Job Postings

Job Title Equipment Validation Engineer

Job Description
Vastek, Inc. in San Diego, CA is seeking Equipment Validation Engineers to perform validation and develop validation documents for Laboratory instrumentation by following approved Standard Operating Procedures (SOPs, current Good Manufacturing Practices (GMPs), and all other regulatory requirements. Duties and responsibilities will include:

  • Responsible for developing and executing the validation plans according to the approved procedures, collation of test results, organize data packages and maintain all documentation pertaining to validation.
  • Comply and analyze validation data, prepare reports, and route documentation.
  • Manage Change Control Management System (CCMS).
  • Investigate and troubleshoot problems that occur during the development and deployment phase and determine the solutions.
  • Perform Periodic reviews and data integrity and security assessments as needed.
  • Coordinate and execute validation change control and preparation of draft protocols, reports, and data tables.
  • Participate in cross-functional project teams with the support of quality and other groups.
  • Contribute directly to the completion of projects through the management of assigned contract personnel, development, and execution of validation change control documents, and development and review of protocols, reports, and data tables generated by peers and contract personnel.
  • Independently apply validation principles to work assignments, review and approve documents and resolve problems.
  • Utilize standalone computerized instruments and software such as HPLC, UPLC, etc.

THIS POSITION DOES NOT SUPERVISE ANY OTHER PERSONNEL.

Minimum Requirements: Bachelor’s degree or higher in Business Administration, Information Systems, Management Information Systems, Computer Science, or any related IT field of study, plus at least one (1) year of experience in the job offered or in any related position(s) involving evaluation, validation and/or testing of systems.

No travel; no telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each long-term project.
Additional Information:

  • Job Site: 1230 Columbia Street, Suite 1180. San Diego, CA 92101.
  • Travel Details (if applicable): No travel; no telecommuting. Job duties are project-based and performed on long-term assignments at various unanticipated sites within the U.S. which may require relocation at the end of each long-term project.
  • Mail Resumes To: Bianca Garcia, HR. 1230 Columbia Street, Suite 1180. San Diego, CA 92101.
  • No calls or emails. EOE.

Must be legally authorized to work in the United States without sponsorship

Job TitleFT Financial Analyst, at Vastek Inc.
Company Vastek Inc.
LocationSan Diego, California.
Job typeFull-time.

Job Description
Vastek of San Diego seeks an FT Financial Analyst to conduct business process analysis and analyze business reqs for internal financial systems, conduct deficiency gap analysis using engineering principles, and design, develop and implement financial apps using VB and C++. MS in Engineering and 12 mos as Financial/Business Analyst req, inc exp with VB/C++/ASP.NET database mgmt tools & requirement traceability matrix & navigation of annuities IT. Fax resumes to 866-849-7714.

Job Title-FT Director of Market Intelligence, at Vastek Inc.
CompanyVastek Inc.
LocationSan Diego, California
Job TypeFull-Time

Job Description
Vastek of San Diego seeks an FT Director of Engineering to analyze the market demand for different contract engineering personnel & using analysis of metrics & knowledge of engineer principles determines suitability and feasibility of specific employees for specific client requirements Position will manage two professionals. MBA and BS in Engineering req plus demonstrated academic or professional experience with networks and distributed systems.
Please fax resumes to 866-849-7714.

Job Title FT Chief Operations Officer, at Vastek Inc.
Company Vastek Inc.
LocationSan Diego, California.
Job type Full-time.

Job Description
Vastek of San Diego seeks a FT Chief Operations Officer to design and implement business strategies, including laying out the strategy for marketing and management teams and evaluating success, set comprehensive goals for performance and growth, establish policies that promote company in the marketplace and ensure mission achievement, oversee daily operations of the company and the work of executives and managers and evaluate performance by analyzing and interpreting data and metrics. MBA and 24 mos as marketing executive req inc 12 mos exp in marketing and/or business development role as manager. Fax resumes to 866-849-7714.

