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Senior Post Market Engineer

Katalyst Healthcares and Lifesciences

Gainesville, Florida, USA

Full-time

Roles & Responsibilities: Bachelor's Degree in an Engineering discipline from an accredited institution required. Complaint product analysis and testing per procedures and requirements. Root cause analysis and supports conclusions with objective evidence and sound rationale. Complaint risk analysis and complaint history reviews. Knows and applies Quality System requirements and any appropriate FDA and international standards. Must have an understanding of root cause and risk analysis as wel

Electrical Engineer

Innova Solutions, Inc

Lake Forest, California, USA

Contract, Third Party

A client of Innova Solutions is looking for an Electrical Safety Engineer Position type: Contract Duration: 12+ Months Location: Lake Forest, CA (Onsite) As an Electrical Safety Engineer, you will: Minimum Qualifications: Electrical Engineering (or similar) with experience in medical device safety compliance .Expert knowledge of IEC 60601-1 for medical electrical equipment.familiar with FDA Approval processProven experience working cross-functionally with R&D teams and external labs for safety

Product Cybersecurity Engineer

Sureminds Solutions

Danvers, Massachusetts, USA

Contract

Please share Profiles at Hi, Urgent need, Title: . Product Security Engineer- Location : Danvers, MA ( day 1 onsite) Note- Cybersecurity experience in medical device / domain is mandatory Job description 5+ years industry experience in Information Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR). Experience with security risk management techniques. Demonstrated organizational skills, attention to deta

Technical Project Manager

TEKsystems c/o Allegis Group

Alameda, California, USA

Full-time

Looking for Technical Project Manager with experience in Engineering or Project Management within the medical device industry. As well as having a understanding of ISO and FDA guidelines for medical device product development. Responsibilities: Design, communicate, and implement an operational plan for completing a project; monitor progress and performance against the project plan; resolve operational problems, minimize delays. Identify, develop, and gather necessary resources to complete the pr

Engineer II

Katalyst Healthcares and Lifesciences

West Point, Pennsylvania, USA

Full-time

Responsibilities: The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints - including ensuring the root cause appropriately. Consider the device and device constituents, author technical and risk assessments related to the device design change, and document the device risk analysis from complaints. Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes

Engineering Technician

Katalyst Healthcares and Lifesciences

Sumter, South Carolina, USA

Full-time

Job Description: Performs any combination of tasks involved in the fabrication, manufacture, assembly, testing and packaging of medical devices as well as setting up, operating, performing maintenance on and troubleshooting equipment. May conduct quality inspections on processing line in accordance with quality specifications. Works within clearly defined SOPs and / or scientific methods and adheres to quality guidelines. Requirements: High school diploma or equivalent. More than two years of

Software Engineer IV

OnPoint Surgical, Inc.

Concord, Massachusetts, USA

Full-time

The Software Engineer will develop medical device software for surgical planning and intra-operative guidance of spinal procedures, including spinal fusion, as part of a computer-aided surgery system for medical device start-up. They should possess expert-level proficiency in C# and have a deep understanding of software engineering principles, including object-oriented design, data structures, algorithms, and software architecture. As well as skilled in developing and debugging software that in

Product Manager

Motion Recruitment Partners, LLC

Massachusetts, USA

Full-time

A medical devices manufacturer and distributor in Marlborough is looking for talented Product Managers to join their team. They recently launched a novel FDA approved medical device that is being used to treat impulse control, addiction, and depression. This product has the potential to be revolutionary in the mental wellness space. They are looking for Product Managers who hav a strong background in medical device product management with a background either in biology or biomechanical engineer

Technical Writer - Product Labeling

bioMerieux

Hazelwood, Missouri, USA

Full-time

Position Summary & Responsibilities: The Technical Writer is responsible for the development, revision, and control of product labeling deliverables (user manuals, instructions for use, and labels) in a Content Management System. This role supports reagents, accessories, and software both during the product 98development process and Lifecyle Management. During this process, the Technical Writer will write/update, review, and finalize labeling deliverable according to regulatory standards and re

Business Development Manager, EMS

East West Manufacturing

Remote

Full-time

Business Development Manager Calling all creatives, solvers, analysts, planners, doers, and visionaries! East West is seeking a talented and experienced Business Development Manager to join our dynamic sales team. Our vision is to make the world a better place cleaner, safer, healthier, and smarter. We are looking for someone who shares our passion and is eager to contribute to our mission. JOB SUMMARY: The Business Development Manager serves as the commercial lead for East West, primarily focus

