Job Description
Position Summary
The Senior Product Engineer – Consumables will be responsible for executing key product engineering activities to support portfolio expansion and on-market engineer projects for the Consumable IV Set product lines. The Senior Product Engineer will be responsible for Design Controls, including Requirements Management, Design Outputs, Verification & Validation, Design History File management, and Risk File management. This engineer will author protocols and reports, conduct data analysis, and guide and mentor other engineers and cross-functional colleagues.
This is a senior engineering role that is expected to have experience in the development and maintenance of medical device products. The Senior Product Engineer will be expected to execute on key projects of a complex nature and consistently demonstrate and develop their technical leadership skills in medical device product development and engineering core competencies.
Essential Duties & Responsibilities
- Work with cross-functional teams in a technical leadership capacity to ensure product designs will meet customer expectations while delivering critical IV therapies safely and effectively. Network with internal and external personnel.
- Work on significant and unique issues where analysis of situations or data requires an evaluation of intangible factors.
- Develop Design Requirements, Inputs, and Outputs for multiple projects and products.
- Develop Design Verification and Validation Plans, Protocols, and Reports, including test method validation and statistical data analysis.
- Plan, execute, and document Technical Design Reviews and Phase Reviews throughout the product development process.
- Execute design changes and product portfolio expansion launches in a timely and efficient manner, directly impacting product design and business success.
- Support Requirements and Risk Management for the Consumable IV Set portfolio.
- Work on projects that address future concepts, product portfolio expansions, or technologies, as needed.
- Support on-market engineering activities.
- Work on special projects as they arise.
- Exercises independent judgment in methods, techniques, and evaluation criteria for obtaining results.
Knowledge & Skills
- Strong technical writing and communication skills
- Experience with medical device products, Design Controls, and Design History Files per 21 CFR Part 820, ISO 13485, and ISO 14971
- Experience with on-market issue troubleshooting and resolution
- Experience with global medical device standards and regulations
- Understanding of medical device CAPA investigation process
- Experience with requirements management tools (DOORS and/or DNG preferred)
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor’s degree in engineering from an accredited college or university is required, advanced degree preferred
- 7+ years of related experience required, preferably in medical device product development
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
- Operator is required to use computer or touch screen to enter work order data
- Must be able to occasionally move and lift objects of up to 25 pounds
- Typically requires travel less than 5% 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
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
