ATR ID:

ATR226564

Job Title:

Sr Product Engineer

Job Level:

Mechanical Engineers

Duration:

12 months

Location:

Northridge

CA 91325

Education:

B.S in Mechanical, Electrical, Biomedical, or related Engineering field Bachelor's degree or higher in Life Sciences or related discipline

Email:

Wong, Christian

Phone:

408-328-8089

Pay rate:

$45.00 - $56.43 (Hourly)

Benefits:

• Benefits
• Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws. Compensation
• Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select. Work Authorization

ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization. ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees. Role Summary

Product Development & Engineering

Lead end-to-end product development activities including design, prototyping, testing, and validation

Drive technical decisions and provide engineering expertise throughout the product lifecycle

Develop and review engineering specifications, design documents, and technical reports

Identify and resolve complex engineering challenges using systematic problem-solving approaches

Cross-Functional Collaboration

Partner with R D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment

Serve as a technical resource and mentor for junior engineers

Communicate technical concepts clearly to both technical and non-technical stakeholders

Project Leadership

Lead or contribute to multiple concurrent engineering projects

Define project scope, timelines, and deliverables

Track milestones and proactively manage risks and dependencies Quality & Compliance

Ensure products meet regulatory requirements (e.g., ISO, FDA, MDR) and internal quality standards

Support design verification and validation (V&V) activities

Participate in design reviews, FMEAs, risk assessments, and change control processes

Continuous Improvement

Identify opportunities to improve products, processes, and engineering practices

Apply data-driven methods to analyze performance and drive decisions

Stay current with industry trends, emerging technologies, and best practices

Requirement:

Requirements

B.S in Mechanical, Electrical, Biomedical, or related Engineering field

• Bachelor's degree or higher in Life Sciences or related discipline
  
• Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry.
  
• Experience implementing or improving ISO 13485-based QMS.
  
• Strong experience working with Singapore medical device regulatory requirements.
  
• Demonstrated experience supporting or leading

GDPMDS/GDP

certification projects.

• Proven track record of successfully helping organizations obtain and maintain GDP certification
  
• Experience interacting with certification bodies, accreditation bodies, and regulatory authorities.

Experience 5-8+ years of product engineering experience Technical Skills Validation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820 How to

Apply:

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