Design engineer [h1.location_city]
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Design engineer • waterbury ct
[last_updated.last_updated_1_hour]
Essential Duties & Responsibilities.Effectively utilize quality tools and processes such as product and process controls, risk analysis / management tools, validation, design verification, investigat...[show_more][last_updated.last_updated_variable_days]
Superprof is the leading tutoring platform in the USA, connecting passionate individuals with eager learners.We operate in over 63 countries, making education accessible to everyone, everywhere.Sup...[show_more][last_updated.last_updated_30]
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Sales Engineer – Civil Site Industry.Overview : Our client, a leading manufacturer of civil construction products, is seeking a Sales Engineer for their New England territory.Position : This is...[show_more][last_updated.last_updated_variable_days]
Responsible for analyzing, developing, and specifying manufacturing processes, including operational sequences, tooling, methods, equipment, and controls.
Ensures processes meet quality and quantity...[show_more][last_updated.last_updated_variable_days]
Lane Construction is one of America's leading construction companies, specializing in large, complex civil infrastructure.
For 135 years, it has contributed to the development of the country's trans...[show_more][last_updated.last_updated_variable_days]
RBC Bearings Incorporated (NYSE : RBC / RBCP) is a leading international manufacturer of highly engineered precision bearings, components and essential systems for the industrial, defense and aerospac...[show_more][last_updated.last_updated_variable_days]
Winterberry Irrigation - Full Time.Winterberry Irrigation is looking for a motivated and detail-oriented Design & Estimating Assistant to join our growing team.
This is a fantastic opportunity for s...[show_more][last_updated.last_updated_variable_days]
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience.
At CVS Health®, you’ll be surrounded by passionate colleagues who...[show_more][last_updated.last_updated_1_day]
This Jobot Job is hosted by : Colleen Gormley.Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.
Salary : $115,000 - $130,000 per year.Our client, a ...[show_more][last_updated.last_updated_30]
At Iron Mountain we know that work, when done well, makes a positive impact for our customers, our employees, and our planet.
That’s why we need smart, committed people to join us.Whether you’re loo...[show_more][last_updated.last_updated_variable_days]
Responsible for analyzing, developing, and specifying manufacturing processes, including operational sequences, tooling, methods, equipment, and controls.
Ensures processes meet quality and quantity...[show_more][last_updated.last_updated_1_hour]
Electro-Mechanical Designer – East Windsor, CT area Our client has both New Product Development for new technology products AND of their legacy niche products that the company was founded on sixty ...[show_more][last_updated.last_updated_variable_days]
At Sikorsky, a Lockheed Martin Company, we are at the forefront of aerospace innovation, driving the development and deployment of cutting-edge technology in the field of aviation.We solve the grea...[show_more][last_updated.last_updated_variable_days]
This position will be working on advanced wireless and RF solutions.For our prestigious client, we are seeking a self-motivated Electrical Engineer to join embedded systems development team to deli...[show_more][last_updated.last_updated_30]
This job supports the matrixed strategic design and analytical approach to reimbursement.To be successful, the incumbent will work closely with stakeholders across the enterprise in the development...[show_more][last_updated.last_updated_30]
Are you interested in working for a company that fosters growth opportunities, community involvement and a team-oriented atmosphere? ClarkDietrich fosters a work-life balance and offers competitive...[show_more][last_updated.last_updated_variable_days]
Sales Engineer - Civil Site Industry.Overview : Our client, a leading manufacturer of civil construction products, is seeking a Sales Engineer for their New England territory.Position : This is a rem...[show_more][last_updated.last_updated_variable_days]
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Senior Engineer Design Quality - Consumables
ICU MedicalSouthington, CT, United States[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 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 and manufacturing team members Must be at least 18 years of age Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Software) from an accredited college or university is required. Minimum of 7+ years of experience in R&D or Quality is required ASQ CQE or CSQE required or the ability to obtain within one year. 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 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.
Job Description
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.
- Work special projects as assigned
Knowledge & Skills
ISO 13485
Minimum Qualifications, Education & Experience
Work Environment
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 :
ICU Medical EEO Statement :
ICU Medical is committed to being an 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, 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
Know Your Rights : Workplace Discrimination is Illegal Poster
ICU Medical CCPA Notice to Job Applicants