Job Summary

The manufacturing technician is responsible for providing production support by troubleshooting failed PC boards, maintaining test equipment and interfacing with the Engineering department on new designs. They will also assist in identifying areas of improvement and providing failure analysis in order to increase FPY metrics.

Primary Responsibilities:

• Product Technician
  • Provide guidance to other team members on troubleshooting devices and assemblies that fail testing
    • Troubleshoot products as needed down to the component level
    • Perform rework/repairs on products (SMT, through-hole, and technology down to 0201 package size and 0.50 mm pitch) to IPC-A610, Class 2.
    • Provide resolution of NCR action items
  • Maintain & continuously improve test yield
    • Collect and enter defects to provide historical data
    • Analyze defects to determine root cause and raise awareness of common defects
    • Work with other departments as required to improve test yield.
  • Sustaining Engineering Support
    • Maintain test equipment through the calibration and preventive maintenance program
    • Provide equipment and manufacturing support
    • Perform ESD audits and make corrections as needed
    • Support production lines to meet production schedule
  • New Product Introduction / Line Extension
    • Interface with the Engineering department on new designs.
    • Assist with the line set up in support of new product introduction or line extensions
  • Production Builds
    • May assemble, test and inspect product
  • Other duties as assigned.

Physical Requirements:

Ability to lift 40 lbs.

Minimum Qualifications:

Education:

• AA, AS degree in Electronics Engineering, technical school, or equivalent work/military experience

Experience:

• Soldering experience with IPC7711/7721 Standard knowledge a plus
• 3+ years working in electronics manufacturing facility
• Medical device manufacturing experience a plus but not required

Competencies:

• Ability to use electronic test equipment such as a DMM and oscilloscope
• Experience in the rework and repair of printed circuit boards, electronics manufacturing test environment, & component level troubleshooting
• Knowledge of reading schematics, production processes, and quality control operations is required
• Excellent communication skills, both written and verbal
• Microsoft Office: Word & Excel required and Power BI a plus

Please submit resumes to This email address is being protected from spambots. You need JavaScript enabled to view it.

Senior Systems Analyst - IT

Job Summary:

The Senior Systems Analyst is responsible for setting up and automating business and IT processes.  Works directly with users to understand problems and implement solutions following a change management process. Point of contact within a global IT team to provide remote as well as desk-side support. Responsible for IT Helpdesk and to process requests through the Incident Response system. 

To be successful in this role, you must have a high level of integrity, be team-oriented, proactive, have keen attention to detail, and have great customer service skills.

Primary Responsibilities:

• Performing analysis of root causes
• Act as the primary Subject Matter Expert (SME) for the SunTech Medical ERP solution globally
• Lead the design of internal database/data warehouse environments for SMI
• Perform a variety of complex programming/scripting tasks, such as designing, documenting, integrating local and cloud-based systems
• Assist engineers with designing SQL and users with BI data mining reports
• Develop, design, enhance, and administer Salesforce.com CRM
• Work with peers to provide technical training, guidance, and resource support for end-users and departmental staff
• Provide application support and enhancements to existing applications. Define system requirements, priorities, and viable alternatives. Coordinate the efforts of staff to locate, assess, install, test and maintain computer software systems. Coordinate conversions and upgrades to vendor systems (local and cloud)
• Evaluate reported incidents and provide triage or escalation services
• Effectively communicate to stakeholders during all phases of the incident response sequence – Incident submission to resolution
• Perform as a project lead and provide leadership and coordination on projects assigned to the IT organizations systems analysts.
• Work with peers to develop user documentation and departmental policies and procedures that impact the use of application systems.
• Administration of the VOIP system – Digium
• Administration of the Business Productivity Suite – MS Office 2016 / 365
• Administration of the Collaboration/Document Management solution – MS Sharepoint
• Administration of the Mobile Device Management console – Cisco Meraki
• Assist peers in the administration of the Global WLAN network – Cisco Meraki
• Administration of the CRM and ERP System – Salesforce.com, Kenandy
• Assist peers in the administration of the virtual computing/server environment
• PC configuration setup and deployment
• Perform other related duties as assigned

Physical Requirements:

Work is performed in a normal office environment.

