Senior Designer creating refined design solutions at Instrument. Leading design workstreams and fostering quality and clarity across teams.
About the role
- Quality Engineer providing support for ICU Medical development through CAPA investigations and ensuring compliance with quality standards. Engage in design reviews and risk assessments in a professional office environment.
Responsibilities
- Provide quality support for ICU Medical Hardware and Consumable development.
- Support activities such as CAPA investigations, design projects, and ensure compliance with quality system requirements.
- Utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc.
- Assure conformance with regulations of the FDA and other international regulatory agencies.
- Ensure all Quality attributes for design changes are met.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, and design transfers.
- Evaluate, prioritize, and mitigate potential product and process risks to improve quality.
- Support internal and/or external audits and inspections.
- Effectively interact with cross-functional team members.
- Provide quality support for on-market product issues, bringing issues to closure.
Requirements
- Must be at least 18 years of age
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
- Minimum of 2 - 4 years of experience in R&D and/or Quality is required.
- ASQ CQE certification preferred or ability to obtain within one year.
Benefits
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
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