New · posted Oct 15
Midmark · Medical Devices
Mechanical Design Engineer (Product Quality)
- Versailles, OH
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
Identifies, investigates, plans, conducts, and leads activities to improve or ensure quality through design and manufacturing of medical devices and components. Cross-functionally collaborates with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components.
What you need
EDUCATION and/or EXPERIENCE
Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications are preferred.
COMPETENCY and/or SKILL
- Fully understand basic engineering tools and methods
- Experience in the medical device industry and understanding of medical device quality systems and applications
- Ability to analyze existing processes and lead process improvement efforts
- Ability to apply advanced analytical tools and methods to solve complex problems
- Ability to lead the design of complex systems and identify new technological opportunities
What you'll do
ESSENTIAL/PRIMARY DUTIES
- Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
- Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
- Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
- Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort.
- Leads the application of six sigma techniques and drives continuous process improvement.
- Plans, implements, and optimizes complex solutions for small to medium sized projects and teams.
- Influences change within and across disciplines.
- Defines quality metrics, leads investigations, and communicates quality status.
- Leads or participates in cross-functional projects, defines KPIs, leads change management as the site-based quality department subject matter expert (SME).
- Facilitates the design and process failure mode and effects analysis (FMEA) process.
SECONDARY DUTIES
- Provides leadership, coaching, and/or mentoring to the co-op group and level I & II engineers.
- Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.
- Understands engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.
SUPERVISORY RESPONSIBILITIES
- Provides leadership, coaching, and/or mentoring to level I and level II engineers.
Where you'll work
Versailles, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Versailles, OHWorking conditions
Work Authorization
Midmark Corporation will only employ those who are legally authorized to work in the United States. This is not a position for which sponsorship will be provided. Individuals with temporary visas or who need sponsorship for work authorization now or in the future, are not eligible for hire.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Midmark's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Quality systems and risk6
- Lab testing and methods4
- GMP and compliance3
- Investigations and CAPA3
- Documentation and SOPs1
Company hiring pulse
Midmark on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 1
- Locations
By discipline
- Quality4 100%
By level
- Senior & Principal3 75%
- Associate & Specialist1 25%
More roles at Midmark
- View role
R+D Quality Engineer III
Versailles, OHSenior & PrincipalMedical DevicesSalary not listed
- View role
Quality Engineer I
Versailles, OHAssociate & SpecialistMedical DevicesSalary not listed
- View role
Senior Mechanical Design Engineer (Product Quality)
Versailles, OHSenior & PrincipalMedical DevicesSalary not listed
Similar Quality Assurance roles elsewhere
- View role
Quality Engineer II
STERISMentor, OHSenior & PrincipalMedical Devices$80K
- View role
Senior Supplier Quality Engineer
iRhythmOrange County, CA · HybridSenior & PrincipalMedical Devices$99K–$129K
- View role
Senior Design Quality Engineer
iRhythmSan Francisco, CA +1 more · HybridSenior & PrincipalMedical Devices$138K–$180K
- View role
Senior Supplier Quality Engineer
The Cooper CompaniesTrumbull, CT +1 more · HybridSenior & PrincipalMedical Devices$100K–$125K
Mechanical Design Engineer (Product Quality) at Midmark
Open until filled.