Careers with Cirtec – Medical Device Design, Development and Manufacturing

We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has rewarding opportunities where you can make a difference.

If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! We want to be your career choice in the Medical Device Industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.

To view all current positions and apply online, visit the Cirtec Career Center:

Opportunities in Brooklyn Park, MN

Business Systems Manager - Can be based in MN or CT

Summary:

This individual is responsible for supporting sales and marketing by driving the sales quoting process. This includes detailed technical analysis and proposal writing to support RFQ and grants applications.  This individual will work closely with Business Development, Operations and Finance to develop quotes, product pricing models and assist in the construction of overall program timelines.  In addition, he or she will analyze sales opportunities and support the approval process.  Finally, this individual will be responsible for developing dashboards and other strategic sales reporting tools.

Outcome Required & Strategic Priorities

  • Develop and implement quote process for new development and manufacturing opportunities
  • Develop quote metrics
  • Oversee all quoting activities, including existing manufacturing repricing to ensure financial objectives are being met

Main Responsibilities / Critical Tasks

  • Coordinate all quoting activities for Cirtec’s Brooklyn Park and Enfield operations.
  • Develop quote metrics and report to management periodically
  • Meet with perspective customers to understand needs and develop quote based on inputs
  • Assist with sales pipeline management

Skills & Knowledge

  • Technical Bachelor’s Degree, MBA preferred
  • Strong background in Class II and III medical devices (neuromodulation and cardiac assist knowledge a plus)
  • Strong industry involvement a plus
  • Program Management skills
  • Microsoft Project and general software skills required (Word, Excel, PowerPoint etc.)
  • Excellent communication skills both written and verbal
  • Strong financial background
  • CM Operational experience
  • Experience quoting design and development activities.
  • Experience building product cost models

Behavioral Competencies

  • Multitasker
  • Self motivated
  • Ability to plan and organize in ambiguous situations.
  • Exceptional communication and problem solving skills
  • Strong analytic skills
  • Critical thinker
APPLY NOW – email Joe.Stark@Cirtecmed.com

Master Scheduler

Summary:

The master scheduler/planner is responsible for managing the overall planning activities on an assigned workcell. Master planning responsibilities include, but are not limited to, ensuring a robust demand management process is in place to achieve 100% customer service level simultaneously driving to meet operational/financial goals & policies, which involves monitoring monthly revenue, forecasting, capacity analysis, and end-of-life (EOL) activities. Provides assistance in resolving data quality problems through the appropriate choice of error detection and correction, process control and improvement, or process design strategies collaborating with subject matter experts

Responsibilities:

  • Team champion and lead administrator of demand management process
    • Translate projected forecasts, incoming volume, and work scopes into a production plan with a time-phased build schedule
    • Provide input to finance on operating plans for the sales and operations planning (S&OP) process, concerning incoming volume and capacity
    • Develop customer commits to the demand plan based on material and capacity constraints
    • Maintain achievable build & ship plan, with focus on minimizing costs and internal lead-time
    • Monitor and maintain workcell capacity through use of capacity analysis tool
    • Drive data integrity in capacity analysis tool  (run rate accuracy, loading level and ramp rate agreement, and team education)
    • Effectively manage accurate cut-in dates resulting from Engineering Change Notifications (ECN’s), product transfers, and End of Life (EOL) activity
    • Mentor and lead production planner, ensure proper training and development on build readiness procedures
  • Support and actively participate in monthly revenue, forecast cycle
    • Track and communicate all revenue progression and risks to operations weekly
    • Maintain tool to understand financial impact of MPS to forecast revenue variance
    • Communicate all shift requirements, via capacity model, and all future changes in capacity
    • Manages, analyzes, and resolves data initiative issues and manages revisions needed to best meet internal and customer requirements while adhering to published data standards
  • Lead planning team in supporting company strategies, initiatives, and metrics
    • Define and track on-time delivery, Master Production Schedule, and material downtime performance
    • Utilize, develop, and refine standard planning processes
  • Develop firm understanding of cross-functional responsibilities, processes, and goals
    • Possess active knowledge of supply chain, inventory control, and manufacturing
    • Recognize critical components, pricing, lead-time, and high stocks
    • Action team lead in WIP tracking capabilities, BOM structuring, and process routings
  • Adhere to all company policies and procedures

Requirements:

