Midmark Corporation · 16 hours ago
R+D Quality Engineer
Versailles, OH
Full-time
Onsite
Entry, Mid Level
2+ years expMidmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. The R + D Quality Engineer II leads product development quality initiatives, ensuring robust design and manufacturability of medical devices.
Health CareManufacturingMedical Device
Responsibilities
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
Assists with safety risk management processes and creation of 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
Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques
Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes
Mentors co-op and engineer I teammates, focusing on technical skills and cultural competencies
Expands problem definition, integrates new information and different perspectives, and chooses optimal solution based on evidence
Supports internal and external quality system audits
Assists with the creation of threat models and cybersecurity risk assessments
Assists with 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
Qualification
Required
Bachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent combination of both
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
Assists with safety risk management processes and creation of 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
Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques
Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes
Mentors co-op and engineer I teammates, focusing on technical skills and cultural competencies
Expands problem definition, integrates new information and different perspectives, and chooses optimal solution based on evidence
Supports internal and external quality system audits
Assists with the creation of threat models and cybersecurity risk assessments
Assists with 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
Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
Strong written and verbal communication skills
Advanced analytical skills, ability to define and analyze complex problems
Ability to generate alternatives and take reasonable risks to solve technical problems
Provides leadership, coaching, and/or mentoring to co-op's and level I engineers
Preferred
Six Sigma Blackbelt (DMAIC, DMADV) Certification is 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
Recent News
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