Job TitleFT Financial Analyst, at Vastek Inc.
Company Vastek Inc.
LocationSan Diego, California
Job typeFull-time

Job Description
Vastek of San Diego seeks an FT Financial Analyst to conduct business process analysis & analyze business reqs for internal financial systems; conduct deficiency gap analysis using engineering principles; design, develop & implement financial apps using VB and C++. MS in Engineering and 12 mos as Financial/Business Analyst req, inc exp with VB/C++/ASP.NET database mgmt tools & requirement traceability matrix & navigation of annuities IT.

EOE. Apply to Fax # 866-849-7714.

Job Title-FT Manufacturing Engineering, at Vastek Inc.
CompanyVastek Inc.
LocationSan Diego, California
Job TypeFull-Time

Job Description
Vastek of San Diego seeks an FT Manufacturing Engineering Specialist to analyze the market demand for different contract manufacturing engineer personnel & use analysis of metrics & knowledge of manufacturing engineer principles, determine suitability & feasibility of specific employees for specific client requirements as well as the suitability of specific projects for fulfillment by company. Position requirements travel of 10+ weeks every quarter to field sites to analyze client needs. MS in Manufacturing/Industrial Engineer requirements.
Fax resumes to 866-849-7714.

Job Title-FT Director of Market Intelligence, at Vastek Inc.
CompanyVastek Inc.
LocationSan Diego, California
Job TypeFull-Time

Job Description
Vastek seeks an FT Director of Market Intelligence for its San Diego office to analyze the market demand for different IT techs, study about them & advertisement on resource allocation to attract labor & clients, & analyze & recommend content for targeted marketing materials relating to the marketing of tech professionals in different IT verticals.MS in IT/Computer Science and 24 months as Tech Marketing Profession including 12-months experience in the marketing of tech professionals requirements.
Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

Job Title Talent Management Specialist, at Vastek Inc.
Company Vastek Inc.
LocationSan Diego, California
Job typeFull-time

Job Description
Translating business directions into actionable hiring needs. Design and development of recruiting focus areas to deliver against business commitments. Analyze and evaluate the requirements of client companies to understand their needs for technology professionals to implement information technology projects. Handling the Vendor Management process, set the deadlines/ SLA’s to all the vendors/monitoring their performance. Advance the company brand across professional communities. Develop creative, cost-effective sourcing strategies to continually build a diverse pool of top-notch candidates. Establish and maintain efficient recruiting workflow processes and systems. Manage the maintenance and execution of the performance evaluation instruments. Define and utilize talent analytics to drive talent acquisition decision, recommendations and consultation. Design strategies in advertising company’s services with technology professionals. Maintain the overall delivery calendar to ensure an accurate view of resource availability, project availability, company priorities, and skill sets; Forecast gaps in staff availability and projects; identify at-risk engagements and coordinate with the sales team to make changes.

Must have proof of legal authority to work in the U.S. Must have a Master’s degree in Business Administration / related field with one year experience.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895Job Code- PY

Job Title Senior Manufacturing Engineer, at Vastek Inc.
Company Vastek Inc.
Location San Diego, California
Job typeFull-time

Job Description-

Reports to the Engineering Supervisor. Responsible for the implementation of project and process support activities toward attainment of departmental and plant goals. Primary focus in areas of capacity expansion, quality/waste improvement, and cost improvement programs. Required to handle multiple assignments of varying scope and complexity.

Essential Functions –

Responsible for the design and implementation of machine improvements and capital equipment project management activities. Proficient in mechanical design and troubleshooting. Directs personnel in the troubleshooting and maintenance of cam-driven mechanisms and pneumatic and hydraulic equipment used in the production process. Supports the plant manufacturing effort, with proven ability to identify problems and pursue plans toward their resolution. Specific focus will be in areas of improving upon chronic levels of quality, waste and equipment efficiencies. A clear understanding of the role of Engineering in a manufacturing environment.

