Senior Mechanical Engineer - Medical Device

Location: Somerville, MA

Senior Mechanical Engineer – Medical Device

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 design electrodes for stimulation and nerve recordings. In addition, the candidate will prototype, build, and conduct mechanical integrity and related tests. The individual will also develop manufacturing processes and work with vendors to manufacture components.

The candidate must have significant background in medical device development, implantable electrodes, process development, and verification and validation. 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
• End-to-end development of assembly and manufacturing processes
• 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 Mechanical or Biomedical Engineering, M.S. Preferred
• 2-4 years of related professional experience post-Bachelor’s Degree

Desired qualifications & 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.

Benefits:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Stock Options