R+D Quality Engineer II

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 ISO
  9001:2015, ISO
  13485:2016, ISO
  14971, 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.