Job Title: Sr Design Quality Engineer
Position Summary
Provide quality support for ICU Medical Inc. medical device design development. The Sr. Quality Engineer will be responsible for design and development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. Reporting to the Quality Manager, this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed. Will work directly on new product development and on-market sustaining engineering teams.
Keys: DHF ownership and development. Must have expert design history file experience with medical devices.
Essential Duties & Responsibilities
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
- Work with cross-functional teams to coordinate product changes.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Provide corporate quality support, guidance, and direction for brining on-market product issues to closure and escalating to senior management for support as necessary.
- Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.
- Ensure compliance, alignment, and consistency with ICU Medical’s quality system.
- Prepare, support, and ensure the readiness for any potential internal and/or external audits and inspections.
Knowledge, Skills & Qualifications
- Expert quality compliance, audit, and investigation skills
- Expert and detailed DHF skills and experience.
- In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
- Strong knowledge of medical device standards, including but not limited to:
- ISO 13485
- ISO 14971
- IEC 60601
- In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
- Risk management: plan, report dFMEA, uFMEA and risk summary
- EU MDR , MDR, FDA, New Product Investigations
- Proven ability to work closely with engineering and manufacturing team members
Education and Experience
- Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
- Master’s degree preferred.
- 7+ years’ experience in R&D or Quality product design is required.
- ASQ CQE certification required or the ability to obtain within one year.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
US-IL-Lake Forest
Schedule
Full-time
Shift
Day Job