Has knowledge of proper Engineering practices and vendor relationships. Responsible for coordinating activities between equipment vendors, Division R & D and plant functional departments on his/her assignments. Ability to handle projects of a moderate to large scope requiring extensive coordination. Will be required to handle several assignments (project & process duties) simultaneously. Prepares and submits capital appropriation requests and controls expenditures on these projects as required. Has knowledge of established safety standards and operator interface with the equipment. Completes or supervises the completion of necessary designs, drawings, calculations and specifications on associated equipment. Recommends vendors for commercial items and materials needed for a project. Establishes which elements comprising a job are suitable for in-house fabrication or revision and which items would be best contracted. Secure quotations and select contractors; direct the contractor’s efforts or the efforts of in-house forces to the satisfactory scheduled completion of the necessary work. Supervise and inspect all work-in-process by contractors or plant forces; provide guidance where necessary.

Responsible for the recommendation of capital equipment or process modifications, their physical installation, debugging and associated training of production personnel. Required to have awareness of product performance and quality requirements within the scope of his/her assignments. As required within the scope of his/her duty, be responsible for all associated documentation, including; however not limited to, the following; validations, Operations Procedures, Preventive Maintenance schedules, Engineering Change Notifications, spare parts listings, etc. Required to develop a firm understanding of all equipment for which he/she is responsible to include set-up, adjustment, and assessment of possible improvements. Responsible for realization of budgeted cost reductions and productivity improvements. Accountable for spending (capital or expense) within approved limits on programs.

Additional Responsibilities – 

Performs other duties as required by the Engineering Supervisor. Directs the efforts of support personnel such as machinists and technicians, etc. in the modification, adjustment, removal, and installation of new or existing equipment as required. May provide functional supervision of other Engineers toward attainment of his/her assignments.

Minimum Requirements-

Must have Bachelors Degree in Mechanical or Manufacturing Engineering. Must have a minimum of 5 years of work experience in a manufacturing environment. Must have high-speed automated assembly experience in the following areas synchronous and asynchronous assembly platforms cam-operated equipment pneumatics and servo controlled assembly. Understanding of Lean Manufacturing initiatives with an emphasis on continuous improvement. Six Sigma certification (greenbelt or black belt) preferred.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895

Job TitleQuality Engineer, at Vastek Inc.
Company Vastek Inc.
Location San Diego, California
Job type Full-time

Job Description-
Quality Engineer with at least a BS / MS in Industrial Engineering / Mechanical Engineering along with with an ASQ Certified Quality Engineering (CQE) and at least 4+ years of work experience in the Medical Device industry. Quality Engineer will be responsible for providing Quality Engineering support as a member of the cross-functional team responsible for manufacturing operations. This role supports the production of surgical sutures and polymer-based components for endoscopic and stapling surgical instruments.

Primary Skills-
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests, and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
– Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
– May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
– Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Validations and Measurement Systems Analysis (MSA).
– Work directly with component/raw material suppliers and Incoming Quality to include inspection plan creation and maintenance, PPAP (as applicable), and SCAR/NCR management.
– Process Validation and/or Root Cause Analysis experience
– Working knowledge of statistical methods and applications (Minitab experience a plus)
– Project management experience (familiarity with Microsoft Project – Gantt Charts).
– Familiarity with Lab operations/management.
Secondary Skills-
ASQ Certified Quality Engineering (CQE)
– Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
– Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints
– Support reliability activities for new product development. Drive for root cause understanding and corrective action implementation to ensure the product meets reliability requirements.
– Strong written and verbal communications (including presentation skills)
– Proficiency in Microsoft Project, Word, and Mini-tab

Educational Qualifications-
BS / MS in Industrial Engineering / Mechanical Engineering

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895 

Job Title Sr. Packaging Engineer, at Vastek Inc.
CompanyVastek Inc.
LocationSan Diego, California
Job typeFull-time

Job Description-

This position will support all product packaging design, development, verification testing and sustaining activities for the AIM and MDIS business groups.