  • BA in supply chain management or equivalent, along with 3-5 years’ experience in materials management related field
  • Strategic thinker, strong analytical skills, able to synthesize considerable and complex data and capable of utilizing spreadsheet and ERP-type software in managing the planning process
  • 3-5 years’ experience in scheduling position with extensive demonstrated success of implementing & operationalizing master schedules
  • Advanced PC skills, with emphasis on excel and ERP/MRP experience
  • Strong problem solving, negotiation, and people skills are a must
  • Ability to effectively and professionally work under pressure, in a team oriented environment
  • Business Data Owner – Authorizes the creation and maintenance of master data – Absolute responsibility for the quality and accuracy of local Master Data
  • Possess knowledge of production planning and MRP, clearly understand the process or loading and changing the MPS, along with the impact on MRP and the Material planners
  • Clear understanding of material liability agreement that is contractually in place
APPLY NOW – email Joe.Stark@Cirtecmed.com

Process Engineer

Summary:

Defines, develops, designs, and validateshttps://cirtecmed.com/wp-admin/post-new.php?post_type=landing manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department suggesting areas for improvements positively impacting product quality, cost and delivery.

Responsibilities:

  • Creates and improves processes pertaining to:
    • Feasibility Builds, Manufacturing, and Inspection
    • Equipment selection
    • Process development and documentation
    • Component validation and verification samples and testing
    • Develops and executes IQ, OQ and PQ protocols and reports
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process validation
    • Assembly and Component Process flow layouts
  • Involved with manufacturing and product design teams to:
    • Facilitate and create processes
    • Implement systems to produce a quality and cost effective product
    • Improve labor cycle times
  • Improve existing processes for boosting productivity, quality and cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user and customer
  • Prepares Engineering Change Orders for processes, components, and Bill of Materials
  • Performs and advises Corrective and Preventative Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 Plus years’ experience of medical device process or manufacturing engineering
  • 2 years’ experience with bonding techniques. I.E. – Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
APPLY NOW – email Joe.Stark@Cirtecmed.com

Process Engineer Technician

Summary:

Provides tools and support to engineering and production while adhering to the quality and cost requirements of the company. The tools included but are not limited to written processes and procedures, equipment and fixtures, and training programs. The development of these tools must be based on sound engineering principles and be implemented in accordance with Good Manufacturing processes (GMP) and ISO standards. This position will also support other engineers and areas as needed.

Responsibilities:

  • Identifies, executes and promotes Continuous Improvement objectives
  • Assists in defining Lean Manufacturing requirements
  • Develop processes and procedures for projects to improve quality and cost
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience
  • Represent engineering for Material Review Board concerning material dispositions
  • Represent Engineering in cross functional teams as assigned
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Maintains and prepares project plans to satisfy timeline requirements
  • Prepares Engineering Change Orders for processes and components
  • Performs Corrective and Preventative Action tasks
  • Other Duties as assigned

Requirements:

  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485)
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices
  • Experience with silicone molding is a plus
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software
  • Ability to interpret technical drawing, blueprints, specification and illustrations
  • Must be able to read, write and speak fluent English.
  • Excellent reading, writing, communication, and organizational skills.
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong desire to learn and apply new technology
  • Associates degree in an Engineering discipline or related field

This job description in no way states or implies that these are the only duties to be performed by the employee in this position. Employee will be required to follow other job-related instructions and to perform other job-related duties requested by any person authorized to give instructions or assignments.

APPLY NOW – email Joe.Stark@Cirtecmed.com

Laser Programmer

Summary:

This position is responsible for the safe and functional operation of laser cutting and welding equipment.  Will be responsible for developing manual or CAD programs required to cut or weld components.  Will assist in the development of tooling and fixtures required.

Responsibilities:

  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date

Requirements:

  • Recent pulsed laser cutting experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software
  • Formal laser education
APPLY NOW – email Joe.Stark@Cirtecmed.com

Quality Inspector

Summary:

The Quality Inspector ensures that all Cirtec products meet requirements for both visual and mechanical inspections as required based on print and inspection plans. Strict workmanship standards have been established and are taught to each employee.

