Product Engineer III - Nitinol
About The Position
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.
Requirements
- 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, and risk management processes.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and familiarity with simulation tools.
- Experience with materials selection, manufacturing processes, and product testing methodologies.
- Excellent analytical and problem-solving skills.
- Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.
- Ability to work in a manufacturing environment.
- Ability to travel up to 10% of the time.
Nice To Haves
- Continuing Education; including participation in local chapters, associations, and/or organizations.
- Experience working in contract manufacturing, medical device manufacturing (ISO 13485/FDA regulated)
- Experience working with Nitinol manufacturing process development.
Responsibilities
- 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.
- 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.
- 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.
- Work closely with manufacturing, quality assurance, product management, and commercial teams to align technical execution with product goals, project timelines, and customer requirements.
- 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.
- 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.
Benefits
- 401k retirement savings plan with a company match contribution
- Onsite health clinics
- Discretionary holiday bonus program (based on years of service)
- Cretex University
- 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost
- Wellness program with incentives
- Employee death benefit
- Employee sick and safe leave
- Comprehensive medical insurance with access to virtual providers
- Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)
- Vision insurance
- Pre-tax health savings account
- Healthcare and dependent care pre-tax reimbursement accounts
- Paid holidays
- Paid time off
- Discretionary profit sharing program
- Parental Leave
- Accident and critical illness benefits
- Optional employee, spouse, and child life
- Short and long term disability
- Company provided life insurance
- Tuition assistance programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
