Staff Compliance Engineer - Test and Certification
Stryker · Kayseri
Work Flexibility: Hybrid or OnsiteAs a Staff Compliance Engineer - Test and Certification, you will play a key technical role in New Product Development (NPD), supporting products from the conceptual design stage through testing, certification, and product launch. You will work on international projects, collaborating with engineering and cross-functional teams across multiple countries and cultures.
This is a strong opportunity to build expertise in product safety, compliance, testing, and certification while gaining broad exposure to the full product development lifecycle. You will work closely with Electrical, Mechanical, Software, Quality, and Test Engineering teams, as well as external laboratories, certification bodies, and international stakeholders.
The role offers significant growth and learning opportunities, with access to local and international technical experts and trainers, enabling you to develop both your technical expertise and experience working in a global NPD environment.
What will you do:
- Lead product safety, compliance, and certification activities for new product development and product sustainment projects.
- Develop and execute safety and performance test plans, including electrical safety, EMC, environmental, and recurring safety testing.
- Partner with Electrical, Mechanical, Software, Quality, and Test Engineering teams to identify and resolve compliance and product safety risks.
- Lead technical design reviews, risk assessments, failure analysis, and investigations of test failures or recurring safety issues.
- Coordinate testing and certification activities with third-party laboratories, certification bodies, suppliers, and contractors.
- Analyse test data and product failures to identify root causes and provide recommendations for design and product improvements.
- Support regulatory and certification audits by providing technical expertise, documentation, and responses to compliance-related findings.
- Act as the technical point of contact for product compliance and safety, ensuring successful certification and continued compliance throughout the product lifecycle.
What will you need:
Required:
- Bachelor’s degree in Electrical Engineering or related discipline.
- 5+ years of experience in electrical engineering, product safety, compliance, testing, or certification.
- Working knowledge of Mechanical Engineering principles, including environmental, vibration/shock, thermal, and mechanical safety testing.
- Strong knowledge of electrical safety, product performance, EMC, and laboratory testing.
- Experience with electrical laboratory equipment such as oscilloscopes, signal generators, and power analysers.
- General proficiency in English, written and spoken.
Preferred:
- Experience in medical device development, testing, or certification.
- Working knowledge or certification in IEC 60601-1 and IEC 60601-1-2.
- Knowledge of ISO 14971 risk management.
- Knowledge of ISO 13485 and/or ISO 9001 quality systems.
- Experience working with certification bodies, regulatory agencies, or accredited test laboratories.
Please note that the Internal Business Job Title may differ from the Posting Title. The Internal Business Job Title for this role is Staff Compliance Engineer.
Travel Percentage: 10%