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The Senior Director, Systems Engineering will be responsible for leading the instrument engineering teams to drive new hardware design and development, critical reliability activities, troubleshooting, testing, and technical support for this novel diagnostic platform. The successful candidate must possess advanced knowledge in a particular field of engineering and have experience driving the completion of projects of high complexity, ideally in FDA regulated environments. To succeed, the candidate must have well developed leadership qualities and exhibit creativity, foresight, and excellent judgement. The candidate must have excellent organizational skills, including the ability to evaluate, prioritize, and handle multiple subprojects and priorities. Must be able to collate, analyze, and draw conclusions from data generated from multiple sources in order to prioritize design improvements, drive corrective actions, and support stakeholders. The candidate must have a hands-on approach, including getting in the lab to troubleshoot and assist as may be needed.
This role will report directly to the Chief Product Officer (CPO).
To find out more about Real please visit http://www.realstaffing.com
Skills & requirements
-8+ years of experience with 3+ years of experience managing engineering/technical teams. -Five or more years of experience in regulated medical device dev -Exp. with successful IVD system development
Daily Duties:
- Lead projects focused on medical device governance, risk and compliance.
- Hands on system selection, acquisition, specification, configuration, design assurance, implementation etc.
- Technical evaluations of enterprise level (non-product) systems such as embedded devices, applications, middleware, databases, infrastructure and IT networks
- Lead requirement elicitation and detailed design discussions across several business units (developers, analysts, R&D, quality/regulatory etc)
Must Have Requirements:
- At least 5 years experience with Non-Product Software Validation
- Experience with regulatory compliance or FDA regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971)
- Experience with guidance such as NIST, IEC, GAMP, GDPR or Data Integrity
- Experience designing and performing quality and compliance risk assessments
- Experience with software development methods (SDLC)
- Bachelors degree in engineering, science or a similar discipline
- US Citizenship required
Additional Qualifications:
- Experience working in a manufacturing, business or a laboratory environment
- Knowledge of security-by-design, change management, contingency planning, disaster recovery
- Certifications a plus: CISA, CRISC, CGEIT, CISSP, GSSP, CSSLP, SSCP, CPP, CSQE, CQA
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
Non-Product Software Validation experience within the medical device or FDA regulated industry.
The Business Systems Analyst will join the academic information systems team to assist with various web application development projects. They will help primarily with software development lifecycle tasks such as communicating requirements to team and staff.
Must Have Requirements:
- At least 3 years of experience writing software/technical specifications
- Experience gathering business requirements
- Experience working in agile environments
Additional Requirements:
- Experience working within Health Care, Administrative, Education or Web Applications
- Able to communicate effectively with both technical and non-technical partners
- Can work cross-functionally with teams and high level stake holders
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
At least 3 years of experience writing software/technical specifications
Provides technical leadership to small or medium sized project teams to ensure interdisciplinary integration is met. This position is responsible for considering the complete problem across the entire life cycle of the product.
Scope of Responsibilities:
* Defining customer needs and required product functionality.
* Documenting product requirements and project constraints.
* Leading, guiding, and/or performing the technical product development for the system or subsystem being developed-providing and supporting the big picture systems view. This includes tracking key technical metrics to measure margins and risk.
* Overseeing and leading verification and validation planning, execution, and reporting efforts.
* Navigating or supporting the team and the product through regulatory compliance activities.
* Ensuring efficient and complete transition from design into production.
* Prepares and presents documentation to clients and stakeholders.
This position is also tasked with supporting our business development efforts including writing proposals, planning technical aspects of projects, developing our capabilities, interfacing with current and prospective clients, and participating in conferences.
The Following is Required
* Bachelor's Degree in engineering discipline relevant to product development.
* 5+ years of experience in new product development roles, 3+ years of systems engineering experience
* Demonstrated track record of successful product development on complex projects.
* Proven abilities in leading cross functional technical teams, managing risk, and adapting to change.
* Self-motivated, organized, and a problem solver who demonstrates knowledge of fundamentals but also the big picture.
* Excellent communication skills to support interaction with cross-functional team members, internal management, and clients.
Sthree US is acting as an Employment Business in relation to this vacancy.
Position: Product Customer Support Specialist
Location: Warsaw, IN - open to remote candidates
Contract Length: Through 2021, and renew afterwards
Rate: Based on experience
Specific Job Responsibilities:
- Serve as first point of contact on solution-specific inquiries by utilizing product documents. Become familiar with company web sites and applications available for health care professionals and patients.
- Process new customer registrations and update/maintain existing customer portals
- Organize and keep track of a large number of documents for each customer.Direct collaboration with all internal production departments, development engineers and marketing managers.
