Senior Biocompatibility Engineer - Implantable Devices

Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of advanced AI, real-time diagnostics, and ground-breaking clinical evidence.  Every day at Saluda, we are focused on the dignity of responsibility to elevate human health and optimize clinician operations by unlocking the power of data and science to reach patients in need.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain. 

Saluda Medical is seeking a Senior Biocompatibility Engineer to lead strategic material and process selections. This role is crucial for ensuring our products meet rigorous biocompatibility standards across global markets. The Specialist will collaborate with diverse teams, from R&D to manufacturing, to support and impact our product lifecycle.

Essential Functions:

Regulatory Compliance: Ensure adherence to US and global regulations (EU, China, Korea, Japan) and standards such as ISO 10993 and ISO 18562.

Material and Process Evaluation: Assess materials and processes for biocompatibility, including sterile packaging and reliability testing.

Risk Management and Testing: Conduct risk assessments, develop test systems, and execute biocompatibility testing to mitigate potential issues.

Key Responsibilities:

• Conduct scientific risk assessments for design control.

• Design and implement biocompatibility testing procedures.

• Evaluate materials for research and development purposes.

• Solve biomaterials and biocompatibility challenges.

• Oversee a portfolio of product development projects.

• Support global regulatory submissions.

• Assess manufacturing and supplier changes for biocompatibility.

• Communicate effectively with stakeholders.

• Ensure testing procedures meet international standards.

• Manage biocompatibility assessment documents.

Qualifications:

• Bachelor's/Master's degree in relevant fields with 5+ years of biocompatibility experience, or PhD in a related discipline.

• Proficiency in relevant standards such as ISO 13485, ISO 14971, and 21 CFR part 820.

• Strong verbal and written communication skills for regulatory submissions.

• Experience in R&D related to materials and biocompatibility.

• Ability to work independently and collaboratively in a team environment.

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation