Product Engineer III - Nitinol

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 injection molding, laser processing, metal stamping, and device assembly.

About the role

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 products, components, and assemblies. This role partners with product teams, 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.

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 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.

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, 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.

Skills

• Experience working in contract manufacturing, medical device manufacturing (ISO 13485/FDA regulated).
• Experience working with Nitinol manufacturing process development.
• Continuing education, including participation in local chapters, associations, and/or organizations.

Benefits

All Employees:

• 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.

20+ hours per week:

• 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 and paid time off.
• Discretionary profit-sharing program.

30+ hours per week:

• Parental Leave.
• Accident and critical illness benefits.
• Optional employee, spouse, and child life insurance.
• Short and long-term disability.
• Company-provided life insurance.
• Tuition assistance programs.

(Some benefits are subject to eligibility criteria.)

Pay

USD $90,800.00 - USD $136,200.00 per year. This pay range reflects the base annual salary for positions within this job grade, based on market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.