Validation engineer Jobs in Allen, TX

Mechanical Engineer
Plano, TX (On-Site) | Direct-Hire | $120,000–$140,000 Base Salary

Konik is partnering with a global manufacturer of specialized medical devices to add a Mechanical Engineer to their team. This organization develops innovative, minimally invasive products used in image-guided procedures, with a strong focus on improving patient outcomes through advanced design and engineering.

This role is ideal for an experienced engineer who thrives in end-to-end product development, owning projects from concept through commercialization while working in a highly regulated, design-controlled environment.

Mechanical Engineer Responsibilities

• Lead mechanical design and development of medical device products, from concept through launch
• Translate product and system requirements into innovative design solutions
• Develop detailed 3D models, drawings, and specifications using SolidWorks
• Perform tolerance stack-ups, GD&T, and statistical analysis to ensure product performance
• Support design control activities including DFMEA, risk analysis, and documentation
• Conduct and support testing activities, including engineering confidence testing (ECT) and validation efforts
• Perform FEA and other analyses to validate design performance and safety
• Apply DFM/DFA principles to optimize manufacturability and assembly
• Collaborate with vendors to prototype, test, and refine product designs
• Lead design reviews and drive continuous improvement of existing products
• Investigate materials, processes, and design enhancements to improve performance and reliability
• Perform root cause analysis and implement design changes as needed

Additional Role Details

• Full ownership of product development lifecycle from concept to commercialization
• Highly collaborative environment working with engineering, quality, and manufacturing teams
• Exposure to cutting-edge medical technologies and applications
• Opportunity to influence both new product development and continuous improvement efforts

Mechanical Engineer Qualifications

• Bachelor’s degree in Mechanical Engineering required
• 5+ years of experience in medical device product development with disposable devices
• Strong experience with SolidWorks and mechanical design tools
• Proficiency in GD&T, tolerance analysis, and detailed drawing creation
• Experience working within design control and regulated environments
• Knowledge of plastics, injection molding, and manufacturing processes
• Experience with DFMEA, risk mitigation, and validation methodologies
• Strong problem-solving and analytical skills

Preferred Experience

• Experience with catheter-based or minimally invasive medical devices
• Background in mold flow analysis or advanced simulation tools
• Experience supporting verification and validation (V&V) activities
• Familiarity with regulatory standards for medical device development

Compensation & Benefits

• Performance-based bonus opportunities (10%)
• Comprehensive medical, dental, and vision benefits
• 401(k) with employer contribution
• PTO and paid holidays
• Career growth within a global, innovation-driven organization

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Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been a leader in the technical staffing industry for more than 50 years, providing the fastest and easiest link between employees and employers. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.