- Provide web and mobile application navigational support for customers and patients.
Job Skills/Requirements
- Minimum of 3 yearsin customer-facing role (External and internal).
- Bachelor's degree required.
- Experience and/or managing customer phone calls, emails, including technical support.
- Ability to take initiative to improve processes and work with limited supervision.
- Strong verbal and written communication skills.
- Analytical and active listening skills that will lead to correct pathways to solve problems and offer solutions.
- Strong interpersonal skills with experience working in team-oriented project groups.
- Maintain a schedule of deadlines and tasks and possess the ability to prioritize effectively.
- Experience with Customer Relationship Management (CRM) software and tools preferred.
- Demonstrates high level of competency with Excel, Word, Outlook, Access, TEAMS, and PowerPoint
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
3+ years in customer-facing role (external and internal) Bachelor's degree is required Strong verbal and written communication skills Experience with CRM tools and software preferred
Position: Product Customer Support Specialist
Location: Warsaw, IN - open to remote candidates
Contract Length: Through 2021, and renew afterwards
Rate: Based on experience
Specific Job Responsibilities:
- Serve as first point of contact on solution-specific inquiries by utilizing product documents. Become familiar with company web sites and applications available for health care professionals and patients.
- Process new customer registrations and update/maintain existing customer portals
- Organize and keep track of a large number of documents for each customer.Direct collaboration with all internal production departments, development engineers and marketing managers.
- Provide web and mobile application navigational support for customers and patients.
Job Skills/Requirements
- Minimum of 3 yearsin customer-facing role (External and internal).
- Bachelor's degree required.
- Experience and/or managing customer phone calls, emails, including technical support.
- Ability to take initiative to improve processes and work with limited supervision.
- Strong verbal and written communication skills.
- Analytical and active listening skills that will lead to correct pathways to solve problems and offer solutions.
- Strong interpersonal skills with experience working in team-oriented project groups.
- Maintain a schedule of deadlines and tasks and possess the ability to prioritize effectively.
- Experience with Customer Relationship Management (CRM) software and tools preferred.
- Demonstrates high level of competency with Excel, Word, Outlook, Access, TEAMS, and PowerPoint
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
3+ years in customer-facing role (external and internal) Bachelor's degree is required Strong verbal and written communication skills Experience with CRM tools and software preferred
The VELYS Product Specialist is an essential member of the VELYS Digital Surgery platform. The product specialist serves as a primary point of contact for healthcare professionals and patients. This position requires a high level of professionalism and dedication to meeting all stakeholders' requests promptly and accurately in a fast-paced setting.
Specific job responsibilities include:
- Serve as first point of contact on solution-specific inquiries by utilizing product documents. Become familiar with company web sites and applications available for health care professionals and patients.
- Perform coordination and tracking duties on solution startups and development. These duties include but are not limited to: Handling customer inquiries, training customers on the solution, partnering with research and development teams to prioritize account specifics item creation, generating status reports, and performing transactions in cloud-based case management system to ensure production milestones are achieved.
- Educate health care professionals and patients about solution offerings and troubleshoot technical challenges in navigating customer web portals.
- Conduct demonstrations and trainings with healthcare professionals.
- Process new customer registrations and update/maintain existing customer portals.
- Provide web and mobile application navigational support for customers and patients.
- Direct collaboration with all internal production departments, development engineers and marketing managers.
- Serve as liaison between the customer and development team to ensure solution items are received in the proper format.
- Organize and keep track of a large number of documents for each customer.
Job Skills/Requirements:
- Minimum of 3 years in customer-facing role (External and internal).
- Bachelor's degree required.
- Experience and/or managing customer phone calls, emails, including technical support.
- Ability to take initiative to improve processes and work with limited supervision.
- Strong verbal and written communication skills.
- Analytical and active listening skills that will lead to correct pathways to solve problems and offer solutions.
- Strong interpersonal skills with experience working in team-oriented project groups.
- Maintain a schedule of deadlines and tasks and possess the ability to prioritize effectively.
- Experience with Customer Relationship Management (CRM) software and tools preferred.
- Demonstrates high level of competency with Excel, Word, Outlook, Access, TEAMS, and PowerPoint
Sthree US is acting as an Employment Business in relation to this vacancy.
Our client is a top company in the Medical Device space. Considering innovation is a key component of their business, they channel significant resources and attention into Technology.
They are looking to fill an important role on their Software Engineering team. This is a 12-month contract, with potential to renew or convert.
Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develops, enhances, maintains, and debugs low-level software for communicating with hardware in medical devices products.
- Reads and implements the design specifications.
- Works with cross functional team of engineers, program managers, system engineers, and software test team members.
