New · posted Oct 15
Midmark · Medical Devices
Senior Mechanical Design Engineer (Product Quality)
- Versailles, OH
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
Leads the efforts to identify, investigate, plan, and conduct activities to improve or ensure quality through design and manufacturing of medical devices and components. Leads cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components. Will act as the subject matter expert (SME) on elements within the quality department.
What you need
EDUCATION and/or EXPERIENCE
Bachelor's degree in engineering or related field and 6+ 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
- Experience in the medical device industry and understanding of medical device quality systems and applications is desired
- Ability to effectively influence and negotiate with all levels of an organization and lead effective/successful change initiatives
- Ability to establish and enforce quality standards that align with industry best practices and regulatory requirements
- Expert problem solver in areas of expertise
- Ability to lead the design of complex, interconnected systems or processes and shape the organization's technical direction
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.
- Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk.
- Formulates solutions to complex and ambiguous problems that are not well defined. Incorporates feedback and solutions from others.
- Communicates complex technical ideas through daily work, presentations, and workshops.
- Fosters cross team communication and knowledge sharing. Collaborates with teams and management to make critical technical decisions that align with organizational goals.
- Collaborates with leadership and other cross functional departments to align decisions with organizational goals.
- Champions six sigma techniques and drives standardization through continuous process improvement.
SECONDARY DUTIES
- Identifies and manages Six Sigma projects internal and external to the quality department as well as suppliers.
- Provides leadership, coaching, and/or mentoring to the co-op group and level I, II & III engineers.
- Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.
- Teaches and provides guidance on 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, II and level III engineers.
- May have direct reports of technicians or level I & level II engineers.
Where you'll work
Versailles, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Versailles, OHJob 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 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Quality systems and risk5
- GMP and compliance3
- Documentation and SOPs2
- Investigations and CAPA2
- Lab testing and methods1
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%
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Senior Mechanical Design Engineer (Product Quality) at Midmark
Open until filled.