Data Analyst

Talent Software Services, Inc

Arden Hills, Minnesota, USA

Contract

Data Analyst IJob Summary: Talent Software Services is in search of a Data Analyst for a contract position in Arden Hill, MN. The opportunity will be six months with a strong chance for a long-term extension.Position Summary: Prepares analytics and insights across the department as well as provides operational efficiency and optimization within the department.Primary Responsibilities/Accountabilities: Communicates and supports the Data Analytics strategy. Determines customer requirements and tra

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Albany, Georgia, USA

Full-time

Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology transfers. Lead comprehensive IQ/OQ/PQ validation activities across multiple projects. Create robust standard operating procedures for manufacturing excellence. Ensure continuous process verification for robust manufacturing operations. Coordinate cross-fu

Enterprise Solutions Architect || pharma experience is must in GXP environment || Remote

ARK Infotech Spectrum

Remote or Pittsburgh, Pennsylvania, USA

Third Party, Contract

Position: Enterprise Solutions Architect Location: Pittsburgh, PA || Remote || Note : pharma exp is must in GXP environment. Description The PSG IT Enterprise Solutions Architect is a technology and architecture leader with broad knowledge of systems, services, software architectural concepts and system integration patterns. In this role, the IT Enterprise Solutions Architect, is part of the Pharma Services Group. The IT Enterprise Solutions Architect works with Enterprise, Group, and Division I

Sr Validation Engineer

Katalyst Healthcares and Lifesciences

Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute

Controls Engineer

Jobot

Hartford, Wisconsin, USA

Full-time

Controls Engineer - Turnkey Automation Systems - Direct Hire This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $65,000 - $130,000 per year A bit about us: Our customer is a leading industrial automation provider. They have about 125 employees and have all facets of engineering on-site such as Mechanical, Controls, Software, Applications and Project. They are looking for a strong Controls Engineer to j

Controls Engineer

Jobot

Pewaukee, Wisconsin, USA

Full-time

Controls Engineer - Turnkey Automation Systems - Direct Hire This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $65,000 - $130,000 per year A bit about us: Our customer is a leading industrial automation provider. They have about 125 employees and have all facets of engineering on-site such as Mechanical, Controls, Software, Applications and Project. They are looking for a strong Controls Engineer to j

Controls Engineer

Jobot

Milwaukee, Wisconsin, USA

Full-time

Controls Engineer - Turnkey Automation Systems - Direct Hire This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $65,000 - $130,000 per year A bit about us: Our customer is a leading industrial automation provider. They have about 125 employees and have all facets of engineering on-site such as Mechanical, Controls, Software, Applications and Project. They are looking for a strong Controls Engineer to j

Electrical Engineer Device Tester

VKore Solutions LLC

California, USA

Third Party, Contract

Hi, Hope you are doing well. This is Sonu from Vkore solutions. Below is the active requirement I am having. Kindly go through it and share your consultants at You can reach me at +1 1 . LinkedIn: Please find the job description below and let me know if you are interested: Role:- Electrical Tester Location- Lake Forest CA Must: Medical Device Testing Key Responsibilities: Perform electrical testing and validation on circuits, systems, and components. Conduct functional, performance, and re

Sr. Quality Assurance Manager - Manufacturing/Med Device

Zachary Piper Solutions, LLC

Chelmsford, Massachusetts, USA

Full-time

Piper Companies is hiring a Senior Manager of Quality Assurance (Manufacturing/Medical Device) for a medical device company located in Chelmsford, MA. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will oversee QA Operations, derive continuous improvement initiatives and foster a culture of quality across the organization. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will need to work onsite 5 days per week in Chelmsford, MA. Responsibilities fo

Automation Engineer

Katalyst Healthcares and Lifesciences

Keene, New Hampshire, USA

Full-time

Responsibilities: Support design reviews, debug, acceptance and validation activities for equipment being developed by external suppliers. Support decommissioning and recommissioning of equipment. Fundamental knowledge of statistical analysis - specifically GR&Rs & Process Capability. Experience with Allen-Bradley/Rockwell Automation programming, Studio5000, RSView ME/SE, Siemens S7 programming, Staubli/EPSON/ABB robot.Requirements: 4+ years' experience in a medical device manufacturing enviro