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Contract Quality Engineer Medical Device Jobs (NOW HIRING)

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

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Contract Quality Engineer Medical Device information

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How much do contract quality engineer medical device jobs pay per year?

As of Jun 9, 2026, the average yearly pay for contract quality engineer medical device in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What is the difference between Contract Quality Engineer Medical Device vs Contract Quality Engineer Pharmaceutical?

AspectContract Quality Engineer Medical DeviceContract Quality Engineer Pharmaceutical
CertificationsISO 13485, FDA QSR, GMPICH Q7, GMP, FDA regulations
Work EnvironmentMedical device manufacturing, labs, compliance auditsPharmaceutical production, labs, quality assurance
Industry UsageMedical device companies, OEMs, suppliersPharmaceutical firms, biotech companies, contract manufacturers

Both roles focus on quality assurance and regulatory compliance but differ mainly in industry-specific standards and environments. Contract Quality Engineers Medical Device work primarily with ISO 13485 and FDA QSR standards in device manufacturing, while Contract Quality Engineers Pharmaceutical focus on GMP and ICH Q7 regulations in drug production. Understanding these differences helps candidates target the right industry and certifications for their career goals.

What does a Contract Quality Engineer do in the medical device industry?

A Contract Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory and company quality standards during a specific project or timeframe. They typically work on a contract basis, focusing on tasks like process validation, risk management, root cause analysis, and compliance with standards such as ISO 13485 and FDA regulations. Their role often involves collaborating with engineering, production, and regulatory teams to troubleshoot quality issues and implement corrective actions. They play a key role in maintaining product safety and regulatory compliance throughout the manufacturing process.

What are the key skills and qualifications needed to thrive as a Contract Quality Engineer in the Medical Device industry, and why are they important?

To thrive as a Contract Quality Engineer in the Medical Device field, you need expertise in quality assurance, regulatory compliance (such as ISO 13485 and FDA regulations), and a background in engineering or life sciences. Familiarity with tools like CAPA systems, risk management software, and proficiency in quality management systems (QMS) is typically required. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills are essential to ensure product safety, regulatory compliance, and the successful launch and maintenance of medical devices in a highly regulated environment.

How does a Contract Quality Engineer in the medical device industry typically collaborate with cross-functional teams?

As a Contract Quality Engineer in the medical device sector, you will frequently work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain. Your responsibilities often involve reviewing design documentation, participating in risk assessments, and ensuring production processes meet both internal quality standards and regulatory requirements. Effective communication is key, as you'll be responsible for conveying quality expectations, addressing non-conformities, and supporting project timelines. This collaborative environment provides valuable experience in coordinating with diverse professionals while upholding strict industry standards.
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What cities are hiring for Contract Quality Engineer Medical Device jobs? Cities with the most Contract Quality Engineer Medical Device job openings:
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Contract Quality Engineer Medical Device jobs near you
Infographic showing various Contract Quality Engineer Medical Device job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Senior Mechanical Engineer - Medical Device

Micro Leads Inc

Somerville, MA • On-site

$80K - $100K/yr

Full-time

Medical, Dental, Life

Posted 10 days ago

Job description

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

Company Description

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.