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Medical Device Operations Jobs in Ohio (NOW HIRING)

ConfigUSA

Medical Device Support

Blue Ash, OH · On-site

... and operations to ensure equipment meets specifications and transitions smoothly to production ... Medical Device & Regulations~EIS : Manufacturing Engineering Support

Lincotek Medical

Polisher - Medical Device

Vandalia, OH · On-site

$16 - $20.75/hr

Optimizes finishing operations in the most efficient manner. * Uses hand tools, air tools or ... Ability to read blueprints. Lincotek Medical provides equal employment opportunity to all ...

Multi Radiance Medical

Be Seen First

Marketing Operations Manager

Solon, OH · On-site

$62K - $70K/yr

... medical device, or regulated industries is a plus WHAT WE'RE LOOKING FOR · Experience with HubSpot or a similar CRM/marketing automation platform. · Familiarity with email marketing, landing pages ...

NML Medical

Director of Operations

Carrollton, OH · On-site

The Director of Operations leads end-to-end manufacturing performance across safety, quality, delivery, cost and talent development within a regulated medical device environment. This role is ...

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Medical Device Operations information

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.
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:
Medical Device Operations jobs near you
Infographic showing various Medical Device Operations job openings in Ohio as of June 2026, with employment types broken down into 92% Full Time, and 8% Part Time. Highlights an 100% In-person job distribution.
Sr. Engineer, Combination Products & Medical Device

Sr. Engineer, Combination Products & Medical Device

Hikma Pharmaceuticals PLC

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 7 days ago

Hikma Pharmaceuticals rating

7.8

Company rating: 7.8 out of 10

Based on 29 frontline employees who took The Breakroom Quiz

39th of 71 rated pharmaceutical

Job description

Job Title: Sr. Engineer, Combination Products & Medical Device
Location: Columbus, OH
Job Type: Full time
Req ID: 11621
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Engineer, Combination Products & Medical Device to join our team.
In this role, you will be responsible for providing Combination Product and Medical Device Quality System Framework and Design expertise both within local operations and to drive best practices within the global organization.
Support includes ensuring that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site.
Responsibility also includes assessing, evaluating, identifying and implementing required documentation and studies to support requirements for launch, lifecycle changes and Business Development opportunities to meet identified business objectives and targets.
Key Responsibilities:
Knowledge Management
  • Stay up to date on regulations and regulatory trends to ensure that practices and procedures remain current with regulatory health authorities' expectations with regards to Combination Products and Medical Devices i.e. 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO14971, etc...
  • Supports Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed
  • Active member of relevant industry groups and key stakeholder organizations
  • Direct the work of consultants as needed and mentor others
  • Responsible for driving site education with regards to combination products and medical device requirements and organizational processes.

Infrastructure Support
  • Develop and ensure lifecycle management of a Quality Management System to be compliant with all relevant combination product and medical device regulations
  • Work within a Center of Excellence to share and align on best practices across Hikma Operating Units
  • Facilitate and/or supports the development and implementation of combination product and medical device quality governance processes and procedures
  • Develops and drives Risk Management approach
  • Contributes in relevant Quality Governance meetings

Project Support
  • Leads and/or participates on departmental and/or cross-functional teams as Combination Product and Medical Device SME
  • Performs gap assessments of processes and procedures against relevant device regulations
  • Develops recommendations and proposals to address identified gaps and provides expert guidance for projects
  • Drives, as appropriate, key activities such as risk analysis, FMEA and threshold analysis for active projects
  • Drive required Statements of Work with consultants where needed to support specific product programs e.g. device reliability, human factor studies, threshold analysis, FMEA, and/or risk analysis
  • Drives change control support for Combination Product & Medical Device requirements assessment and deliverable review
  • Provide support for relevant investigations and CAPA(s)
  • Provides guidance on approach and regulatory responses support for health authority questions to support product approvals
  • Other duties as assigned
  • Predictable, consistent onsite attendance required

Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
  • B.S. in engineering field (e.g. pharmacy, chemical, medical device, packaging or mechanical) with 10+ years direct experience at a medical device manufacturer or combination product manufacturer
  • M.S. in engineering field with 5+ years direct experience at a medical device manufacturer or combination product manufacturer

Business & Technical Expertise
  • Strong understanding of business development, lifecycle management, and long-term planning.
  • Subject matter expert in combination products and medical devices, including design controls, risk management, validation, reliability, and process controls.
  • Deep knowledge of pharmaceutical principles and complex dosage forms (e.g., nasal suspensions, dry powder inhalers, novel delivery systems).
  • Experienced in manufacturing, packaging, and device production processes.

Customer Focus
  • Champions quality and customer service excellence.
  • Aligns strategies to customer needs and market trends.
  • Establishes best practices to maintain industry-leading service standards.

Innovation & Change Leadership
  • Promotes a culture of innovation and continuous improvement.
  • Evaluates solutions against business goals and stakeholder impact.
  • Drives actionable strategies that enhance productivity and competitive advantage.

Communication & Influence
  • Effective communicator across diverse audiences; skilled in presentations, technical writing, and meeting facilitation.
  • Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Regulatory & Operational Excellence
  • Expert knowledge of pharmaceutical regulations (cGMP, FDA, DEA, ANDA requirements).
  • Strong project management experience leading cross-functional teams.
  • Able to work independently with minimal supervision.

Preferred Qualifications:
  • Experience with Class III/lifesaving combination products or medical devices; background in statistics and continuous improvement (Six Sigma Green/Black Belt preferred).
  • Strong critical thinking skills with a track record of completing complex projects and developing solutions to minimize risk and resolve issues.
  • Proven ability to manage multiple high-complexity projects, influencing cross-functional teams (PD, AD, DRA, Medical, QA, Operations, Warehouse) and external partners while meeting strict timelines.
  • Demonstrated decision-making capability, balancing risk vs. reward and independently driving tactical decisions (e.g., formulation, manufacturing processes, QbD strategy, experimental design).
  • Contributes to project planning, timelines, and budget adherence aligned with business goals.
  • Decisions primarily impact local operations with potential regional/global implications, including influence on regulatory timelines and product launch readiness.
  • Evaluates scientific and business risks to guide innovation and strategic direction.

What We Offer*:
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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