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ALKU

Mechanical Design Engineer

ALKU, Houston, Texas, United States, 77246

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Overview We are seeking a highly experienced Mechanical Design Engineer with a deep technical background in the design and development of implantable neurostimulation leads for active implantable medical devices. The ideal candidate has over 10 years of hands-on experience driving innovative solutions across spinal cord, brain, and peripheral nerve stimulation therapies. The candidate should have extensive experience working with SolidWorks.

Responsibilities

Drive end-to-end development of implantable neurostimulation leads, from concept through commercialization.

Drive design efforts including materials selection, electrical and mechanical layout, manufacturability, and biocompatibility.

Collaborate cross-functionally with systems engineering, regulatory, quality, and manufacturing teams.

Support design verification/validation (DV/DT), pre-clinical testing, and design transfer to manufacturing.

Ensure compliance with ISO 13485, IEC 60601, and FDA Class III device regulations.

Qualifications

10+ years of experience in medical device R&D, including implantable neurostimulation systems.

SolidWorks experience 5+ years

Proven track record in development of leads for spinal cord, brain (DBS), or peripheral nerve stimulation.

Expertise in biocompatible materials, electrical interfaces, and active implant assembly processes.

Familiarity with risk management (ISO 14971), DFMEA, and design controls.

Seniority level Mid-Senior level

Employment type Contract

Job function

Engineering, Manufacturing, and Production

Industries

Medical Equipment Manufacturing and Biotechnology Research

Benefits

Medical insurance

Vision insurance

401(k)

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