The Role: The Sr. Mechanical Engineer is a key technical leader within the US-based New Product Development team. Reporting to the Head of ME, this role provides end-to-end ownership of biological safety, materials evaluation, sterilization strategy, and packaging development across the full product lifecycle. This position partners closely with R&D, Quality, Regulatory, Manufacturing, and external test laboratories to ensure Saluda's implantable devices meet global regulatory expectations, including FDA and EU MDR. The role also supports investigations, materials assessments, and the development of new mechanical designs and manufacturing methods. Essential Functions & Duties: Biocompatibility & Biological Safety • Lead biological safety strategy for all patient-contacting components in accordance with ISO 10993, ISO 14971, FDA guidance, and EU MDR. • Author and approve Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), toxicological assessments, and supporting documentation. • Oversee chemical characterization, extractables/leachable assessments, and toxicological risk evaluations. • Provide SME guidance during design controls, material selection, process development, and change control. • Coordinate and technically manage external laboratories performing biocompatibility and microbiological testing. Sterilization of Medical Devices • Develop and maintain sterilization strategies for implantable devices, including EO, gamma, or other validated modalities. • Evaluate sterilization residues, cleaning processes, and microbiological considerations to ensure patient safety. • Support sterilization validation activities, documentation, and regulatory submissions. • Partner with manufacturing to ensure sterilization processes remain compliant, robust, and audit-ready. Packaging Development • Lead packaging material selection, sterile barrier system development, and packaging design improvements. • Support packaging validation, including seal integrity, transit testing, and aging studies. • Ensure packaging solutions meet ISO 11607 and global regulatory requirements. • Collaborate with suppliers and internal teams to resolve packaging-related issues and drive continuous improvement. Materials Science & Mechanical Engineering Support • Conduct materials assessments, including evaluation of polymers, metals, adhesives, coatings, and surface treatments. • Lead feasibility studies for new materials, processes, and manufacturing technologies supporting next-generation products. • Support mechanical design development and contribute to engineering specifications, drawings, and verification activities. • Provide technical leadership for issue investigations, including root-cause analysis, documentation, and corrective actions. Cross-Functional Collaboration & Regulatory Support • Work closely with R&D, Quality, Regulatory, Clinical, and Manufacturing teams to ensure alignment across programs. • Provide expert input for global regulatory submissions, audits, inspections, and CAPA activities. • Ensure all documentation is complete, traceable, and compliant with Saluda's quality system. Essential Requirements: • Bachelor's degree or higher in Materials Science, Mechanical Engineering, Biomedical Engineering, or related field. • Strong understanding of biocompatibility, sterilization, materials science, and packaging principles. • Excellent written and verbal communication skills, with the ability to convey complex technical information clearly. • Demonstrated problem-solving ability and experience conducting detailed engineering investigations. • Experience working within a QA-controlled, regulated medical device environment. • Collaborative, team-oriented mindset with the ability to work across global functions. Preferred Experience: • Working knowledge of FDA, EU MDR, ISO 10993, ISO 11135/11137, ISO 11607, and related standards. • Experience in neuromodulation, implantable devices, or active medical systems. • Prior experience with chemical characterization, toxicology, or sterilization validation.