Orthotic Device Testing and Validation Engineer – Omaha, NE

 

Orthotic Device Testing and Validation Engineer – Omaha, NE

Are you ready to contribute to the cutting-edge world of orthotic device testing and validation? We are seeking an experienced Orthotic Device Testing and Validation Engineer in Omaha, NE, to play a pivotal role in the development of life-enhancing medical devices. This is a fantastic opportunity to apply your expertise in testing methodologies and validation processes to create high-quality, safe, and effective orthotics that improve patient mobility and comfort. If you have a passion for engineering solutions that make a difference, we want you on our team.

Drive Excellence in Orthotic Device Development

A leading company in Omaha, NE is looking for an Orthotic Device Testing and Validation Engineer to support the creation of groundbreaking orthotic devices. The ideal candidate will have a strong engineering background and expertise in testing, validation, and regulatory compliance within the medical device industry. This role offers the opportunity to work with a dynamic team, ensuring that orthotics meet the highest standards of performance and safety. If you’re ready to make an impact in a growing field, this is your chance to join a team dedicated to improving patient outcomes and advancing orthotic technology.

Key Responsibilities of the Orthotic Device Testing and Validation Engineer – Omaha, NE

Device Testing & Validation: Lead and execute rigorous testing protocols to validate the performance, safety, and compliance of orthotic devices. Ensure all devices meet or exceed regulatory standards and are ready for market release, collaborating with design and engineering teams to conduct functional testing, durability assessments, and usability evaluations.

Quality Assurance & Compliance: Ensure that orthotic devices comply with industry standards and regulations, including FDA and ISO guidelines. Implement and maintain effective quality control processes, conduct risk assessments, and manage documentation to ensure compliance at every stage of development.

Cross-functional Collaboration: Work closely with product development, design, and manufacturing teams to ensure seamless integration of testing and validation into the product development lifecycle. Provide technical insights and recommendations to improve product design, functionality, and manufacturability.

Test Methodology Development: Develop and refine testing methodologies and protocols for various orthotic products, ensuring they are scientifically valid, reproducible, and aligned with industry best practices. Stay up-to-date with the latest advancements in testing technology and industry standards.

Reporting & Documentation: Maintain comprehensive testing documentation, including test plans, reports, and results, ensuring transparency and traceability of all validation processes. Provide regular updates to stakeholders regarding testing progress, challenges, and product performance.

Data Analysis & Problem Solving: Analyze test data to identify potential design flaws, failure modes, and improvement opportunities. Utilize statistical analysis and problem-solving techniques to provide data-driven solutions that enhance the product’s overall quality and reliability.

Continuous Improvement: Drive continuous improvement initiatives by identifying areas of enhancement in testing procedures, device performance, and overall quality. Proactively seek ways to improve product quality, reduce costs, and streamline testing processes without compromising safety or performance.

Risk Management & Mitigation: Identify potential risks related to orthotic device functionality and patient safety during testing. Work with cross-functional teams to develop risk mitigation strategies and ensure that any risks are appropriately managed through design adjustments or process improvements.

Customer & User Feedback Integration: Incorporate feedback from end-users and healthcare professionals into the testing and validation process to ensure that orthotic devices meet user needs, comfort, and performance expectations.

What the Client is Looking for in You

As the Orthotic Device Testing and Validation Engineer in Omaha, NE, the client seeks a highly skilled professional who brings expertise in orthotic device testing, validation, and quality assurance. You should have a strong understanding of medical device regulations, a keen eye for detail, and the ability to work effectively in a collaborative environment. The ideal candidate will be passionate about improving patient outcomes and advancing the field of orthotics through rigorous testing and validation processes.

Proven Experience in Medical Device Testing and Validation

The client is looking for an individual with hands-on experience in testing and validating medical devices, particularly within the orthotic or healthcare sector. You should be proficient in developing test plans, conducting performance evaluations, and ensuring that products meet safety, regulatory, and quality standards. A strong background in engineering, mechanical testing, or biomedical fields will be crucial to succeed in this role.

Knowledge of Regulatory Standards and Compliance

As an Orthotic Device Testing and Validation Engineer, you must possess in-depth knowledge of industry regulations, such as FDA and ISO standards, and ensure that all testing and validation activities comply with these guidelines. The client is seeking someone who can navigate the regulatory landscape with confidence, ensuring the highest level of quality and safety in every product tested.

Attention to Detail and Analytical Skills

The ideal candidate should have exceptional attention to detail, analytical thinking, and the ability to identify potential design flaws and improvement opportunities. The client is looking for someone who can accurately interpret test data, identify trends, and suggest corrective actions. Your ability to troubleshoot issues and provide innovative solutions will be essential in ensuring the devices meet the highest standards of functionality and safety.

Collaborative and Cross-Functional Team Player

The client values team collaboration and seeks a candidate who can work effectively with design, engineering, and manufacturing teams. You should be able to provide clear feedback, influence product design, and contribute to product development cycles, ensuring smooth transitions from design to production. Strong communication skills and the ability to work in a cross-functional environment are key to this role.

Commitment to Continuous Improvement and Innovation

The ideal candidate will demonstrate a passion for continuous improvement and staying at the forefront of testing and validation technologies. The client is looking for someone who can not only maintain existing processes but also drive innovation in testing methodologies, improving both efficiency and product quality.

Strong Problem-Solving and Risk Management Abilities

The client values an individual who can quickly identify and mitigate risks related to orthotic device performance and safety. Your ability to conduct thorough risk assessments and implement solutions to minimize issues will be critical in ensuring the reliability and safety of the devices.

Ability to Manage Documentation and Reporting

Effective documentation is essential in this role, and the client seeks someone who can maintain comprehensive testing records, generate detailed reports, and provide clear communication to stakeholders. Your ability to document test results and provide actionable insights is vital for ensuring regulatory compliance and informing future development.

