R+D Quality Engineer II

Midmark Corporation • Versailles, OH

1d

About The Position

The R+D Quality Engineer II leads product development quality initiatives to ensure robust design and manufacturability of medical devices. The role manages quality deliverables for new product development projects and supports risk management, engineering documentation, design and process FMEAs, quality system audits, cybersecurity risk assessments, usability engineering files, and reliability predictions. The position also applies advanced engineering methods and Six Sigma techniques to resolve problems and improve processes, collaborates with cross-functional development teams, and mentors co-op and Engineer I teammates.

Requirements

• Bachelor’s degree in engineering or a related field and at least 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, including DMAIC and DMADV.

Responsibilities

• Manage quality deliverables for 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 documentation for the engineering Product Realization Process, 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 their outcomes.
• Mentor co-op and Engineer I teammates, focusing on technical skills and cultural competencies.
• Expand problem definitions, integrate new information and perspectives, and select evidence-based solutions.
• Support internal and external quality system audits.
• Assist with threat models and cybersecurity risk assessments.
• Assist with creating and maintaining product Usability Engineering Files, providing misuse cases involving use error, and assessing their impact.
• Assist with reliability predictions for projects and recommend testing profiles.
• Provide leadership, coaching, and/or mentoring to co-op teammates and Level I engineers.

What This Job Offers

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