R+D Quality Engineer II

Midmark Corporation; Versailles (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Midmark Corporation seeks an R&D Quality Engineer II to lead quality initiatives across new product development, ensuring robust design and manufacturability of medical devices. You will participate in risk assessments, documentation, and continuous improvement using Six Sigma tools.

Ideal candidates have a engineering degree, 2+ years of relevant experience, and strong analytical and communication skills to mentor junior engineers and work with cross-functional teams in a regulated environment.

Qualifications

• Bachelor's degree in engineering or related field with 2+ years of experience.
• Six Sigma Black Belt certification preferred.
• Strong MS Office and Minitab proficiency.
• Excellent communication and analytical problem-solving.

Responsibilities

• Lead quality deliverables on NPD projects per ISO/FDA regulations.
• Assist with safety risk management and risk documentation.
• Create/review PRP-related documentation (change requests, test specs, design records).
• Facilitate FMEA process and drive process improvements using Six Sigma.
• Mentor/co-op and engineer I teammates; collaborate with cross-functional teams.

Skills

Quality engineering

Risk management

FMEA

Six Sigma

Data analysis

Cross-functional

Education

Bachelor's degree in engineering

Six Sigma Black Belt preferred

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.

Job Description

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 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.

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.