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Open nowPosted yesterday

R+D Quality Engineer II

Midmark Corporation43 open roles

Where
Versailles, OH, United States
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Your applicationOpen nowR+D Quality Engineer IIMidmark Corporation · Versailles, OH, United States

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The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market. Midmark Corporation postings stay open a median of 15 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted yesterday

Midmark Corporation median: 15 days open

The posting

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 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.
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