Saluda Medical
Senior Mechanical Engineer (Biocompatibility, Packaging, and Sterilization)
Minnetonka, Minnesota · Senior
Sponsorship not specifiedDetected 41 days ago
Product ManagementMechanical DesignFDA RegulatoryMedical DevicesLeadershipCommunicationCollaboration
About the role
- 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.
- Author and approve Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), toxicological assessments, and supporting documentation.
Responsibilities
- Provide SME guidance during design controls, material selection, process development, and change control.
- Coordinate and technically manage external laboratories performing biocompatibility and microbiological testing.
- Develop and maintain sterilization strategies for implantable devices, including EO, gamma, or other validated modalities.
- Partner with manufacturing to ensure sterilization processes remain compliant, robust, and audit ‑ ready.
- Lead packaging material selection, sterile barrier system development, and packaging design improvements.
- Support packaging validation, including seal integrity, transit testing, and aging studies.
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.
- Collaborative, team ‑ oriented mindset with the ability to work across global functions.
Nice to have
- Working knowledge of FDA, EU MDR, ISO 10993, ISO 11135/11137, ISO 11607, and related standards.
- Prior experience with chemical characterization, toxicology, or sterilization validation.
- We believe people are the source of our inspiration and innovation.
- Preferred Experience:
Skills
- Biocompatibility & Biological Safety
- Oversee chemical characterization, extractables/ leachable assessments, and toxicological risk evaluations.
- Sterilization of Medical Devices
- Evaluate sterilization residues, cleaning processes, and microbiological considerations to ensure patient safety.
- Support sterilization validation activities, documentation, and regulatory submissions.
- Packaging Development
Benefits
- Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform.
- Saluda Medical is headquartered in Minneapolis, Minnesota.
Company info
- At Saluda, we challenge boundaries.
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