R&D Engineer
Position Summary
We are seeking an experienced Senior R&D Engineer to support the development and commercialization of innovative medical device products. This individual will play a key role in product development activities from concept through design transfer, collaborating with cross-functional teams to develop robust products and processes that meet customer, business, and regulatory requirements.
The ideal candidate will possess approximately 10-12 years of engineering experience within the medical device industry, with a track record of leading technical projects, solving complex engineering challenges, and supporting product development in a regulated environment.
Key Responsibilities
- Lead product development activities throughout the design and development lifecycle.
- Develop engineering solutions to support new product development and continuous product improvement initiatives.
- Generate design concepts, test plans, technical documentation, and engineering analyses.
- Collaborate with Quality, Manufacturing, Regulatory Affairs, Clinical, and Operations teams to ensure successful project execution.
- Support risk management activities, including design reviews and product risk assessments.
- Plan and execute verification and validation testing to ensure product performance requirements are met.
- Analyze engineering, product, and test data to support design decisions and recommendations.
- Participate in design transfer activities and support manufacturing readiness efforts.
- Investigate and resolve technical issues through structured problem-solving methodologies.
- Contribute to project planning, technical decision-making, and cross-functional team discussions.
- Ensure compliance with applicable quality systems, design control requirements, and regulatory standards.
- Mentor junior engineers and provide technical guidance across project teams.
Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related engineering discipline.
- Approximately 10-12 years of engineering experience, preferably within the medical device, biotechnology, or other regulated product industries.
- Experience supporting product development activities from concept through commercialization.
- Knowledge of design control processes, verification and validation, and risk management principles.
- Experience working in a regulated environment governed by FDA, ISO 13485, or similar standards.
- Strong technical problem-solving, analytical, and troubleshooting skills.
- Demonstrated ability to lead complex projects and influence cross-functional teams.
- Excellent written, verbal, and interpersonal communication skills.
Preferred Experience
- Class II or Class III medical device development experience.
- Experience with design verification, validation, and statistical data analysis.
- Familiarity with materials, manufacturing processes, or device testing methodologies.
- Participation in design reviews, product risk assessments, and technical documentation development.
- Experience supporting product launches, design transfers, or sustaining engineering initiatives.
FAQs
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