R+D Quality Engineer II

Midmark Corporation • Versailles, OH

1d

About The Position

The R+D Quality Engineer II leads product development quality initiatives by identifying, investigating, planning, and conducting activities to ensure robust, high-quality medical-device design and manufacturability. The role manages quality deliverables for new product development projects and supports risk management, engineering documentation, design and process FMEAs, quality improvements, and cross-functional technical solutions. It also provides coaching and mentoring to co-op and Engineer I teammates.

The position additionally supports internal and external quality system audits, cybersecurity threat modeling and risk assessments, usability engineering documentation, and reliability predictions and recommended testing profiles.

Requirements

• Bachelor's degree in engineering or a related field and 2+ years of relevant experience, or an equivalent combination of education and experience.
• Mastery of Microsoft Word, PowerPoint, Excel, Project, and Minitab.
• Strong written and verbal communication skills.
• Advanced analytical skills and ability to define and analyze complex problems.
• Ability to generate alternatives and take reasonable risks to solve technical problems.

Nice To Haves

• Six Sigma Black Belt certification (DMAIC, DMADV).

Responsibilities

• Manage quality deliverables on new product development projects in accordance with ISO 9001:2015, ISO 13485:2016, ISO 14971, FDA, CSA, and EU MDR requirements.
• Assist with safety risk management processes and create risk management documentation for new product development projects.
• Create, review, and approve engineering Product Realization Process documentation, including change requests, engineering orders, product and component test specifications, and design records.
• Facilitate design and process failure mode and effects analysis (FMEA).
• Apply advanced engineering methods and tools to solve engineering problems.
• Identify and contribute to process improvements using Six Sigma techniques.
• Collaborate with cross-functional and development teams to address quality concerns, drive improvements, and own technical solutions and outcomes.
• Mentor co-op and Engineer I teammates in technical skills and cultural competencies.
• Define problems broadly, integrate new information and perspectives, and select evidence-based solutions.
• Support internal and external quality system audits.
• Assist with creating threat models and cybersecurity risk assessments.
• Assist with creating and maintaining product Usability Engineering Files, developing misuse cases involving use error, and assessing their impact.
• Assist with creating project reliability predictions and recommended testing profiles.
• Provide leadership, coaching, and mentoring to co-op and level I engineers.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level