Responsibilities:

  • Must demonstrate ability to perform visual inspections with microscopes at specified magnification and with a Visual Measuring System
  • Must be able to use Visual Measuring System and develop required statistical data
  • Ability to decipher blueprints and inspection plans to fully understand customer quality requirements
  • Attain knowledge of all Cirtec’s procedures, work instruction and forms related to your job process
  • Maintain a clean and orderly work area on a consistent basis
  • Communicate the quality status of all styles to the Inspection Lead
  • Read and follow Cirtec’s handbook and maintain an attendance and tardiness record within the set limits of company policy
  • Other tasks as assigned

Requirements:

  • Must have a minimum of two years final inspection experience
  • Self-starter, ability to handle multiple priorities, and detail oriented
  • A solid understanding of blueprint reading, geometric dimensioning and tolerances, statistical process control, visual inspection tools, and mechanical measuring tools
  • Excellent written and verbal communication
  • BS/BA/BE, AA, or applicable experience
APPLY NOW – email Joe.Stark@Cirtecmed.com

Swiss Machinist

Summary:

The primary purpose of this job is to set up, operate and maintain CNC equipment to fabricate production parts.

Responsibilities:

  • Operate and set up CNC shop equipment
  • Make adjustments and monitor assigned equipment to ensure dimensional part integrity
  • Able to preset tooling for setups and tool breakages during normal operations
  • Maintain tooling following established tool life guide lines
  • Troubleshoot and correct problem with minimal assistance
  • Inspect parts visually and dimensionally using basic inspection equipment and techniques to assure conformance to requirements with minimal assistance
  • Complete all applicable documentation for current operations
  • Perform preventative machine maintenance as required
  • Perform other functions as required

Requirements:

  • 2-5 years machine shop experience in all phases of machining
  • Ability to read, interpret and understand blueprints
  • Ability to work with small precision parts to very close tolerances
  • Ability to understand and follow through with verbal or written instructions
APPLY NOW – email Joe.Stark@Cirtecmed.com

In-Process Inspection/Deburring

Summary:

Deburrer needed to inspect parts for burrs, identify and remove burrs with speed and accuracy. To be a self-motivated individual with passion, integrity & commitment towards all work assignments. To produce the highest quality parts in the least amount of time.

Responsibilities:

  • Identify all burrs on part & proficiently remove them with minimal errors
  • Demonstrate the ability to read blueprints
  • Safely use knives and other deburring tools
  • Communicate effectively with team members
  • Maintain good attendance
  • Keep a clean and orderly work area
  • Accurately record data on routers
  • Ability to use general shop math
  • Proficient use of a microscope at 20 power minimum

Requirements:

  • One year experience working under microscope (at 20 power minimum)
  • 6 months experience using knives and other deburring tools
APPLY NOW – email Anna.Hable@Cirtecmed.com

 

Opportunities in Enfield, CT

HR Manager

Summary:

The main responsibility of the Human Resources Manager is to advise managers, supervisors and employees regarding the application of HR practices within the company.   The Human Resources Manager performs a wide variety of both complex and routine HR services supporting employee relations, recruiting (online or outside recruiters and negotiating contracts), training/career development, benefits, various type of Leave of Absence administration and has some compensation responsibilities. First point of contact to provide information to employees about regulations, company policies and general support.

Responsibilities:

  • Posting and advertising open positions and assisting in recruitment process at job fairs.
  • Developing and maintaining good relationship with universities, employment agencies and other recruitment resources.
  • Conducting analytic job studies and constructing valid selection and job related criteria. Screening, evaluating and recommending applicants for interviews.
  • Writing ads and posting open positions.
  • Participating in interviews as required and assisting staff members in identifying and creating job related interview questions.
  • Administering and explaining benefits to employees, serving as liaison between insurance carriers and employees. Manage Open Enrollment process.
  • Recommending, developing, and scheduling development and training courses.
  • Participating in development and execution of orientation programs and procedures for new employees.
  • Creating the necessary documentation for various Leave of Absence. Including FMLA, Disability, Pregnancy and other types of leave. Manage employee relationship, and facilitate communications with disability vendor.
  • Reviewing employee complaints and ensuring accurate and timely documentation of concerns or issues.
  • Create opportunities for employee recognition, employee engagement and community involvement.
  • Facilitating actions to resolve the employee issues and escalating them to appropriate management team.
  • Assisting in facilitation of on-site training program.
  • Maintaining employee files, recruiting files, medical files, I-9s, and any other paperwork to ensure compliance with all federal and state laws.
  • Managing annual performance review process.

Requirements:

  • Excellent presentation, communication and interpersonal skills.
  • Excellent problem solving skills are required to handle unexpected situations.
  • Ability to work with all levels of staff.
  • Ability to handle and maintain highly confidential information in an appropriate manner.
  • Knowledge of federal and state labor and employment laws
  • Intermediate skill level with Microsoft Excel and Word.
  • Strong level of understanding HR related legal issues and HR principles.
  • Able to work alone on a broad variety of projects. Must be self directed and able to work independently.
  • Able to exercise effective judgment, sensitivity, creativity to changing needs and situations.
  • Willingness to manage required administrative tasks, such as benefits enrollments, updating employee data, VOE’s, processing termination paperwork, etc.

