R+D Quality Engineer
About The Position
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.
Requirements
- Bachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent combination of both.
- 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
Nice To Haves
- Six Sigma Blackbelt (DMAIC, DMADV) Certification is preferred.
Responsibilities
- 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).
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
