Katalyst CRO ยท 2 months ago
Senior Design Assurance Engineer
Marlborough, MA
Contract
Onsite
Mid, Senior Level
2+ years expKatalyst Healthcares & Life Sciences is focused on providing design assurance support for new product development and on-market medical devices. This role involves facilitating the application of design controls, maintaining regulatory compliance, and implementing improvements for manufacturability while evaluating cost reduction efforts.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs
Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Test method validation would be an element of assuring verification/validation is acceptable
Participate independently in doing thorough reviews/audit of Design History File(DHF) documentation for capital and disposable medical devices, including design plans, design inputs/outputs, verification/validation activities, design changes, and design transfer documentation
Participate independently on thorough reviews/audit Requirements Trace Matrix and assuring the trace matrix is accurate and meeting design control requirements for medical devices
Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed
Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies
Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact
Assess change requests of product for impact to design, determine supporting information required for implementation of changes
Qualification
Required
Technical bachelor's degree
2-5 years' experience preferably in medical device industry
Experienced with FDA Quality System Regulations, specially Design Control requirements, ISO 13485 and Medical Device Directive
Experienced with ISO 14971, Risk Management
Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements
Working knowledge of verification and validation requirements for a regulated product
Working knowledge of requirements analysis, including development of testable and measurable specifications
Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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