Jobs Opening

PFEP database Developer
 This is a entry level position. 1 year experience is enough
JD below
Developing PFEP database using Oracle JD Edwards to implement lean material handling system, design warehouse & supermarket rack map to improve material handling efficiency, support 5S activities through relabeling POU & supermarket bins using color codes, and other needed IE support activities.
-He will work with other continuous improvement activates
Apply Now
Project Manager PLM
  • Lead and manage resources and ensure optimum resource utilization and high customer satisfaction 
  • Meeting correlation 
  • Action items follow up 
  • Detailed schedule creation and tracking. 
  • Schedule correlation with other stakeholders 
  • Support customer PM for any task 
  • Vendor activities follow up 
  • Overall project management 
Experienced in large scale project management, PMP certification must 
Apply Now
Teamcenter Business Analyst/Architect
Position: Teamcenter Business Analyst/Architect
Location:  Remote 
Participate in aPLM Project 
·  Day To Day Activities include but not limited to 
  • Participate / Conduct discussion with Business Users 
  • Draft Business requirements 
  • Able to architect solution in Teamcenter 
  • Convince users / and stakeholders for best design and technical solution 
  • Guide development team on design implementation 
  • Enable team building and delivery 
  • Coordinate with required stakeholders 
  • Maintain backlog, and prioritize along with Product Owners 
  • Thorough Teamcenter knowledge. 
Apply Now
Mobile Automation Engineer.
  • BS/MS in Computer Science  or Electronics and Communication Engineering 
  • Must Have – Strong Programming Experience in Java 
  • Should be working on automation projects for last 2-3 years 
  • Expertise in Mobile Framework 
  • Experience in Linux Environment. 
  • Experience working in test automation frameworks 
  • Should have good understanding of test methodologies 
  • Should have very good communication 
Networking knowledge is advantage 
Apply Now
Electrical Engineer - EMC
 Electrical  Engineer - EMC
Electrical Engineer with 8+ years of relevant experience.
Analog & Digital Circuit Design experience; Board level testing & trouble shooting.
Schematic Entry & PWB Design Review; Exposure to Circuit Simulation.
Experience working EMI, Lightning Requirements & DO-160 based Qualification Testing.
Familiarity with Lab equipment's operation such as Oscilloscope, Multi-meters, Power supplies.
Experience with engineering documentation Test Procedures, Similarity reports, Test reports etc.
Ability to conduct meetings to present status, discuss technical details, and design reviews.
Apply Now
Medical device manufacturing line assembler position
Position: Medical device manufacturing line assembler position.
Duties & Responsibilities: • Assembly Operators are responsible for the assembly of medical components, subassemblies, products, or systems. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following EH&S policies and procedures. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). • Assembly Operators will need to document their work on travelers as the product move through the assembly process on the manufacturing floor • Assembly operators will be working along side other operators, technicians, as well as engineering staff in order to improve the existing MFG process, as well as to identify bottlenecks in the process Minimum Qualifications • 2-5 yrs experience in Medical device MFG environment • Experience with working in Cleanroom Environment • Comfortable working under microscope for long periods • Experience with handling of ESD sensitive devices • Ability to perform and demonstrate all MFG procedures after training • Accurately complete all essential documentation (LHR\'s, Inspection Records, Validation Documentation) • Great manual dexterity skills • Experience with conventional medical device MFG equipment (soldering irons, heat guns, hot box\'s, UV curing stations, tweezers, micro picks, etc). Preferred Qualifications • Experience working with flexible circuits, precision alignment processes • Knowledgeable with precision soldering, ACF Bonding, thermal bonding processes • Knowledgeable with PCB/PCBA rework • Experience with SMT (surface-mount technology) manual processes
Apply Now
Microsoft Azure Architect & D-365 Author
 Looking for a Microsoft Azure Architect and Microsoft D 365 Author immediately. I am looking at an experience of 5 year+ for both. Constraint. Individual can work remote, but may have to travel to Cincinnati, OH / Irvine, CA/Milpitas, CA. 
Apply Now
SQE Lead Auditor
 Job Title: SQE Lead Auditor
Location: Mahwah, NJ
Job type: Contract
Key Areas of Responsibility:
  • Knowledge of application of Regulatory requirement including ISO 13485, FDA and International requirements
  • Enhanced quality system requirements (QSR) throughout business unit by improving quality process and CAPA Closure
  • Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change management Process and as per ISO 13485 & CFR 21 Part 820 requirements
  • Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review & Approval
  • Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System (Track wise)
  • Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
  • Conducting Supplier's Pre-Assessment Audits with Sourcing & RAQA Leads.
  • Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and Onsite Audit through organization procedure
  • Collaborates with cross-functional and suppliers' teams to address top quality issues.
  • Own identified supplier driven non-conformances and manage the timely closure of NC's within Trackwise.
  • Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.
  • Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
  • Participates and may lead in the creation and/or review of new or modified procedures.
  • Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
  • Applies statistical methods of analysis and process control to external operations.
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
  • Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
  • Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.
  • Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
  • Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
  • Deliver continuous improvement activities focusing on supplier quality.
  • Participate in supplier audit program – planning, execution and closure.
  • Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
  • Ability to collaborate effectively with lead cross functional team

