Product Design Engineer

Pride Health; San Antonio (TX); On-site; USD 41,328 - 55,104; Full time

Benefits offered by this job

Healthcare coverage

401(k) retirement plan

Life & disability insurance

Employee assistance program

Identity theft protection

Legal support

Auto and home insurance

Pet insurance

Employee discounts

Job summary

Pride Health's Science Team in San Antonio, TX seeks a Product Design Engineer II to support medical device product development and sustaining engineering efforts. You will drive design changes, create ECOs/ECPs, and collaborate across Manufacturing, Quality, Regulatory, and Product Development to ensure robust design controls throughout the lifecycle.

The role balances concept-to-implementation work with documentation, testing, and investigations, requiring a bachelor’s in a related engineering

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline.
• Minimum of 3 years of engineering experience within the medical device industry.
• Experience creating Engineering Change Plans (ECPs), Engineering Change Orders (ECOs), or similar documentation.
• Experience managing and maintaining Bills of Materials (BOMs).
• Knowledge of medical device design controls and regulated product development.
• Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
• Strong understanding of mechanical engineering principles.
• Experience supporting verification and validation activities.
• Proficiency with Microsoft Office applications, including Excel, Word, and Project.
• Strong analytical, problem‑solving, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively within cross‑functional teams.

Responsibilities

• Lead design change initiatives under the guidance of senior engineers.
• Support product and process change projects from concept through implementation.
• Drive timely resolution of engineering‑related issues and technical investigations.
• Collaborate with cross‑functional teams including Manufacturing, Quality, Regulatory, Validation, and Product Development.
• Develop engineering documentation, including ECOs, ECPs, and technical reports.
• Create and maintain specifications for components, assemblies, packaging, and labeling.
• Partner with Verification & Validation teams to develop test protocols and validation documentation.
• Perform engineering analyses and product testing to verify designs meet functional and performance requirements.
• Analyze test data using statistical methods and prepare technical reports with findings and recommendations.
• Participate in product failure investigations and root cause analysis.
• Support risk management activities in accordance with applicable medical device standards.
• Ensure compliance with Design Control processes and applicable quality system regulations.
• Identify opportunities for product improvements, cost reductions, and manufacturing optimization.
• Participate in brainstorming and design reviews to develop innovative engineering solutions.

Skills

Mechanical engineering principles

Analytical thinking

Cross-functional collaboration

Documentation accuracy

Independent work

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or Chemical Engineering

Tools

Engineering Change Orders (ECOs)

Engineering Change Plans (ECPs)

Bills of Materials (BOMs)

Job description

The Science Team at Pride Health supporting the Material Sciences Industry that has an opening for Product Design Engineer in San Antonio, TX

Position Summary

We are seeking a Product Design Engineer II to join a cross‑functional engineering team supporting medical device product development and sustaining engineering initiatives. In this role, you will contribute to product and process improvements, engineering change activities, product investigations, verification and validation testing, technical documentation, and design control compliance. You will collaborate with engineering, manufacturing, quality, regulatory, and validation teams to support projects throughout the product lifecycle.

Additional Details

Contract Length: 12 Months with the possibility of extensions

Pay range: $30 to $40 per hour on W2 (As per experience)

Responsibilities

• Lead design change initiatives under the guidance of senior engineers.
• Support product and process change projects from concept through implementation.
• Drive timely resolution of engineering‑related issues and technical investigations.
• Collaborate with cross‑functional teams including Manufacturing, Quality, Regulatory, Validation, and Product Development.
• Develop engineering documentation, including Engineering Change Orders (ECOs), Engineering Change Plans (ECPs), and technical reports.
• Create and maintain specifications for components, assemblies, packaging, and labeling.
• Partner with Verification & Validation teams to develop test protocols and validation documentation.
• Perform engineering analyses and product testing to verify designs meet functional and performance requirements.
• Analyze test data using statistical methods and prepare technical reports with findings and recommendations.
• Participate in product failure investigations and root cause analysis.
• Support risk management activities in accordance with applicable medical device standards.
• Ensure compliance with Design Control processes and applicable quality system regulations.
• Identify opportunities for product improvements, cost reductions, and manufacturing optimization.
• Participate in brainstorming and design reviews to develop innovative engineering solutions.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline.
• Minimum of 3 years of engineering experience within the medical device industry.
• Experience creating Engineering Change Plans (ECPs), Engineering Change Orders (ECOs), or similar engineering change documentation.
• Experience managing and maintaining Bills of Materials (BOMs).
• Knowledge of medical device design controls and regulated product development.
• Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
• Strong understanding of mechanical engineering principles.
• Experience supporting verification and validation activities.
• Proficiency with Microsoft Office applications, including Excel, Word, and Project.
• Strong analytical, problem‑solving, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively within cross‑functional teams.

Preferred Qualifications

• Experience working in FDA‑regulated or ISO‑certified product development environments.
• Internship or early‑career experience supporting regulated medical device development.
• Experience with statistical analysis of engineering test data.
• Knowledge of manufacturing processes and Design for Manufacturability (DFM) principles.

Must be authorized to work in the United States.

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.