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Medical Device Operations Jobs (NOW HIRING)

Medical Device Quality Inspector Location: Madison, WI (Onsite) Pay Rate: $30/hr. on W2 Job Summary ... operations. The ideal candidate is detail-oriented , computer-proficient , and eager to learn ...

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Job Title Medical Device Service Engineer Requisition JR000015824 Medical Device Service Engineer ... operational capabilities. Responsible for training and support of other Service personnel that ...

This position includes comprehensive assembly and operation of various equipment and machinery ... Prior experience in a medical device manufacturing setting is required. * Embody the AVI Guiding ...

Medical Device Operator II Temecula CA 92591 12 MONTHS Start Time 5am to 6am End Time1:30pm to 2 ... Ensure that relevant job documentation for cell operations and functions is accurate and up to date.

This position includes comprehensive assembly and operation of various equipment and machinery ... Prior experience in a medical device manufacturing setting is required. * Embody the AVI Guiding ...

... and operational efficiency. • 7+ years of recruiting experience, with strong expertise in full ... in the medical device industry is strongly preferred. • Demonstrated success sourcing and ...

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Medical Device Operations information

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How much do medical device operations jobs pay per hour?

As of Jul 3, 2026, the average hourly pay for medical device operations in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 per hour, depending on experience, location, and employer.

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are some common challenges faced by professionals in Medical Device Operations, and how can they be addressed?

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What are medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in Medical Device Operations, and why are they important?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.
More about Medical Device Operations jobs
What cities are hiring for Medical Device Operations jobs? Cities with the most Medical Device Operations job openings:
What are the most commonly searched types of Medical Device Operations jobs? The most popular types of Medical Device Operations jobs are:
What states have the most Medical Device Operations jobs? States with the most job openings for Medical Device Operations jobs include:
Infographic showing various Medical Device Operations job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 89% Full Time, 1% Part Time, and 9% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $54,588 per year, or $26.2 per hour.
Medical Device Manufacturing Engineer

Medical Device Manufacturing Engineer

PMC Smart Solutions LLC

Shelbyville, IN • On-site

$69K - $89K/yr

Full-time

Posted 15 days ago


PMC Smart Solutions rating

5.8

Company rating: 5.8 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

68th of 79 rated plastic manufacturers


Job description

Job Type
Full-time
Description
  • Do you enjoy building and optimizing manufacturing processes that support high-quality medical device production?
  • Are you energized by solving engineering challenges while developing innovative manufacturing solutions that improve efficiency and quality?
  • Are you looking to join a growing team in the medical manufacturing industry where innovation, collaboration, and continuous improvement directly impact products that save lives?

If yes, PMC SMART Solutions is the place for you!
Who is PMC SMART Solutions?
PMC, as a globally-recognized, award-winning contract manufacturer, provides life-saving medical devices and safety-enhancing automotive components to a broad base of international, market-leading OEMs and Tier One customers.
PMC offers services from design for manufacturability and program management through injection molding, full assembly, packaging and sterilization management, focusing on precise-tolerance, intricate devices and components. For its medical customers, PMC functions under ISO 13485 certification, FDA registration and operates state-of-the-art, certified Class 8 (100,000) clean rooms.
PMC is a certified Women-Owned Business Enterprise, offering a comprehensive range of services while supporting global OEMs' supplier diversity goals.
What would you look forward to in this role?
  • Developing and optimizing manufacturing processes that ensure efficient, high-quality, and cost-effective production of medical devices.
  • Designing tooling, fixtures, and manufacturing workflows that improve production accuracy, repeatability, and operational efficiency.
  • Leading engineering activities that support successful new product launches from development through full production readiness.
  • Partnering cross-functionally with Quality, Operations, customers, and Engineering teams to solve technical challenges and drive project success.
  • Supporting validation activities and regulatory compliance efforts that ensure manufacturing processes meet strict medical industry standards.
  • Playing a critical role in manufacturing products that directly support life-saving medical applications.

What key responsibilities would you assume in this role?
Device Building & Process Optimization
  • Develop and implement manufacturing processes supporting medical device production, including molding, machining, assembly, and post-processing operations.
  • Design and implement custom assembly fixtures, inspection tooling, and manufacturing solutions that improve production accuracy and efficiency.
  • Optimize production workflows to reduce cycle times, improve product yield, and lower overall manufacturing costs.
  • Analyze production data to identify process improvement opportunities and support cost reduction initiatives.
  • Troubleshoot manufacturing challenges, identify root causes, and implement corrective actions that improve operational performance.
  • Support Lean Manufacturing initiatives focused on improving efficiency, reducing waste, and increasing throughput.
  • Evaluate manufacturability of customer device designs to ensure production readiness and efficient manufacturing execution.
  • Provide technical feedback during design reviews to improve manufacturability, assembly performance, and product quality.

Project Launch Support
  • Lead engineering activities supporting projects from initial development through successful product launch and production readiness.
  • Coordinate cross-functional teams including Quality, Operations, customers, and internal stakeholders to align project deliverables and timelines.
  • Facilitate technical meetings that drive project alignment, resolve challenges, and maintain momentum toward successful launch milestones.
  • Support Sales and business development efforts by assisting with cost estimates, manufacturing quotes, and lead time projections for customer proposals.
  • Partner with internal teams to ensure manufacturing readiness before transitioning products into production.

Quality & Validation
  • Develop and execute validation protocols supporting equipment, manufacturing processes, and test methods.
  • Perform validation activities including Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure manufacturing processes comply with FDA regulations and applicable medical device industry standards.
  • Support preparation and maintenance of documentation required for customer regulatory submissions and internal quality systems.
  • Collaborate with Quality and Engineering teams to ensure validated manufacturing processes remain scalable, repeatable, and audit-ready.
  • Support ongoing compliance initiatives that reinforce PMC's commitment to quality, safety, and regulatory excellence.

Who will you work side by side to achieve extraordinary results?
  • Quality, Operations, and Engineering teams focused on successful product development and production execution
  • Cross-functional teams supporting new product launches and manufacturing readiness
  • Customers and project stakeholders collaborating on medical device development and production requirements
  • Internal leadership teams focused on innovation, quality, and operational excellence
  • Manufacturing teams committed to producing life-saving products with precision and consistency

Requirements
What is needed to thrive in this role?
  • Strong manufacturing engineering experience supporting process development, production optimization, and product launch activities.
  • Experience developing manufacturing processes involving molding, machining, assembly, and post-processing operations.
  • Experience designing tooling, fixtures, and manufacturing systems that improve efficiency and product quality.
  • Strong troubleshooting and root cause analysis skills with the ability to solve technical manufacturing challenges quickly and effectively.
  • Experience supporting validation activities including IQ, OQ, PQ, and Test Method Validation (TMV).
  • Familiarity with FDA regulations, medical device manufacturing requirements, and regulated quality systems.
  • Experience supporting new product launches and managing engineering deliverables from development through production.
  • Strong project management and cross-functional collaboration skills with the ability to manage multiple priorities simultaneously.
  • Experience with Lean Manufacturing, process improvement methodologies, and continuous improvement initiatives.
  • Strong communication skills and the ability to work effectively with customers, internal stakeholders, and cross-functional teams.
  • A proactive mindset focused on innovation, quality, accountability, and PMC's mission of manufacturing products that save lives.

What PMC Smart Solutions employees say

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