Senior Research & Development Engineer (Medical Device R&D)
X4 Life Sciences are partnered with an innovative medical device organization that is transforming patient care through cutting-edge solutions. With FDA-cleared products, this company is setting new industry standards in healthcare, and they are seeking a Senior Research & Development Engineer to join their team.
About the Role
This role focuses on designing, testing, and documenting new products and production processes, contributing directly to impactful healthcare advancements. As a Senior R&D Engineer, you will:
- Lead Product Development: Design and test new product concepts aligned with FDA design control requirements, from prototype to final product.
- Document and Support: Prepare design and specification documentation to support regulatory submissions.
- Maintain Lab Standards: Oversee lab organization, equipment maintenance, and safety protocols.
- Ensure Quality Compliance: Contribute to Quality Management System compliance with ISO 13485 and 21 CFR Part 820.
- Drive Collaboration and Innovation: Support design verification, validation, and production documentation efforts, ensuring quality and efficiency.
- Vendor and Material Assessment: Identify and evaluate raw materials and vendors relevant to product development.
Ideal Candidate Profile:
- 3+ years of R&D and production experience within the medical device industry.
- Strong knowledge of FDA 820.75, ISO 13485, GLP, and GMP standards.
- A Bachelor’s degree in Chemistry, Life Sciences, Biomedical Engineering, or related field.
Apply Now
Please apply directly, and/or email directly at o.archer@x4lifesciences.com.
