Senior Engineer, Design Quality - Hybrid at ICU Medical, Inc. in San Diego, California

Job Description:

Job Description



Position Summary

Provide quality support and assurance for ICU Medical software development. The Software Quality Engineer will be responsible for software development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as FDA QSR and IEC 62304).



Essential Duties & Responsibilities

• Ensure the safety of the software products developed by managing the software product life cycle activities to meet the quality system requirements.
• Ensure compliance, alignment and consistency with ICU Medical's quality system and software development practices.
• Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
• Perform periodic audits of projects against SOP's and process.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
• Review, approve and participate in qualification of acquired software and software tools.
• Review and approve resolution of released software issues.
• Support regulatory submissions
• Perform and support software risk analysis and management
• Support software issue investigations, risk assessments and associated CAPA activities
• Work on special projects as they arise

Knowledge, Skills & Qualifications

• The following is required:
• Expert quality compliance, audit, and investigation skills
• 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
  • IEC 62304
  • ISO 14971
  
  
• In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
• Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
• Proven ability to work closely with engineering teams and members of a cross functional team
• New product software development experience is strongly preferred.
• Cloud development experience is strongly preferred.

Education and Experience

• Must be at least 18 years of age
• Bachelor's degree in software engineering or related field from an accredited college or university is required.
• 7+ years of experience in software quality engineering, product design or product engineering in the medical device industry
• ASQ CSQE required or the ability to obtain within one year.

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel 5% to 10% of the time

Salary Range - $105,000 - $150,500

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.

ICU Medical provides a comprehensive total rewards package that includes:

• 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

Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.



About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement


OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants Apply Now