About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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About the Role

Confidential Client (Scientific & QA) is hiring an entry-level Design Assurance Engineer I to join the Design Assurance team in Clarence, NY. This role supports design verification, design validation, test method development, risk management (ISO 14971), and related quality activities for medical device products. This is a full-time, on-site position based in Clarence, NY.

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What You’ll Do

You will work under the direction of experienced Design Assurance mentors and contribute to the product development lifecycle by supporting verification, validation, and quality activities. Typical responsibilities include:

• Assist with development and validation of test methods, fixtures, and tooling
• Execute product and process testing to support design and process validation
• Perform statistical analyses (e.g., gage R&R) using tools like Minitab
• Support risk management activities per ISO 14971
• Draft and update test method procedures and design assurance SOPs
• Participate on cross-functional project teams (R&D / NPI) to ensure compliance with the product development process (PDP)
• Contribute technical input to investigations, root-cause analysis, and corrective actions
• Periodically review internal and external standards and identify gaps
• Support Manufacturing Excellence and continuous improvement initiatives

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Qualifications & Skills

• Bachelor’s degree in Engineering, Quality, or a related technical field
• 0–3 years of relevant experience (entry-level candidates encouraged)
• Working knowledge of statistics and experience with Minitab or similar tools
• Familiarity with design verification & validation concepts and test method development
• Understanding of risk management principles (ISO 14971) is strongly preferred
• Strong written and oral communication skills
• Demonstrated ability to collaborate on cross-functional teams and work independently with guidance
• Positive, safety-conscious attitude with a focus on quality

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Compensation & Benefits

• Base salary range: $58,800 — $85,800 per year (posted range)
• Total rewards include eligibility for cash-based incentive programs, medical/dental/vision, disability, life insurance, 401(k) with company match, paid time off, company-designated holidays, and other voluntary benefits. Parental leave eligibility after one year.
• Note: This salary range is provided in compliance with applicable pay transparency requirements.

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How You’ll Be Measured

• Contribution to site Quality KPIs and safety programs
• Achievement of defined goals and project milestones
• Quality of technical deliverables (test methods, reports, investigations)
• Participation in innovation and continuous improvement
• Adherence to Confidential Client values and Quality Management System requirements

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.