Midmark Corporation · 3 months ago
R+D Quality Engineer III
9987 Carver Road, Blue Ash, OH, 45242, US
Full-time
Onsite
Mid, Senior Level
4+ years expMidmark Corporation is focused on improving healthcare through quality engineering, and they are seeking a R+D Quality Engineer III to lead product development quality initiatives. The role involves managing quality deliverables, leading risk management processes, and collaborating with cross-functional teams to ensure robust design and manufacturability of medical devices.
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
4+ years of relevant experience, or equivalent combination of both
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
Preferred
Certified Quality Engineer (CQE)
Six Sigma Blackbelt (DMAIC, DMADV)
Certified Reliability Engineer (CRE)
Experience in the medical device industry and understanding of medical device quality systems and applications is desired
Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
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
Recent News
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