Job description

Overview:

Micro-Leads is a fast-paced early-stage company developing an injectable medical device to treat people with chronic pain with greater efficacy. Our company has extensive expertise in precision implantable medical devices for nerve stimulation and neuromodulation.

Role Summary:

The primary role of this position is to design and build injectable electrodes for needle delivery and implantable pulse generator housings for next-generation neurostimulator devices. The individual will develop materials and plastic processes to develop injectable self-opening electrodes for stimulation and nerve recordings. In addition, the candidate will prototype, build, and conduct adhesion and biomechanical tests. The individual will also develop novel processes and work with vendors to manufacture components.

The candidate must have significant background in plastics processing, micro molding, mold design, and lamination. The individual should be hands-on and have direct experience working with vendors and design transfer to contract manufacturers.

Responsibilities:

• Mechanical design of implantable electrodes for neuromodulation from plastics and polymers
• End-to-end development of electrode design, molding, assembly
• Design of processes for thin substrate laminations and bonding techniques
• Design of microscale assembly techniques, including scaling to manufacturability
• Develop micro-molding, thermoforming, and lamination methods for thin substrates and catheters
• Create 3D assemblies and technical drawings of electrodes and implantable housings using SolidWorks and AutoCAD
• Identify, source, and manage vendors to obtain hardware components on a schedule (e.g. procuring materials, services from machine shops or 3D printing houses, contract manufacturing)
• Develop mechanical testing structures and set up accelerated lifetime tests
• Manage engineering personnel as necessary (e.g. junior engineers, technicians, co-ops)
• Adhere to Micro-Leads quality management system, understands essential regulatory requirements, and follows standard operating procedures
• Maintain design control requirements related Micro-Leads’ QMS including developing design inputs/outputs, risk management, verification and validation

Minimum qualifications:

• B.S. in Plastics Engineering, Mechanical Engineering, or Biomedical Engineering, M.S. Preferred
• 2-4 years of related professional experience post-Bachelor’s Degree

Desired qualifications & experience:

• M.S. degree in Mechanical or Plastics Engineering or equivalent experience
• Successful candidates must be able to multi-task and work effectively as part of a small team
• Successful candidates will have excellent benchtop capability including the dexterity to manipulate small structures under a stereomicroscope
• Familiarity with standard tooling for rapid prototyping (e.g. drill presses, saws, welding, soldering, CNC mills)
• Experience with precision microscale assembly of silicone electrodes using processes such as injection molding, casting, micro-fluidic molding, etc.
• Experience with Class III implantable systems and hermetic manufacturing methods
• Experience with precision microscale assembly of silicone electrodes using processes such as injection molding, thermoforming, lamination, micro-molding, etc.
• Strong mechanical design skills and are proficient in AutoCAD and SolidWorks
• Strong understanding of metal and polymer properties (e.g. fatigue, failure analysis, biocompatibility)
• Understands electrode charge injection and impedance
• Understands reliability testing standards
• Familiarity with standard compliance such as 21 CFR 820, ISO 13485, ISO 14708, ISO 14971
• Familiarity with programming (e.g. MATLAB, Python)

Benefits:

• Medical Insurance
• Dental Insurance
• Stock Options

Job Type: Full-time

Pay: $84,506.00 - $92,817.00 per year

Benefits:

• Dental insurance
• Health insurance
• Health savings account
• Paid time off

Schedule:

• Monday to Friday

COVID-19 considerations:
We follow all CDC guidelines.

Ability to commute/relocate:

• Somerville, MA 02144: Reliably commute or planning to relocate before starting work (Required)

Experience:

• mechanical design: 6 years (Required)

Work Location: One location

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