Quality Engineer, Medical Devices, Wilmington, DE – Katalyst HLS

Medical Device Testing Analyst responsible for testing background and experience to identify, document & implement V&V process improvements and inter-departmental coordination to more efficiently conduct end to end development/test/to market cycle.


Mechanical Engineer Medical Devices Katalyst HLS

Job description:
Solid Mechanical Eng. background and system experience Very hands on Experience in medical device, biotech or other FDA-regulated industry.
Apply knowledge of general engineering principles, materials, structural mechanics and reliability to achieve product design requirements.
Provide technical expertise across areas that may include a technical specialty, a type of facility or equipment, or a program function
Interpret Buyer and marketing input to define technical design requirements, follow design control requirements to design, prototype, test and validate product concepts.
Ability to work across multiple Project teams.

Medical Devices Engineer KATALYST HLS

Job Description:
Support new product design, development and implementation of delivery devices and Client injection tools/aids for biologic therapeutics.
Primary technologies include auto-injectors, patch infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges.
Execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various medical device designs.
This will include the execution of routine and ongoing R&D stability testing, design verification testing, complaint investigations and special testing requests.
Work with design engineers and the medical device development laboratory manager to identify, develop, implement, qualify and validate new testing equipment.

Medical Device Senior Regulatory Affairs Specialist KATALYST HLS

Job Description:
Provide leadership and submission strategy in the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies (directly or with customers) for Pharmaceutical/ Device Combination Products.
Collaborate with cross-functional team to support customer filing strategy and manage regulatory activities and timelines for investigational and commercialized products.
Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation that supports agreed world-wide registration timelines.
Provide CMC regulatory guidance to project teams and Global Regulatory team.

Project Manager (Regulatory affairs, Medical devices) katalyst HLS

Primary Responsibilities and Duties:
Determine and communicate deliverables and deadlines to business unit core project teams to ensure accurate expectation setting/planning, such as any required documentation, sample types and quantities needed, expected completion dates for any deliverables. In cases of expedited requests, work with the necessary group managers to agree on accelerated timeline/strategy.
Work with toxicologists and group managers to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy testing project files and electronic database.
Monitor progress of upcoming and ongoing projects. Provide customers, and internal management with progress reports and/or status updates. Promptly identify issues or delays and work with affected personnel to resolve issues and communicate any changes in strategy or timelines.

Manufacturing Engineer,Medical Devices job – Katalyst HealthCares & Life Sciences – Raleigh, NC

March 2, 2018 – Manufacturing Engineer,Medical Devices – p b Job description: /b /p ul li This position is responsible for supporting process and system improvements in a high volume medical device

Medical Device Regulatory Consulting Services – Katalyst HLS

Medical Device Regulatory Services:
Pre-market approval – PMA.
Pre-market notification – PMN 510(k)
Investigational Device Exemption – IDE (for clinical studies)
Combination product (Drug/Device) Submissions
Establishment Registration and Device listing
Patent Registration
Strategy and Regulatory Agency meetings.