CA seeks a Senior Design Quality Engineer to lead quality aspects of New Product Development. You will guide design controls, risk management, and verification/validation to ensure regulatory compliance and robust product launches.

Ideal candidates hold a engineering degree and 5+ years in quality within regulated environments; GD&T knowledge and cross‑functional teamwork are essential. Domestic/international travel up to 25% may be required.

Qualifications

• Bachelor’s Degree in Engineering from an accredited engineering school or related science field.
• At least 5 years of quality experience.
• New product development experience.
• GD&T knowledge.
• Experience in medical device industry or other highly regulated field.
• Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity.
• Previous work experience engaging in a team-based environment.
• Ability to travel up to 25% Moderate domestic and international.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady‑state processes.
• Drive development of product requirements, verification and validation strategies.
• Ensure compliance to GMP, ISO and other applicable standards.
• Pursue defect prevention and continuous improvement in design.
• Collaborate with partners to resolve issues in a timely fashion.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation documents.
• Develop inspection and sampling plans, test methods, and transfer functions.
• Support reliability strategy during new product development.
• Lead technical projects with responsibility.

Skills

Quality engineering

New product development

GD&T knowledge

Statistics / applied statistics

Team collaboration

Travel up to 25%

Education

Bachelor’s Degree in Engineering or related science

Advanced Degree

Tools

ASQ Certified Quality Engineer

ASQ Certified Reliability Engineer

Six Sigma Green Belt

Job description

Antler in Santa Clara, CA seeks a Senior Design Quality Engineer to lead quality aspects of New Product Development. You will guide design controls, risk management, and verification/validation to ensure regulatory compliance and robust product launches.

Ideal candidates hold a engineering degree and 5+ years in quality within regulated environments; GD&T knowledge and cross‑functional teamwork are essential. Domestic/international travel up to 25% may be required.