R+D Quality Engineer

Midmark Corporation • Versailles, OH

6d

About The Position

The R + D Quality Engineer II leads product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.

Requirements

• Bachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent combination of both.
• 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

Nice To Haves

• Six Sigma Blackbelt (DMAIC, DMADV) Certification is preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees