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.
Skills Required
- Bachelor's degree in engineering or a related field, or equivalent combination of education and experience
- Two or more years of relevant experience, unless substituted by an equivalent combination of education and experience
- Proficiency with Microsoft Word, PowerPoint, Excel, Project, and Minitab
- Strong written and verbal communication skills
- Advanced analytical skills and ability to analyze complex problems
- Ability to generate alternatives and take reasonable risks to solve technical problems
- Six Sigma Black Belt certification, including DMAIC and DMADV
What We Do
Midmark Corporation is the only clinical environmental design company that enables a better care experience for the medical, dental and animal health markets. With nearly 2,000 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. Visit midmark.com/careers for information on current career opportunities.
