Senior Mechanical Engineer (Biocompatibility, Packaging, and Sterilization)

About 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.

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.
  • Coverage of 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 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.
  • Contribute to engineering specifications, drawings, and verification activities.
  • Provide technical leadership for issue investigations, including root-cause analysis, documentation, and corrective actions.

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.