Minimum Qualifications:

Requirements –

• Bachelor’s level degree in Computer Science, MIS or relevant field and 5+ years supporting a global IT infrastructure
• Microsoft Server 2008/2012
• Microsoft Windows 7/10
• Microsoft Office 2016/365
• Microsoft SQL
• Microsoft Sharepoint
• Salesforce.com

Preferred:

• Microsoft Active Directory
• VMware vSphere (or Citrix)
• Cisco Meraki (WLAN and Security Appliances)
• Cisco Meraki (MDM)
• Adobe Creative Cloud Administration
• ITIL v3 Certification
• ITIL v3 Practitioner
• Microsoft WDS
• Microsoft Deployment Toolkit Experience

Competencies:

• Salesforce.com (Administrator certification is a plus)
• Server and Desktop Virtualization
• Networking at a Net+ level (certification is a plus)
• Computer TS at an A+ level (certification is a plus)
• Current on INFOSEC best-practice methodologies
• Familiarity with Agile and Waterfall project management methodology
• Effective verbal and written communication
• Cloud architecture concepts Hosted/Private/Hybrid

Join Us!

Discover the benefits of working for a company that has been blazing the trail in blood pressure measurement technologies for more than 30 years. Together, we have a great future ahead of us.

Our employees are the key ingredient that allows us to create advances in our technology and innovate products that impact patient care. We also offer a competitive benefits package, to support the health and happiness of our team.

Please send resumes to This email address is being protected from spambots. You need JavaScript enabled to view it..

Job Summary: 

The incumbent will be responsible for maintaining and improving SunTech's Quality Management System and ensuring that SunTech's products meet the requirements of the US FDA, MDD and other regulatory agencies as required. 

SunTech is a US FDA registered establishment and its QMS is registered to ISO13485 with Intertek/Semko in addition to being registered with Japan, China, Canada and Brazil. In addition to the efficient operations throughout the company SunTech's QMS is essential for SunTech to continue shipping around the world. 

This position will be responsible for working with all departments and facilities to create regulatory documentation for all stages of medical device development, maintaining existing regulatory files, submitting 510(k)s to the FDA and working closely with SunTech's China facility to ensure that quality and regulatory policies are aligned. 

This position is also responsible for overseeing proper utilization of ComplianceQuest, an eQMS, that is just being integrated into the organization on the Salesforce platform. 

Skills 

• Leadership –Strong and effective leader and mentor of regulatory staff 
• Process development/improvement - strong aptitude for creating, standardizing and improving 
• Managing complexity - proven ability to organize complex registrations 
• Problem solving - collaboration with team members to identify root causes and creatively solve problems 
• Communication - excellent communication skills (presentation, written and verbal) 
• Change agility - ability to effectively change course in dynamic projects with changing scope standards and Regulations - well-versed in the EU Medical Device Directive, ISO standards and 21 CFR 820 

Responsibilities include but are not limited to: 

• Manage QA/RA team who oversee all aspects of SunTech's quality management systems, ensuring compliance with all ISO13485, FDA and other regulatory and governmental requirements as required. 
• Manage all aspects of SunTech's worldwide regulatory affairs, ensuring compliance with all applicable CE, FDA, CFDA, ISO and other governmental approvals with respect to all SunTech products. 
• Champion SunTech’s quality policy and mission of continual improvement. 
• Continually assess, track and provide monthly updates to the CEO on key metrics relating to quality, regulatory and customer service functions. 

