Actalent
Website:
bit.ly
Company:
https://www.linkedin.com/company/actalentservices
Seniority: Not Applicable
Industries: Business Consulting and Services
Job details:
Job Title: R&D Engineer – Class IIb/III Medical Devices
Job Description
This role focuses on leading and supporting design and remediation activities for Class IIb and Class III medical devices, ensuring full alignment with FDA and ISO requirements and IEC medical electrical equipment safety standards. The R&D Engineer uses SolidWorks and Windchill to develop and refine designs, conducts engineering studies and validation testing, and generates comprehensive technical documentation that supports regulatory compliance and robust design controls.
Responsibilities
- Lead and support remediation design activities for Class IIb and Class III medical devices in accordance with FDA regulations and ISO standards.
- Apply IEC medical electrical equipment safety requirements throughout the design and development process.
- Use SolidWorks to create, modify, and optimize 3D models and engineering drawings for medical device components and assemblies.
- Utilize Windchill for product lifecycle management, including version control, document management, and configuration management.
- Conduct engineering studies and technical evaluations to assess design performance, reliability, and safety.
- Plan and execute testing activities, including test method validation, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure design controls are fully aligned with applicable regulatory and quality system requirements.
- Generate technical documentation such as design inputs and outputs, risk analyses, verification and validation protocols, and test reports.
- Collaborate with cross-functional teams to resolve design issues, implement improvements, and support regulatory submissions.
- Maintain accurate records and documentation to demonstrate compliance with internal procedures and external regulatory standards.
Essential Skills
- 3 to 8 years of experience in R&D engineering for medical devices, preferably Class IIb or Class III.
- Hands-on experience with SolidWorks for 3D modeling and engineering design.
- Experience using Windchill or similar product lifecycle management (PLM) tools.
- Proven experience working with Class IIb or Class III medical devices.
- Strong understanding of IEC medical electrical equipment safety requirements.
- Demonstrated ability to lead and support remediation design activities in accordance with FDA regulations and ISO standards.
- Experience conducting engineering studies, test method validation, IQ, OQ, and PQ activities.
- Ability to generate comprehensive technical documentation, including design inputs and outputs, risk analyses, verification and validation protocols, and test reports.
- Solid knowledge of design controls and regulatory requirements for medical devices.
Additional Skills & Qualifications
- Experience in medical device R&D with exposure to regulatory and quality systems.
- Strong analytical and problem-solving skills for evaluating design risks and performance.
- Attention to detail in preparing and reviewing technical documentation.
- Effective communication skills for collaborating with cross-functional teams and presenting technical findings.
- Ability to work independently while managing multiple projects and deadlines.
Work Environment
The role is based in a medical device R&D setting that emphasizes regulatory compliance, quality, and patient safety. You will work with modern engineering tools such as SolidWorks for design and Windchill for product lifecycle management, and participate in structured testing and validation activities including IQ, OQ, and PQ. The environment is collaborative and documentation-driven, with a strong focus on design controls, technical reporting, and adherence to FDA, ISO, and IEC standards.
Diversity, Equity & Inclusion
At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Is Embedded Into Our Culture Through
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
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