Experience:

  • Minimum of 5 years’ experience in a multi-disciplinary human resource role with a strong familiarity recruiting, employee relations and benefits administration.
  • Degree, training or equivalent experience in computer use and software-Microsoft Word, Excel and PowerPoint.
  • Working knowledge of ADP WFN for payroll, HR data management, recruiting, benefits, and time and attendance tracking.
  • Experience working with Engineering and Manufacturing organizations required.

Education:

  • 4-year degree in related field or equivalent experience.
APPLY NOW – email careers@cirtecmed.com

Program Manager

Summary:

The Program Manager is responsible for executing the project plan and managing the project initiative to established budget and timeline. Coordinate the design, development, documentation, schedules, and validation of moderately complex new and modified customer products.

Responsibilities:

  • Organize a project plan for complex projects to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets internally and externally.
  • Serve as principal contact with clients.  Coordinate and direct site visits, conference calls, and day-to-day customer communication.
  • Coordinate development, validation and documentation of new products and expansion of existing products, including defining requirements, timelines, and deliverables. This may include engineering support of manufacturing operations for some products.
  • Proactively monitor the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommend and implement corrective actions.
  • Oversee the process of preparing new or modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Author planning documents as required to support assigned projects.
  • Contribute to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assist business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manage resources assigned to the project team to meet project goals/milestones.  Work with management to ensure project has proper resources assigned.
  • Other duties as assigned.

Requirements:

  • Bachelor’s Degree, preferably in an Engineering Capacity.  Masters preferred.
  • 3+ years in a Program Manager role, directly managing a project, budget and resources for mulitple clients
  • Medical Device industry experience strongly preferred, or another regulated manufacturing industry
  • Exceptional organizational and communication skills. Ability to manage progress on multiple complex projects
  • Business acumen to understand business financials
APPLY NOW – email careers@cirtecmed.com

Production Supervisor -2nd Shift

Summary:

Direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives.Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met
  • Responsible for ensuring conformance to all company policies, procedures and work instructions
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance
  • Conduct daily team meetings for proper communication and development of production team
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs.  Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC)
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary
  • Understand the requirements of and ensure compliance with the preventative maintenance program
  • Other duties as assigned

Requirements:

Education

  • Be able to read, write and speak fluent English
  • Associates degree or equivalent experience in a related field

Technical

  • Computer literate (MS Office Suite, Syteline)
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving
  • Strong knowledge of ERP/MRP business functions
  • Able to prioritize and manage multiple responsibilities
  • Must be able to read blue prints and interpret technical specifications and illustrations
  • Experience in technical report writing and verbal communication skills
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role
APPLY NOW – email careers@cirtecmed.com

Laser Technician Levels I-IV

Summary:

The Laser Technician has the general responsibility for operating laser and associated systems used in the manufacturing of products sold to our customers. The Technician is expected to work with and assist in the training of lower level technicians to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position the Technician will continue to build their skills with the upper level Technicians along with taking tasks and direction from the Engineering departments. In this position you must proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Has the primary skills of operating manufacturing workstations including all laser systems used in the manufacture of products sold to our customers. (Unitech, Triumpf, Lasag, IPG)
  • Perform laser welding, resistance welding laser marking, header pouring, silicone molding
  • Glovebox laser welding
  • Strong soldering experience. IPC 610 certification preferred
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines
  • Proficient in the operation of computerized motion controllers
  • Proficient, at an intermediate level, in modifying or creating computerized motion control programs
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions
  • Working knowledge of drawings with an intermediate ability to interpret nomenclature and dimensions
  • Must accurately document all work performed on inspection reports and travelers
  • Performs in-process inspection of all parts and/or assemblies in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
  • Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers
  • Provides direction within the manufacturing cell to Tech I or II associates assigned to assist them
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities
  • Assist facilities departments and upper level Technicians in duties such as flash lamp or filter changes on lasers
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters
  • Performs additional duties as required under the direction of the Production Team Leader or upper level Technicians
  • Responsible for recognizing quality issues and communicating issues to the Quality and/or Production Supervision
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations
  • Assist Upper level Technicians or Engineers with parameter adjustments and weld parameter/process development
  • Ability to perform metallurgy (cross sections)
  • Performs weld validations and collects data for validation reports
  • Ability to provide input to Engineering and upper level Technicians in regards to tool design and/or troubleshooting processes
  • Performs other job duties as assigned with little or no assistance or supervision

Requirements:

Experience & Education

  • Be able to read, write and speak fluent English
  • High school diploma or General Education Degree (GED) is required
  • Two to three years’ experience in a med device field preferred
  • One year applications experience or equivalent training

Technical

  • Strong experience with a variety of laser welding equipment and techniques
  • Strong soldering skills (IPC 610 certification preferred)
  • Header pouring, laser marking, silicone molding, glove box laser welding
  • Moderate computer skills, including the MS Office suite
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources
  • Ability to learn and apply new technology
  • Technical report preparation

Physical

Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

APPLY NOW – email careers@cirtecmed.com

Quality Engineer

Summary:

Provide oversight, guidance and management of business critical Quality Systems, including internal/external complaints, supplier management, internal audits, and quality metrics.

Responsibilities:

  • Manage all aspects of CAPA system for internal and external complaints.  Includes tracking of issues, follow up with responsible personnel, root cause analysis, and reporting of status
  • NCR (Non-conforming material report) ownership to track progress, monitor trends, ensure timely closure, and reporting of status.
  • Supplier quality management to ensure all Cirtec suppliers are meeting quality standards. Maintain data to maintain and assess vendor performance
  • Partner with Purchasing to perform Supplier Quality Audits based on schedule and in response to existing issues
  • SCAR management for supplier quality corrective actions – root cause analysis, follow up, closure
  • Ownership of internal audit system, including performing tasks of Lead Auditor.  Determine appropriate auditors, coordinate training, conduct monthly meetings, create audit schedule, and ensure audits are completed on time. Report results as requested.
  • QMS
  • Maintain all Quality metrics for monthly reporting, and for Management Review
  • Complaint management for both internal and external complaints related to Quality
  • Continuous improvement of existing quality systems
  • Interact effectively with internal and external contacts to drive results

Requirements:

Education:

  • Bachelors of Science or equivalent, preferably in an engineering discipline
  • Minimum 2 years’ experience in medical device manufacturing environment
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office
  • Must possess excellent verbal communication, organizational and management skills

Technical:

  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement
APPLY NOW – email careers@cirtecmed.com

Quality Inspector

Summary:

Perform receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results.  Indicate inspection status, maintain product traceability and non-conforming material control.  Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel
  • Indicate inspection status of parts with assigned labels and stamps
  • Maintain product identification and traceability
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action
  • Protect product during handling and storage in the performance of work
  • Monitor factory environmental conditions, record data and alert adverse conditions
  • Assist with distribution and control of process documentation and quality records
  • Assist with control of measuring and test equipment calibration
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action
  • Provide input when required to quality planning for specific projects and products
  • Provide support to production personnel on quality issues
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards
  • Follow Occupational Safety and Health regulations, including laser safety practices

Requirements

  • Be able to read, write and speak fluent English
  • High school diploma or GED
  • A minimum of 1 year experience as a Quality Control Inspector preferred. Must have familiarity with inspection procedures in a manufacturing environment
  • Medical device experience strongly preferred
  • Experience in documentation of technical data
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications
  • Strong analytical and technical aptitude, with exceptional attention to detail
APPLY NOW – email careers@cirtecmed.com

Strategic Sourcing Specialist

Summary:

The Strategic Sourcing Specialist is responsible for the development and execution of sourcing strategies. Responsible for achieving best total value by leading the negotiations and supplier management with the company supply base, driving the strategic sourcing process across multiple sites, leading and supporting the development, implementation and management of supply chain strategies and providing optimal supply assurance, including pricing, flexibility, quality and delivery performance.

Responsibilities:

  • Builds and leverages strong working relationships with internal customers and key suppliers to assure cost, quality, and delivery targets are met. As the primary supplier relationship owner, responsible for negotiating prices, terms and conditions, risk mitigations and warranties in support of those agreements
  • Communicate and implement strategies, contracts, and pricing with an overall focus on maintaining good supplier relationships and minimum total cost of ownership to achieve maximum advantage for the company and its customers
  • Develop key performance measures for chosen suppliers and negotiate on multiple variables to award longer-term strategic contracts that result in significant cost reductions and improved service levels
  • Analyze current spend and evaluate current suppliers. Consolidate spend to create leverage, analyze purchasing trends and develop sourcing alternatives
  • Support new product introduction (NPI) programs by coordinating all sourcing and supplier qualification activities across sites
  • Researches, identifies, and analyzes current and emerging procurement trends, develops a deep understanding of market conditions, proposes global supply chain solutions focusing on total cost of ownership
  • Works closely with Finance to ensure proper segregation of duties with respect to Supply Chain. Creates policies and programs as needed to ensure compliance with Cirtec directives
  • Familiar with customs regulations for import of products from foreign countries

