Product Design Engineer

Pride Global; San Antonio (TX); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Comprehensive health/dental/vision

401(k) retirement plan

Life & disability insurance

Job summary

Pride Health invites applications for a Product Design Engineer II in San Antonio, TX. The role supports medical device development, documentation, and design control compliance within a cross-functional team.

The incumbent will lead design changes, contribute to ECOs/ECPs, and collaborate with Manufacturing, Quality, Regulatory, Validation, and Product Development. A 12-month contract with hourly pay of $30–$40 is offered, with US work authorization required.

Qualifications

• Bachelor's degree in a related engineering discipline.
• Minimum of 3 years of engineering experience within the medical device industry.
• Experience creating Engineering Change Plans (ECPs) or Engineering Change Orders (ECOs).
• Experience managing Bills of Materials (BOMs).
• Knowledge of medical device design controls and regulated product development.
• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971.

Responsibilities

• Lead design change initiatives under guidance from senior engineers.
• Support product and process change projects from concept through implementation.
• Drive timely resolution of engineering issues and investigations.
• Collaborate with cross-functional teams (Manufacturing, Quality, Regulatory, Validation, Product Development).
• Develop ECOs, ECPs, and technical reports.
• Create specifications for components, assemblies, packaging, and labeling.
• Develop test protocols and validation documentation with V&V teams.
• Perform analyses and testing to verify design requirements.
• Analyze test data and prepare technical reports with findings.
• Participate in failure investigations and root-cause analysis.
• Support risk management per medical device standards and design controls.

Skills

3+ yrs medical device experience

ECOs/ECPs

MS Office (Excel/Word/Project)

Analytical/problem solving

Education

Bachelor's in Mechanical/Biomedical/Chemical Eng

Tools

BOM management

Design controls knowledge

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.

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