Responsibilities –

  • Design and document new product packaging based on Marketing and interdepartmental core team requirements.
  • Work with local suppliers to develop package designs, with emphasis on manufacturability, recyclability, alignment to global hazardous materials regulations, ease of assembly/use and cost containment.
  • Authorship test plans, manage sample procurement and preparation, oversee test execution at a local test laboratory, and document test results in reports.
  • Resolve packaging related rejections in RI for existing packaging components.
  • Initiate ECRs/ECOs, provide packaging drawing redlines to drafting, and review incorporated drawings for completeness and accuracy.
  • Execute and document design reviews as necessary.
  • Present periodic project status reports to peers and senior leadership.

Educational Qualifications- Bachelor’s degree in Packaging Science, Engineering or equivalent.

Required Experience- Experience in commercial packaging design, medical device industry experience preferred. REQUIRED KNOWLEDGE: • Must demonstrate a broad and extensive knowledge of packaging engineering design principles and materials.

  • Understanding of ASTM test requirements and protocols
  • Experience using Agile PLM and SAP ERP software
  • Ability to write clear, concise test plans and reports
  • Knowledge of materials, finishing processes, and manufacturing methods required to meet the package design requirements.
  • Able to work with minimal supervision and can adapt to changing environments.

Desired/Preferred Qualifications (optional)

  • Experience in ETO and E-Beam sterilization packaging design
  • Experience in designing form/fill/seal pouches
  • Knowledge of RoHS Reach and other global environmental and consumer safety regulations.
  • Ability to use Solid-works and Auto CAD, CAD software, utilizing assembly configurations, part, assembly modeling techniques.           

 Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895 

Job Title Quality Engineer
CompanyVastek Inc.
LocationSan Diego, California
Job typeFull-time

Job Description-

The Beneficiary will be responsible for the position will be responsible for:
• Review and develop product Risk Management Report and Post marketing surveillance report by applying knowledge of ISO 14971 Risk Management; and collateral standards, IEC 62366 Usability, ISO 13485 and other applicable standards to ensure the peripheral vascular product is safe to use for the patient.
• Identify and manage risk throughout the product life cycle by reviewing the data from various sources like clinical evaluation report, field safety notice, complaint investigation and analysis, corrective and preventive action and FMEA (Failure modes and effects analysis).
• Provide clinical/medical input regarding classification of hazards and associated risk management activities.
• Drive and support internal process improvements that ensure client continues compliance to the requirements of the FDA and other regulatory bodies.
• Represent client as appropriate in FDA, notified body, internal, and other audits. Prepare Audit responses, agency communications, and milestones with respect to audit findings.
• Participate in corrective/preventive action teams to resolve systemic issues. Partner with cross-functional peers to resolve product performance issues (NCRs, CAPAs, deviations, process problems etc.) and to assess impact on device quality and product availability.
• Partner with multiple manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
• Assure products meet regulatory requirements including FDA Quality System Regulations 21CFR Part 820, Medical Device Directive (MDD) 93/42/EEC, Medical Devices Regulation ((EU) 2017/745, MDR), and internal client procedures.
• Support Regulatory Affairs by providing quality input for Clinical Evaluation Reports, Technical Documentation, and notified body submissions.
• Lead in the development, evaluation and execution of Test Method Validations (TMVs) which require the usage of statistical tools such as ANOVA.
• Participate in product development process to include design verification, design validation and process validation.

Educational Qualifications-At a minimum a Bachelor’s degree or equivalent in Biology or related.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895 

Job Title  Product development engineer
CompanyVastek Inc.
LocationSan Diego, California
Job typeFull-time

Job Description-This position will support all Product development engineer, development, verification testing and sustaining activities.

Responsibilities –

  • Work with Quality and R&D Engineers to review the product requirements, develop the process flow and coordinate with validation activities.
  • Perform Dimensional Inspection of tools/equipment used in the product development.
  • Writing Installation, Operational, Performance qualifications (IQ/OQ/PQ), TMV’s on process equipment as required, creating Engineering change orders and release designs for production with all necessary engineering documentation.
  • Execute design of experiments, Process characterization and time studies as apart of product development process and draft Engineering test reports.

Educational Qualifications- Mechanical engineering or equivalent.

Required Experience

  • Experienced in Product Requirement Spec (Design Specifications), Quality Plan/Traceability Matrices, Risk Management File (Design FMEA, Hazard Analysis), Design History File (DHF)  
  • Experience in Statistical Process Control (SPC) Methodologies and best practices Experience using Agile PLM and SAP ERP software
  • Ability to write clear, concise test plans and reports
  • Knowledge of materials, finishing processes, and manufacturing methods required to meet the package design requirements.
  • Able to work with minimal supervision and can adapt to changing environments.
  • Work with Quality and R&D Engineers to review the product requirements, develop the process flow and coordinate with validation activities.
  • Perform Dimensional Inspection of tools/equipment used in the product development.
  • Writing Installation, Operational, Performance qualifications (IQ/OQ/PQ), TMV’s on process equipment as required, creating Engineering change orders and release designs for production with all necessary engineering documentation.
  • Execute design of experiments, Process characterization and time studies as apart of product development process and draft Engineering test reports.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895 

Job Title Design engineer
CompanyVastek Inc.
LocationSan Diego, California
Job typeFull-time

Job Description- Responsible for the design, modeling, development and testing of a machine, structure or system. Develops functional requirements. Understands and applies standard engineering principles. Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates. Designs and tests components and integrates components to produce final product. Monitors quality of products and controls the efficiency of processes. Evaluates a design’s overall effectiveness, cost, reliability, and safety. Investigates root causes of failures to maintain quality and recommend improvements.

Responsibilities – • Develops system level design strategies and may lead design, development, testing & refinement of components and sub-systems.
• Development follows Invent It, Make It, Sell It procedures.
• Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations and presents possible solutions.
• Possesses and applies a broad knowledge of principles, practices, and procedures of a particular field of specialization to the completion of difficult assignments.
• Under general supervision, plans, conducts and supervises assignments.
• Reviews progress and evaluates results.
• Recommends changes in procedures and processes.
• Assignments are broad in nature, requiring originality and ingenuity.
• Has appreciable latitude for unreviewed action or decision.
• Guide and direct design engineers and senior design engineers in the same project.
• Fundamental understanding of IPC and IEC requirements as well as ISO organization related to electrical.
• Perform formal risk analysis and develop software mitigation. SW build, change control, and development/test process improvement.
• Development of research prototypes used to evaluate new product concepts.
• A desire to deliver a quality and innovative product that improves lives.
• Contribute to the definition and specification of future designs.
• Own/Support all phases of the product development lifecycle including design, implementation, debug, verification, validation, and transfer to manufacturing.

Educational Qualifications- Bachelor’s degree in Software Engineering, Electrical Engineering, or related field. M.S. in Software Engineering, Electrical Engineering preferred.

Required Experience• Requires a minimum of 5 years experience.
• Experience with designing software products in an FDA or other regulated industry.
• Familiar with concepts of design input, design output, trace-ability, and risk analysis.
• Able to debug software and hardware/schematics at higher level using logic analyzers, oscilloscopes, and simulators.
• Experience in concurrent cross-platform development preferred.
• Demonstrates mastery in system level software (drivers, RTOS, and test applications) in embedded environment.
• Expertise in debugging embedded systems without or with little emulator support.
• Understands product development processes including: Change Control & Design Control. Software Development Life Cycle . Fluent in: C/C++, Object Oriented Coding, Windows Embedded Agile Testing Tools: Code Warrior, Perforce or similar, Doxygen, Lab View, Matlab, Microsoft Visual Stud. Knowledge in embedded system design required. Understand integration of software and hardware required.
• Competent with Microsoft Office (Outlook, Excel, Word, etc.).
• Must possess excellent oral and written communications.

Email resume to info@vastekgroup.com or Apply to Fax # 858-810-0895 

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