Basic Qualifications:\\
  • Bachelor's Degree
  • 5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
  • Fluent in written, oral in English and French
Preferred Qualifications:
  • Bachelor's Degree in Engineering or Science-related field
  • Understanding of US and International Medical Device Regulations.
  • Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
  • Strong interpersonal skills, written, oral communication and negotiations skills.
  • Strong in critical thinking and "outside the box" thinking.
  • Highly developed problem-solving skills. Strong analytical skills.
  • Demonstrated ability to work independently and as part of cross-functional teams.
Apply Now
Packaging Engineer
Job Title: Packaging Engineer
Location: Boulder, CO
Job type: Contract
EU MDR Packaging Engineer: 
Preferred: Bachelors Degree in Mechanical Engineering or Packaging Engineering with Medical Devices industry experience of 3 to 10 years;
Nice to have: Packaging Professional Certifications like CPP from IoPP, EU MDR knowledge and work experience;

Job Activities Include:
  • Sterile and Non-sterile Medical Device Packaging Design, Process Validation, Gap Assessment and Remediation as per EU MDR 2017/745, ISO 11607-1:2020 and ISO 11607-2:2020 requirements 
  • Transportation Ship Testing as per ISO 11607-1:2020 and ASTM D4169:2016 requirements
  • Packaging Stability Testing as per ISO 11607-1:2020 requirements
  • Packaging Sealer Process Validation (IQ OQ PQ) as per ISO 11607-2:2020 requirements
  • Technical Documentation: Protocol, Report and SOP authoring covering test plan, test methods, acceptance criteria, sampling plan etc., of the above-mentioned tests.
  • Packaging design of sterile barriers systems and non-sterile devices; Drawings and specifications creation of tray-lids, pouches, display boxes, shippers, retainers/ insert cards etc.,
  • Change Order Execution: Change Development Process (CDPs), Engineering Change Orders for drawings/ specifications, quality documents
  • Pallet Patternization
  • Working with cross-functional teams- Manufacturing Sites, Sterilization, Biocompatibility, Labeling, Quality, Regulatory, Testing Labs etc., globally, across business units for technical data mining, design review, implementation, and report preparation.
Apply Now
Mechanical Design Engineer
Job Title: Mechanical Design Engineer
Location: Boulder, CO
Job type: Contract

Job Description:
  • Experience in plastic part design and manufacturing
  • Create & initiate Engineering change Orders
  • Conduct Planning meetings
  • Initiate Engineering Change Orders (ECO\'s) and Reference Change Orders (RC\'s) for approval and closure of ECO deliverables.
  • Coordinate with relevant stakeholders for supporting documents required
  • Engineering & Validation documentation remediation DHF creation
  • Knowledge on FDA 820 CFR, ISO 13485
  • Knowledge on packaging is preferred
Apply Now