Product Engineer III - Nitinol

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry.  Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly.  Learn more at www.cretexmedical.com.

 

Position Summary 

The Product Engineer III - Nitinol is responsible for providing technical expertise and hands-on execution in support of nitinol component and device development, including the design, specification, validation, and manufacturing support of assigned product, components, and assemblies. This role  partners with the product team, Engineering, Quality, Manufacturing, and commercial teams to translate product and technology strategies into practical project plans, technical deliverables, and process improvements. The Product Engineer serves as the engineering engine of the team, executing day-to-day technical activities including New Product Introductions (NPI), customer-specific application development, testing, troubleshooting, capability development, and documentation. This role also generates accurate technical data and specifications required for fast, margin-conscious quoting. Applying materials expertise, process knowledge, and engineering judgment, the Product Engineer serves as a trusted technical resource, identifying execution needs, risks, and technical gaps that may impact project success while ensuring compliance with safety, regulatory, and performance requirements.

 

Responsibilities

Customer & Market-Focused Engineering

• Partner with product and commercial teams to understand customer and market needs, then support the execution of technical improvements that strengthen Cretex’s capabilities in medtech segments requiring nitinol components.
• Deliver strategic initiatives by developing and executing technical action plans, completing assigned engineering deliverables, and communicating progress, risks, and resource needs.
• Support quoting activities for new business by reviewing technical requirements, identifying process assumptions, and providing engineering input on feasibility, risks, and development needs.
• Collaborate with customers on their designs as early as possible to influence optimal development and process capability.

Engineering Documentation & Compliance

• Support the engineering team on necessary documentation, including specifications, material requirements, drawings, and test plans.
• Ensure compliance with FDA regulations, ISO 13485, and other relevant standards throughout the product lifecycle.

Product Development, Validation & Technical Execution

• Execute and support comprehensive test plans, with input from other engineering resources, to validate performance of new or improved capabilities in terms of reliability, safety, manufacturability, and scalability.
• Analyze test results, troubleshoot issues, and recommend design improvements based on findings.
• Provide technical support during production, addressing engineering-related issues that arise.

Cross-Functional Collaboration

• Work closely with manufacturing, quality assurance, product management, and commercial teams to align technical execution with product goals, project timelines, and customer requirements.

Project Management & Reporting

• Manage assigned technical workstreams and multiple project priorities concurrently, ensuring timely completion of deliverables and adherence to project milestones.
• Report on project status and engineering metrics to stakeholders.

Continuous Improvement & Technical Expertise

• Stay informed on industry trends, emerging technologies, and best practices in medical device design and manufacturing.
• Identify and implement tactical process improvements to enhance product quality, manufacturability, efficiency, and technical capability.
• Build technical expertise in Nitinol processing to become a trusted internal resource for laser cutting, shape-setting, electropolishing, material characterization, and process troubleshooting.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or a related field); Master’s degree preferred.
• 5 years of experience in engineering, specifically within the medical device industry.
• Advanced working knowledge of engineering principles with the ability to apply them to tactical project execution, problem solving, testing, and process improvement.
• Strong knowledge of medical device regulations, quality systems,