ALKU
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)
#J-18808-Ljbffr
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)
#J-18808-Ljbffr