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Katalyst HealthCares & Life Sciences ยท 1 week ago
Design Assurance Engineer
St Paul, MN
Contract
Onsite
Mid Level
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Responsibilities
A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system.
You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance.
You will monitor quality assurance efforts to ensure that the companys products conform to quality standards.
You will partner with research/development and manufacturing engineering during new product start-ups and establish checkpoints for testing new products and processes.
The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.
Ensure companys adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
Manage new product Design History Files.
Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
Aide in definition of test equipment as required to accomplish quality responsibilities.
Develops and documents test plan protocols, test procedures, and test reports.
Perform tests according to various protocol requirements.
Lead completion of risk management and risk analysis including FMEA.
Devise design verification and design validation plans for products based on performance specifications and risk analysis
Analyze and communicate conformance to specifications and standards.
Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
Support completion of in vitro testing including applicable animal studies.
Aid in definition of supplier quality specifications, sampling plans, and vendor qualification.
Assist in specifications and testing of sterilization methods.
Lead system and product continuous improvement teams. 16. Reviews Engineering Change Orders, as required.
Perform other duties and responsibilities as assigned by senior management.
Qualification
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Required
Software development lifecycle, verification and methodologies, equipment validation
Verification plans, configurations, acceptance
Qualifying equipment
Equipment or tools for R&D
Preferred
Computer science, medical software development experience highly preferred
Strong biomedical/med device experience preferred
Test validation experience is a secondary preferred skill set
Does not need software coder
Company
Katalyst HealthCares & Life Sciences
Katalyst Healthcares & Life Sciences offers data management, analysis, quality assurance, pharmacovigilance, and human resource services.
51-200 employees
H1B Sponsorship
Katalyst HealthCares & Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (20)
2022 (46)
2021 (43)
2020 (53)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase
