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Medical Device Operations Jobs in Ohio (NOW HIRING)

Norwood Medical

Supply Chain Director

Dayton, OH · On-site

$176K - $200K/yr

... medical device contract manufacturer where collaboration, continuous improvement, and customer focus drive everything we do. As Director of Supply Chain, you will provide strategic and operational ...

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Medical Device Operations information

What is 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?

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.

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 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 the most commonly searched types of Medical Device Operations jobs in Ohio?

The most popular types of Medical Device Operations jobs in Ohio are:

What are popular job titles related to Medical Device Operations jobs in Ohio?

For Medical Device Operations jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Medical Device Operations jobs in Ohio look for?

The top searched job categories for Medical Device Operations jobs in Ohio are:

What cities in Ohio are hiring for Medical Device Operations jobs?

Cities in Ohio with the most Medical Device Operations job openings:

Medical Device Operations jobs near you
Infographic showing various Medical Device Operations job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 74% Full Time, 17% Part Time, and 8% Contract. Highlights an 85% Physical, 1% Hybrid, and 14% Remote job distribution.

Principal Engineer - Drug Delivery Device Development (Electro-Mechanical Combination Products)

3 Key Consulting

New Albany, OH • On-site

$52 - $57/hr

Full-time

Re-posted 21 days ago

Job description

Job Title: Principal Engineer - Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process Development
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 06/15/26
Pay Rate: $52 - $57/hour W2
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5

3 Key Consulting is hiring a Principal Engineer - Drug Delivery Device Development (Electro-Mechanical Combination Products) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month. International travel may be required for this position.

Candidate will lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as:

  • Needle protection systems
  • Fluid transfer devices
  • Pen injectors
  • Automatic pen injectors
  • Micro-infuser delivery pump systems.

The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. They will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.

The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Why is the Position Open?
Planned Project

Top Must Have Skills:
Material & test specs generation, protocol & report writing.
Process & test development, prototyping, design verification.
DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Nice to have: packaging process experience

Day to Day Responsibilities:
Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.

  • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Create and execute to project plans and schedules.
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
  • Provide deep technical assistance for junior engineers.

Basic Qualifications:

  • BS in Engineering and previous experience in a medical device industry.
  • Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience
  • 10 years current experience with engineering processes and procedures.
  • Led projects from development through the 510k and PMA approval process.
  • Strong background in engineering and commercialization of electro-mechanical medical devices.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in drug/device combination product design and development
  • Familiar with the following standards:
    • Quality System Regulation 21CFR820
    • Risk Management ISO 14971
    • EU Medical Device requirements
    • Council Directive 93/42/EEC
    • Medical Electrical Equipment EN 60601
  • Small scale device assembly experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Strong problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.
  • VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!

Red Flags:
Not flexible for the working shift/hours required and limitation to travel. Approximately 1-2x per month
Unable to travel internationally

Interview process:
One round panel interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Regards,

3KC Talent Acquisition Team

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