Page 2 of 2 

• Perform internal and external audits of SunTech’s processes, procedures and key suppliers. 
• In conjunction with other departments, assess suitable new suppliers and maintain regular supplier audits. 
• Ensure compliance with all legal and other directives in so far as they relate to the sales of SunTech’s products worldwide. 
• Review and approve SunTech's labeling and ensure that it complies with domestic and international standards. 
• Provide customer support on regulatory issues; 
• Manage technical aspects of quality issues and problems; 
• Develop and maintains product technical construction files; 
• Develops 510K submissions and obtains FDA approval; 
• Support product registrations for many countries on a worldwide basis; 
• Provide project leadership for needed updates to existing products caused by new/revised standards; 
• Support worldwide regulatory compliance of SunTech products and/or services, including RoHS, REACH and Risk Management; 
• Work closely with other departments, especially Engineering, to ensure new products are in compliance with published standards; 
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.; 
• Conduct training and/or communicate appropriate material to internal staff to aid in compliance; 
• Assist in developing regulatory affairs internal policies and procedures, and provide compliance training; 
• Other duties as assigned. 

Physical Requirements: 

• Work is performed in a normal office environment; 
• 0-15% travel; Must be able to travel to China 

Minimum Qualifications: 

Education - B.S. degree in Engineering is preferred 

Experience – 

• 10+ years of prior Quality and Regulatory experience 
• 5+ years of medical device, biomed or pharma experience 
• 5+ years of management or supervisory experience 

Competencies: 

• Extensive knowledge of medical device regulations and standards. (e.g. FDA, MDD, ISO 9001, ISO 13485, etc.); 
• IEC60601-1 3rd addition; 
• RoHS/REACH experience preferred; 
• Product registration knowledge and experience on a worldwide basis; 
• Excellent organizational and multi tasking skills; 
• Ability to work under pressure with strict deadlines; 
• Detail-oriented; 
• Good presentation skills; 
• Proficient with MS Office, including MS Word, Excel, PowerPoint and MS Project. 

Please email your resume and cover letter to This email address is being protected from spambots. You need JavaScript enabled to view it.

Job Summary:

We are looking for an experienced Product Engineer with a strong personal initiative, an intense eye for quality and detail, and a passion for excellence who enjoys working in a fast-paced, collaborative manufacturing environment. This position will be responsible for SunTech Medical’s Stress, Vitals, and Ambulatory Blood Pressure Monitor (ABPM) product lines from the specification phase, through development, into production and customer support. This position will also support initiatives with SunTech’s OEM blood pressure products.  The ideal candidate will have a strong technical background plus excellent interpersonal skills.  The incumbent will work closely with multiple departments including engineering, sales, marketing, regulatory, manufacturing, and outside contractors.

Primary Responsibilities:

• Support new product development activities from design win through final production
• Write functional specifications, firmware validations/verifications, and test plans
• Occasionally lead projects as project manager. This includes developing and maintaining work breakdown structures, Gantt charts, project binders, project costs and leading phase reviews
• Serve as project engineer including developing specifications, verifying designs, writing design and production test plans, and validation work
• Lead and participate in CAPA investigations using failure analysis and effective corrective action processes to resolve product issues
• Work closely with manufacturing for introduction of new products and ongoing manufacturing support
• Identify and qualify new product components due to EOL, cost reductions, availability, etc.
• Understand regulatory requirements and ensure products meet relevant requirements
• Release and maintain engineering documentation
• Coordinate validation, regulatory, and performance testing activities
• Support the sales force throughout the world
• Other duties as required

Physical Requirements:

• Work is performed in a normal office environment
• Ability to lift up to 20lbs.
• This position may require up to 10% travel (domestic and international)

Education and Experience:

• BS in Electrical Engineering, or equivalent
• 4 + years engineering experience
• Customer support experience a plus
• Medical Device Industry experience a plus

Competencies: 

• Experience with hardware, software, and mechanical design
• Excellent oral and written communication skills
• Detail oriented and highly organized
• Exceptional multi-tasking, prioritizing and problem-solving skills

Proficiency in Microsoft programs - Word, Excel, Outlook, PowerPoint, MS Project 

Send Resumes to This email address is being protected from spambots. You need JavaScript enabled to view it.