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Full Time Medical Device Engineer Jobs in Ohio (NOW HIRING)

Gentherm

Senior Quality Engineer

Cincinnati, OH · On-site

$85K - $115K/yr

JOB TITLE Senior Quality Engineer ESSENTIAL FUNCTIONS AND RESPONSIBILITIES Senior Quality Engineer for Cincinnati, OH medical device manufacturer to maintain and improve Quality Management System to ...

ICU Medical

Engineer III, Sustaining

Dublin, OH · On-site

$88K - $108K/yr

Knowledge of medical device packaging systems, packaging validation, and accelerated aging methodologies. * Experience managing engineering change processes within a regulated manufacturing ...

New

ICU Medical

Engineer III, Sustaining

Dublin, OH · On-site

$88K - $108K/yr

Knowledge of medical device packaging systems, packaging validation, and accelerated aging methodologies. * Experience managing engineering change processes within a regulated manufacturing ...

Resonetics

Quality Engineer I

Dayton, OH

$63K - $82K/yr

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're ... Employment Type: FULL_TIME

Resonetics

Quality Engineer I

Dayton, OH · On-site

$54K - $84K/yr

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're ... For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable ...

Resonetics

Quality Engineer I

Dayton, OH

$63K - $82K/yr

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're ... For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable ...

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All JobsMedical Device Engineer JobsFull Time Medical Device Engineer JobsFull Time Medical Device Engineer Jobs in Ohio

Full Time Medical Device Engineer information

What is the difference between Full Time Medical Device Engineer vs Medical Device Quality Engineer?

AspectFull Time Medical Device EngineerMedical Device Quality Engineer
Required CredentialsBachelor's in Engineering, certifications like CQA or Six Sigma beneficialBachelor's in Engineering or Life Sciences, certifications like CQE or ISO auditor
Work EnvironmentDesign labs, R&D departments, manufacturing facilitiesQuality assurance labs, compliance departments, manufacturing sites
Employer & Industry UsageMedical device companies, biotech firms, healthcare device manufacturersMedical device companies, regulatory agencies, compliance firms
Common Search & ComparisonYesYes

Full Time Medical Device Engineers focus on designing, developing, and testing medical devices, working closely with R&D teams. Medical Device Quality Engineers concentrate on ensuring products meet quality standards and regulatory requirements. Both roles are essential in the medical device industry but differ in their primary responsibilities and work environments.

What are the most commonly searched types of Medical Device Engineer jobs in Ohio? The most popular types of Medical Device Engineer jobs in Ohio are:
What are popular job titles related to Full Time Medical Device Engineer jobs in Ohio? For Full Time Medical Device Engineer jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Full Time Medical Device Engineer jobs in Ohio look for? The top searched job categories for Full Time Medical Device Engineer jobs in Ohio are:
What cities in Ohio are hiring for Full Time Medical Device Engineer jobs? Cities in Ohio with the most Full Time Medical Device Engineer job openings:
Full Time Medical Device Engineer jobs near you
Infographic showing various Full Time Medical Device Engineer job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Sr. Engineer, Combination Products & Medical Device

Hikma Pharmaceuticals PLC

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 28 days ago

Hikma Pharmaceuticals rating

8.0

Company rating: 8.0 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

43rd of 86 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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