FAQs About the Role – Orthotic Device Testing and Validation Engineer – Omaha, NE

1. What are the key responsibilities of the Orthotic Device Testing and Validation Engineer in this role?

As an Orthotic Device Testing and Validation Engineer, you will be responsible for testing and validating orthotic devices to ensure they meet performance, safety, and regulatory standards. You will develop test plans, execute performance evaluations, and provide technical recommendations for improvements. Your role will involve cross-functional collaboration with design and manufacturing teams to enhance product quality and reliability, while ensuring compliance with industry regulations.

2. What qualifications and experience are required for this position?

The ideal candidate should have a degree in engineering, biomedical sciences, or a related field. Experience in testing and validating medical devices, specifically in the orthotics or healthcare sector, is highly preferred. Familiarity with regulatory standards such as FDA and ISO is essential. Experience with mechanical testing, data analysis, and risk management will be crucial for success in this role.

3. What technical skills are important for this role?

Strong proficiency in testing methodologies, mechanical testing equipment, and data analysis tools is essential. You should have experience with statistical analysis, technical documentation, and the ability to identify design flaws or opportunities for improvement. Familiarity with quality control systems, risk assessment, and regulatory compliance in medical device testing will be key to performing well in this role.

4. What challenges can I expect in this role?

In this role, you can expect challenges such as managing complex testing processes, troubleshooting device issues, and ensuring compliance with stringent regulatory standards. You will need to work effectively with cross-functional teams to resolve technical problems and address any issues that arise during the testing and validation phases. Adapting to new technologies and staying updated with industry trends will also be an ongoing challenge.

5. What is the expected impact of the Orthotic Device Testing and Validation Engineer on the company’s success?

The Orthotic Device Testing and Validation Engineer plays a critical role in ensuring the safety, functionality, and regulatory compliance of orthotic devices. Your work directly impacts the quality of the products that reach the market, ensuring patient safety and satisfaction. By maintaining rigorous testing standards, you will help position the company as a trusted leader in the orthotic device industry.

6. What is the company’s culture and work environment like?

The company fosters a collaborative and innovative work environment where team members are encouraged to share ideas and contribute to problem-solving. A commitment to quality, continuous improvement, and patient safety is at the core of the company’s culture. You will be part of a dynamic, fast-paced team that values attention to detail and strives to make a positive impact on healthcare through technology and product development.

What Remuneration Can You Expect from This Job?

As the Orthotic Device Testing and Validation Engineer in Omaha, NE, you can expect a competitive and comprehensive compensation package tailored to attract highly qualified professionals in the medical device field. The remuneration for this role typically includes the following elements:

1. Base Salary

The base salary for an Orthotic Device Testing and Validation Engineer varies depending on experience, qualifications, and the company’s size. In this role, the annual base salary typically ranges from $70,000 to $100,000, with higher salaries possible for candidates with significant experience in the medical device or orthotics field.

2. Performance-Based Bonuses

In addition to the base salary, many companies offer annual performance-based bonuses. These bonuses are typically tied to key performance indicators (KPIs) such as product quality, testing efficiency, compliance with regulatory standards, and team collaboration. Bonus amounts can range from 5% to 15% of the base salary, depending on individual and company performance.

3. Stock Options & Equity-Based Incentives

For some positions, especially within larger companies or those experiencing significant growth, stock options or equity-based incentives such as restricted stock units (RSUs) may be offered. These incentives are designed to align employee compensation with the long-term success of the company. The value of these stock options can vary, but they can provide a significant long-term financial benefit.

4. Health & Wellness Benefits

A comprehensive benefits package is typically offered, including:

• Health, dental, and vision insurance
• 401(k) or retirement savings plans with company contributions
• Life insurance and disability coverage
• Employee wellness programs to support physical and mental health

These benefits help ensure your well-being and financial security.

5. Professional Development & Continuing Education

Many companies encourage employees to continue their education and professional development. As an Orthotic Device Testing and Validation Engineer, you may receive financial assistance or coverage for certifications, training, or conferences related to orthotics, biomedical engineering, or medical device testing.

6. Relocation Assistance

If applicable, the company may offer relocation assistance to help with moving expenses and settling into Omaha, NE. This can include reimbursement for moving costs, temporary housing, and other expenses associated with relocation.

Total Compensation Potential

When factoring in base salary, bonuses, benefits, and potential stock options, total compensation for an Orthotic Device Testing and Validation Engineer can range from $75,000 to $120,000 or more annually, depending on experience, company size, and the specific compensation package offered by the employer.

How to Apply

If you are an experienced Orthotic Device Testing and Validation Engineer with a passion for improving medical technology, we invite you to apply for this exciting opportunity in Omaha, NE. As part of a forward-thinking company in the orthotic device industry, you will play a crucial role in testing, validating, and ensuring the highest quality standards for innovative orthotic products.

To apply, please submit your resume and a cover letter that highlights your experience in medical device testing, quality assurance, and validation within the orthotic or healthcare device industry. Detail your proficiency in testing protocols, regulatory compliance, and your ability to work collaboratively with cross-functional teams. We are particularly interested in your experience with orthotic devices, testing methodologies, and any certifications or qualifications relevant to this field.

This is a fantastic opportunity to contribute to the development and validation of cutting-edge medical technology while advancing your career in a growing industry. Apply today and take the next step in your career as an Orthotic Device Testing and Validation Engineer in Omaha, NE!

For more information or to explore similar opportunities, visit our Medical Device Careers Page.

Tags:
Orthotic Device Testing | Medical Device Engineer Jobs | Validation Engineer | Quality Assurance | Regulatory Compliance | Healthcare Engineering | Testing Protocols | Device Validation | Orthotic Products