Senior Design Quality Engineer, NPD

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

Job Function

R&D Product Development

Job Sub Function

R&D Software/Systems Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Santa Clara, California, United States of America

Job Description

The Senior Design Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady‑state processes.
• Drives the development of product requirements, verification strategies, and validation strategies.
• Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
• Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Proactively engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
• Develop inspection and sampling plans, test methods, and transfer functions for products and components.
• Provide support and expertise in developing and executing a reliability strategy during new product development.
• Conducts projects and assignments with technical responsibility.

Required

Basic 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 knowlegde
• 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

Preferred

• Advanced Degree
• Experience with medical electrical-mechanical systems
• Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment.
• ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
• Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
• Prior software quality engineering experience in a product development environment

Preferred Skills:

Analytical Reasoning, Quality Compliance, Quality Control (QC), Quality Planning, Quality Tools, Quality Validation, Risk Analysis

The anticipated base pay range for this position is :

$125,000.00 - $201,250.00

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.