Midmark Corporation · 17 hours ago
R+D Quality Engineer III
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
4+ years expMidmark Corporation is a company transforming healthcare experiences through innovative design within the medical, dental, and animal health environments. The R+D Quality Engineer III leads and enforces product development quality initiatives, ensuring robust and quality design and manufacturability of medical devices while collaborating with cross-functional teams and mentoring junior engineers.
Health CareManufacturingMedical Device
Responsibilities
Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations
Leads all risk management processes and creates risk management documentation for (NPD) projects
Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records
Facilitates the design and process failure mode and effects analysis (FMEA) process
Leads site-based quality department initiatives as a subject matter expert (SME)
Applies domain expertise to the application and advancement of engineering methods and tools. Leads the application of six sigma techniques and drives continuous process improvement
Collaborates with cross-functional teams to align decisions with business goals
Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies
Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort
Supports internal and external quality system audits
Leads the creation of threat models and cybersecurity risk assessments
Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact
Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results
Qualification
Required
Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both
Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations
Leads all risk management processes and creates risk management documentation for (NPD) projects
Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records
Facilitates the design and process failure mode and effects analysis (FMEA) process
Leads site-based quality department initiatives as a subject matter expert (SME)
Applies domain expertise to the application and advancement of engineering methods and tools
Leads the application of six sigma techniques and drives continuous process improvement
Collaborates with cross-functional teams to align decisions with business goals
Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies
Applies advanced tools and methods to solve complex problems
Tackles technical challenges and contributes to troubleshooting effort
Supports internal and external quality system audits
Leads the creation of threat models and cybersecurity risk assessments
Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact
Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results
Experience in the medical device industry and understanding of medical device quality systems and applications
Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
Strong written and verbal communication skills
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
Provides leadership, coaching, and/or mentoring to level I and level II engineers
Preferred
Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability Engineer (CRE) certifications preferred
Company
Midmark Corporation
Midmark Corp manufactures and supplies medical, dental, and animal health products.
1001-5000 employees
H1B Sponsorship
Midmark Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (1)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Susan Martin
Vice President & Midmark RTLS
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