SkionTek

Careers

Place where skills & Passion meets to satisfy everyone’s need and deliver better solution.

1) Design Engineer

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Responsibilities

Drives mechanical product design quality, reliability, and compliance to standards and regulations
Leads and supports on-time completion of design control deliverables
Critically evaluates mechanical product designs, identifies potential design quality issues, and drives issue resolution
Leads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization
Leads DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Supports quality system development and improvements
Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Supports design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations
Supports and ensures on-time execution of Quality Plans for OEM manufacturing for development projects and design changes
Supports manufacturing process development & qualification for new product commercialization and product changes
Supports significant investigations related to product quality for commercial products
Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

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Requirements

Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
3+ years relevant experience within the medical device industry or related function
Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred
Strong statistical data analysis skills
Design for Six Sigma and Critical to Quality training and experience a plus
Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
Excellent verbal and written communication skills
Experience partnering with external entities (customers and suppliers) to complete projects preferred

2) Quality Engineer

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Responsibilities

Responsible for designing, developing, and implementing components used for the packaging of incoming raw materials, final product, and product shipments
Responsible for the design and coordination of qualification and distribution testing per ISO11607
Prepare product for required ISO 11607 studies including stability, distribution, sterility, biocompatibility, endotoxin and temperature-controlled shipping systems
Work with Suppliers to develop and write specifications for purchase and approval of all packaging components to ensure uniformity and compliance of components.
Develop package components and packaging systems that best meet the needs of internal/external customers to support strategic business needs for growth, quality, and productivity
Responsible for creating, reviewing, and approving protocols for package design, packaging process validation, and package shelf-life testing in accordance with internal procedures and industry guidelines
Develop and execute test methods, validations, and protocols for packaging related developments and projects to ensure we meet all necessary safety, quality and density
Review quality issues, by inspecting products, components, procedures for new product development and delivery
Responsible for documentation of IQ, OQ, PQ, control and inspection plans of packaging
Ensure compliance with EN ISO 14971 and ISO 13485 regulations for risk management deliverable documents and develop Risk Management File per ISO 14971 including Risk Management Plan, Design FMEA, Process FMEA, Risk Analysis,
Riskmanagement Report to synchronize with Design Control Documents
Implement ISO 13485, FDA quality system regulations, ISO 14971 for design and risk management
Experience in statistical data analysis and measurement system analysis (MSA) using Minitab (Gage R&R)

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Requirements

Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
3+ years relevant experience within the medical device industry or related function
Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred
Strong statistical data analysis skills
Design for Six Sigma and Critical to Quality training and experience a plus
Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
Excellent verbal and written communication skills
Experience partnering with external entities (customers and suppliers) to complete projects preferred

3) SR. Java Developer

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Key Skills

Proven hands-on experience in Java 8 (and above), J2EE, Spring Framework, web services, micro services (REST), hibernate.
Should be good experience in no sql database or unit test/smoke testing
Hands on experience on AWS, No SQL DB and API or Kafka experience.
Proven hands-on experience in JavaScript, HTML/CSS. and in Java Script /Angular/JQuery
Must have hands-on experience in Java technologies – JSP, EJB, JMS, Spring, Spring Boot, Transfer protocols – (SFTP, HTML, XML), RESTful Services /APIs (REST and SOAP)
Hands on Kafka and any no-sql databases like Cassandra
Understanding of Docker, Kubernates concepts
Mainly – candidate should have worked on/have good knowledge of Payments
Experience working on mission critical high-performance platforms which have low latency/response times
Experience in fine tuning application response / performance testing. Experience in using tools like JMeter/JProbe etc.
Excellent communication skills – both verbal and written
Ability to work independently with limited supervision

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Requirements

Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
3+ years relevant experience within the medical device industry or related function
Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred
Strong statistical data analysis skills
Design for Six Sigma and Critical to Quality training and experience a plus
Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
Excellent verbal and written communication skills
Experience partnering with external entities (customers and suppliers) to complete projects preferred

4) Infrastructure Engineer

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Key Skills

Proven hands-on experience in Java 8 (and above), J2EE, Spring Framework, web services, micro services (REST), hibernate.
Should be good experience in no sql database or unit test/smoke testing
Hands on experience on AWS, No SQL DB and API or Kafka experience.
Proven hands-on experience in JavaScript, HTML/CSS. and in Java Script /Angular/JQuery
Must have hands-on experience in Java technologies – JSP, EJB, JMS, Spring, Spring Boot, Transfer protocols – (SFTP, HTML, XML), RESTful Services /APIs (REST and SOAP)
Hands on Kafka and any no-sql databases like Cassandra
Understanding of Docker, Kubernates concepts
Mainly – candidate should have worked on/have good knowledge of Payments
Experience working on mission critical high-performance platforms which have low latency/response times
Experience in fine tuning application response / performance testing. Experience in using tools like JMeter/JProbe etc.
Excellent communication skills – both verbal and written
Ability to work independently with limited supervision

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Requirements

Bachelor’s Degree in a Technical Field
5+ years of experience with Linux Server administration, hardware, virtualization, and support
3+ years of designing and implementing new infrastructure systems and solutions
Experience implementing technologies with enterprise-wide impact
Extensive experience with automation of infrastructure as code using Ansible/Terraform/ARM
Proficient in scripting using PowerShell/Python
Proven experience with managing and utilizing cloud infrastructure
Knowledge of basic Technologies such as Firewalls, Load balancing, REST API, Databases etc.
Strong analytical, problem-solving, and troubleshooting skills, with the ability to quickly identify and resolve issues
Experience with CI/CD tools, preferably Azure DevOps
Ability to communicate effectively with peers, users, and all management levels