R+D Quality Engineer II

Regulatory Jobs; Ohio; On-site; USD 75,000 - 95,000; Full time

Job summary

Regulatory Jobs in the United States seeks an R&D Quality Engineer II to lead product development quality initiatives, ensuring robust design and manufacturability of medical devices in alignment with ISO 9001, ISO 13485, ISO 14971 and FDA requirements.

You will mentor co-ops and junior engineers, drive FMEA processes, support audits, and collaborate with cross-functional teams to deliver quality improvements and compliant documentation.

Qualifications

• Bachelor's degree in engineering or related field with 2+ years of relevant experience.
• Six Sigma Black Belt certification preferred.
• Strong written and verbal communication and analytical abilities.

Responsibilities

• Lead quality deliverables on new product development (NPD) projects per regulatory standards (ISO 9001:2015, ISO 13485:2016, ISO 14971, FDA, CSA, EU MDR).
• Facilitate design FMEA and risk management processes across development teams.
• Create, review, and approve documentation for Product Realization Process (change requests, test specs, design records).
• Mentor co-ops and engineers, driving technical skills and collaboration.

Skills

Communication

Analytical skills

Problem solving

Risk decision making

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft Project

Minitab

Job description

JOB SUMMARY:

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.

ESSENTIAL/PRIMARY DUTIES:

• 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.

SECONDARY DUTIES:

• Supports internal and external quality system audits.
• Assists with the creation of threat models and cybersecurity risk assessments.
• Assists with the creation 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.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent combination of both. Six Sigma Blackbelt (DMAIC, DMADV) Certification is preferred.

COMPETENCY and/or SKILL:

• 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

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to co-op’s and level I engineers.