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We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Guidance by the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA

We are looking for an R&D Technician to join our top-talented multidisciplinary R&D team. The ideal candidate should be striving for the challenge of making a significant impact in a multi-disciplinary product in the med-tech industry; hands-on and highly technical.
The R&D Technician will provide diagnosis and analysis of all development aspects including solving technical problems.
Key Responsibilities:
Perform tests and Research (using JIGs, Apps, and specially designed tools).
Conducting electro-mechanical experiments for research, development, and validation.
Perform routine chemistry laboratory duties, such as weighing, and evaporating.
Working closely with the test and development teams.
Reading and writing reports related to R&D or testing.

We are looking for a Site Reliability Engineer.
Responsibilities:
Improving the availability, performance, and security of production services.
Mitigating issues on production systems and building solutions through automation to prevent issues from reoccurring.
Automating common, repeatable tasks using Ansible and scripting languages (Python/Bash).
Triaging and managing the escalation of cases and managing monitoring for services.
Influencing the design/architecture of new services to proactively prevent system failures.
Management of the on-premise server's lifecycle (continuous deployment, upgrades, provisioning) and customer deployment.
Creating alerts and tools to monitor service health and performance (Python/Elastic).

We are looking for a Senior PMO to join our team.
As a Cross-Company PMO, you will play a critical role in ensuring efficient project management practices across various teams and departments. You will be responsible for establishing and maintaining project management standards, processes, and methodologies to drive successful project execution. Your role will involve collaboration with different stakeholders, including project managers, department heads, and executives, to align project objectives with overall business goals.
This position offers an exciting opportunity to contribute to the growth and success of our dynamic company.
You are expected to:
Establish and Maintain PMO Framework: Develop and implement project management processes, procedures, and best practices tailored to the needs of our scaling company
Hands on Project Management of selected cross-departmental projects
Project Governance and Oversight: Provide governance and oversight across strategic projects, ensuring alignment with strategic objectives, timelines, and budgets. Establish project governance structures, including project charters, steering committees, and regular project status reporting mechanisms.
Risk Management and Mitigation: - Identify project risks and develop strategies for mitigation and contingency planning. - Implement risk management processes to proactively address potential issues and minimize project disruptions.
Performance Monitoring and Reporting:- define key performance indicators (KPIs) and metrics to measure performance and success.
Stakeholder Communication and Collaboration: facilitate communication and collaboration among project stakeholders, ensuring alignment on project objectives, requirements, and priorities.
Continuous Improvement: drive continuous improvement initiatives within the PMO to enhance project management capabilities and deliver greater value to the organization.

We are seeking a skilled and experienced Thermal Analysis Engineer to join our dynamic team focused on developing cutting-edge sensor and laser-based products. In this role, you will play a critical part in ensuring the thermal performance, reliability, and efficiency of our products. Your expertise in heat transfer, thermodynamics, and thermal simulation will be instrumental in guiding the design and optimization of thermal management solutions.
Your Day to Day:
Create and develop accurate thermal models using dedicated software (e.g., ANSYS Fluent, COMSOL, etc.)
Analyse and predict thermal behaviour under various operating conditions, including power levels and environmental factors
Design and optimise cooling solutions, such as TECs, heat sinks, fans, and thermal interface materials, to maintain optimal operating temperatures for laser/optical components
Collaborate with the mechanical engineering team to integrate thermal solutions into product designs seamlessly
Conduct thermal testing and validation experiments to verify the performance of selected materials and thermal management solutions
Present findings and recommendations while maintaining documentation of thermal analyses, simulations, and testing procedures.

We are looking for some exceptional talent to join our team as a Mechanical Engineer.
You will be part of a growing team designing and developing SWIR perception systems to meet worldwide customer requirements.
Your Day to Day:
Responsibility for an end-to-end mechanical and optomechanical design, development, and manufacturing of an electro-optical sensing system, incorporating laser sources, sensors, optics, electrical hardware, and thermal modules
Full ownership of the mechanical solution including design, analysis, reviews, drawings, manufacturing, assembly support, tests, and experiments
Develop electro-optical-mechanical packaging concepts
Initiate and lead the implementation of thermal solutions to different heat dissipation challenges (in-house and contractors)
Design jigs and develop tools to support different R&D efforts
Collaborate with various R&D disciplines (including Electro-Optics, Photonics, Electronics, and System Architecture) to jointly develop a product that aligns with system requirements.