Requirements:

  • BA/BS +5-7 years of work experience- relevant work experience with in the medical device industry strongly preferred
  • Extensive knowledge of supply chain planning, sourcing, inventory management, purchasing, logistics & experience in working with engineering and quality teams to collaborate on supplier development
  • Experience supporting new programs with quick turnaround time on quotes for accurate pricing on new business.
  • Strong negotiation skills
  • Experience working with a medical device contract manufacturer desired
APPLY NOW – email careers@cirtecmed.com

Opportunities in Los Gatos, CA

Principal Systems & Electrical Engineer

Summary:

The Principal Systems & Electrical Engineer will provide Systems Engineering expertise and functional supervision to the Electrical Engineering Department. This person will direct, lead and manage the technical activities of system design, requirements management, electronic design, hardware reliability and system integration for multi-disciplinary medical device technologies. This person will become actively involved in the design and development of products as required to meet schedules and resolve problems.

Responsibilities:

Develop electronic and electromechanical specifications, test plans and verification reports.

Develop, model, analyze and design electronic and electromechanical subassemblies.

Perform and document system performance and budget analyses (tolerance stackups, error budgets, power, weight and cost breakdowns, etc.)

Provide support and supervision to direct reports and contractors for the timely completion of projects, initiatives and key activities.

Mentor associates and foster a learning and growth environment.

Serve as a principal contact with clients; arrange meetings to discuss upcoming projects, instilling confidence in our technical capabilities and quality products.

Organize a project plan to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.

Maintain project and product cost.

Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.

Oversee the process of preparing new or modified products ensuring compliance to internal and customer requirements.

Provide leadership of multi-disciplined teams that will execute projects from the development phase through production.

Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.

Interface with quality engineering to help maintain accurate policies and procedures and respond to audit findings.

Identify Electrical Engineering resource needs for programs and assist in recruiting appropriate talent.

Other duties as assigned.

Requirements:

BS/MS in Electrical Engineering or a related engineering discipline.

Experienced with Systems Engineering and Requirements Management.

Familiarity with and ability to manage projects involving embedded microcontrollers, hardware architecture, embedded software design, motor and control feedback circuits, sensors, mixed signal circuit design and PCB layout.

Ability to work with a wide variety of people, including Manufacturing, and QA, as required accomplishing results with little overall guidance.

Strong verbal and written communications skills to effectively prepare specifications, protocols and reports and formal presentation skills.

Minimum of 5 years of product development leadership with a demonstrated ability to lead projects successfully from early stage development to production.

Minimum of 10 years in systems and/or electrical engineering design and development, preferably for Class II or Class III medical devices.

Strong computer skills, including the MS Office suite and MS Project.

Must be able to fully interpret technical drawings, specifications and illustrations.

Will attend technical classes and seminars as required to enhance job performance.

APPLY NOW – email careers@cirtecmed.com

Process Development Engineer

Summary:

The Process Development Engineer will be responsible for the development and manufacturing of mechanical designs for the creation of external and implantable medical devices.

Responsibilities:

Applies engineering knowledge and skills as technical engineer for all phases of development projects.

Participates in the creation of specifications and develops designs to meet those specifications.

Participates hands-on in developing prototypes.

Generates and executes test protocols to verify functionality.

Creates and releases medical device manufacturing process instructions, bill of materials, lot history travelers, and related documentation.

Sometimes coordinates and schedules other staff to work on specific tasks.

Communicates directly with clients to understand needs and present results.

Effectively interfaces with and manages suppliers to fabricate prototype and final design components.

Participates in product risk management and develops and implements risk mitigation strategies.

Requirements:

Minimum BSE/BSME with 2-5 years of experience within the Medical Device industry.

Knowledge of materials and processes used in manufacture of catheters and other medical devices preferred.

Experience in creating product specifications, test protocols, manufacturing procedures.

Experience with SolidWorks.

Excellent communication skills both written and oral.

Familiarity with medical device design control processes.

Familiarity with medical device packaging systems and related testing.

APPLY NOW – email careers@cirtecmed.com