QUALIFICATIONS AND SKILLS:
- Must have prior experience developing commercial embedded software applications in C/C++.
- Strong understanding of the SFDC.
- Experience with communication data protocols and interfaces.
- Familiarity with USB data analyzer, oscilloscope, multimeter tools and ability to read PCB / circuit design documents is a plus.
- Must possess excellent oral and written communication skills in English language.
- Works independently, is self-motivated and able to complete tasks with minimal supervision.
Sthree US is acting as an Employment Business in relation to this vacancy.
The Embedded Software Engineer will help work on a respiratory monitoring device. This person will collaborate with other teams on both the software and hardware side to code and test embedded concepts.
This is a long term contract for a minimum of 1 year and likely to go up to 2-3 years and transition into additional projects.
Daily Duties:
- Design, Implement and test software in embedded devices
- Integration, debugging and documentation
- Research and evaluate various software solutions
- Work cross-functionally between teams to fit project schedules and timelines
Job Requirements:
- Ideally this person will have around 5 years of experience
- C++ programming experience
- Experience working with ARM based processors
- Knowledge of bare-metal, real-time hardware environment
- Experience working in an FDA regulated industry
- Great communication
Additional Nice to Have Skills:
- Bachelors degree in computer science or engineering
- ST Micro experience
- Med Device experience
- Exposure to configuration management tools
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
5 or more years experience as an Embedded Software Engineer C++ Programming Knowledge Experience using ARM based processors Experience working with bare-metal or real-time environments (hardware)
My client is searching for an experienced Process Engineer who can analyze business methods and find efficient alternatives. The Process Engineer will be responsible for delivering regular recommendations on how to maintain staff levels and lower costs, while meeting all of the quality standards set forth by the company and government regulations. The successful candidate will work side-by-side with the management staff to discover inefficiencies in business processes and then determine the best ways to bring our business methods in line with our financial goals.
Process Engineer responsibilities
- Analyze work flows within and across all departments to determine how the entire company can work better together
- Review the KPI monitoring systems and determine ways to improve their ability to maintain company operations
- Create an analytical process that justifies business decisions
- Analyze capital expenditures and project designs to help find ways to cut costs
- Maintain an updated outlook on all associated business costs and deliver a quarterly report on pertinent industry trends to the management team
Process Engineer skills
- Bachelor's Degree in Engineering or related discipline required (Master's preferred)
- 5+ years in quality or business process engineering
- Impeccable math and statistical analysis skills
- Excellent eye for detail
- Proven history in improving supply chain efficiency
- Must be comfortable with integrating new technology into an existing business environment
Sthree US is acting as an Employment Business in relation to this vacancy.
Image Data Engineer
Daily Duties:
- You will be responsible for all data flow activities
- Retrieve clinical data (images) from sources and work with all teams to curate, organize and prepare
- Lead data integration efforts between internal and external partners
- Maintain solutions for data management, governance, provisioning, QC and visalization using databases, file systems and cloud platforms
- Automating workflows and processes
- Support ML/DL algorithms and pipelines
- Work cross functionally between teams and stakeholders to report imaging assets
Must Have Skills:
- Experience working with clinical image data - making annotations, integrating to visualization and analytical tools
- Experience with data warehousing, data profiling
- Experience with SQL (relational database queries)
- Experience with one or more scripting languages (python, Matlab, Shell)
- Experience with medical imaging formats (DICOM, nifti)
Preferred Additional Skills:
- Knowledge of clinical trials
- Experience with ML/DL
- Experience with REST APIs, Linux environment
- Experience with AWS
- Experience working in multiple therapeutic areas around clinical imaging
- Great communication and presentation skills
Education
Bachelor's degree in Computer Science, Biomedical Engineering, or a similar discipline; Master of Science preferred
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
-Proven experience with data warehousing, data ingestion, and data profiling. -Proficiency with relational database queries (SQL), pivoting data, and working with clinical data standards
One of our largest medical device clients in the Midwest is currently looking for a Senior Quality/Validation Engineer:
- Responsible for writing/contributing to, and reviewing Process risk assessment documents & Process validation documents
- Responsible for writing and executing Test Methods and Test Method Validations, as well as Manufacturing Control Plans.
- Must have Medical Device experience and process knowledge (machining, polishing, blasting, packaging)
- Engineering degree required, Excellent technical writing skills / GDP knowledge
- Must have process risk assessment experience
- 5+ years of quality experience preferred
- Previous medical device experience preferred
Sthree US is acting as an Employment Business in relation to this vacancy.
Skills & requirements
Experience with Process Risk Documentation 5+ years of quality experience Experience with medical devices Experience with TMV Manufacturing control plans Process Validation