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

Calibration Technician

Summary:

The calibration technician will inspect, test, maintain and repair a variety of electronic and mechanical equipment to ensure measurement accuracy. The calibration technician will also review customer requirements to ensure proper gaging is procured prior to manufacturing produces the parts.

Responsibilities:

  • Establish and maintain a calibration system to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results
  • Establish and maintain a calibration system to ensure that equipment is routinely calibrated, inspected, checked, and maintained. Ensure there are provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained
  • Ensure the calibration system is well documented to ensure equipment is calibrated on a routine schedule and are traceable to national standards when applicable
  • Coordinate calibration onsite service calls
  • Assists the quality department in developing and maintaining the ISO procedures and work instructions. Adherence to Cirtec operational procedures to maintain ISO and FDA compliance.
  • Ensure effective gage planning and procurement while being aware of cost impact and maintaining budget spending
  • Ensure that control of nonconforming product is identified, documented, evaluated, segregated, and disposition has been determined
  • Calibration of all measuring devices being conducted on time (0% past-due)
    • Maintain the calibration system and ensure no equipment is used beyond the recommended calibration period
    • Ensure all equipment is marked stating the status of calibration. If calibration is not required, the equipment will maintain a sticker stating reference only.
  • Create Gage kits for Manufacturing Teams within two days
    • Work with Engineering and Manufacturing teams to create Gage Kits for long running manufacturing jobs within two days of request.
  • Ensure gages are procured and received prior to start of production
    • Review released jobs and ensure gaging is ordered and received prior to start of production
  • Decrease the cost of Calibration
    • Continually look at ways to save money
    • Request quotes for procured equipment
    • Schedule multiple on-site calibration at same time to reduce cost
  • Developing time saving Inspection Methods
    • Enhance our capabilities, by leveraging automation, fixturing, etc., and be more efficient with inspections, but still maintain a high level of quality
  • Train and coach employees on all inspection, measuring, and test equipment and other courses as they are created
  • Communicate the quality status of all styles to the VP of Quality Affairs
  • Provide quality leadership and expertise to teams
  • Actively promote an environment that focuses on customer quality, continuous improvement and teamwork
  • Represents QA on project teams
  • Participate in internal, regulatory, and supplier quality audits
  • Participate in Material Review Board (MRB), as needed
  • Other tasks as assigned

Competencies:

  • Communication proficiency
  • Technical capacity
  • Ethical conduct
  • Problem solving/analysis
  • Decision making

Requirements:

  • 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
  • Solid troubleshooting, root-cause, and continuous improvement skills
  • Excellent written and verbal communication
  • Working knowledge of Microsoft Office
  • BS, high school diploma, or GED
  • Five years of related experience
APPLY NOW – email Careers@Cirtecmed.com

Maintenance

Summary:

Achieve and maintain a superior level of cleanliness throughout facility.

Responsibilities:

  • Maintain restrooms through the proper use of time and chemical
  • Offices: empty trash, vacuum floors, wipes down file cabinets and surfaces
  • Inspection Area: vacuum and dump trash, clean inspection tables
  • Production Area: vacuum all mats, dump trash, vacuum floor, scrub floor with auto-scrubber, maintain cleaning equipment, clean utility sinks, fill soap and towel containers, wipe down machine podiums and bar feeders, recycle bins
  • Police grounds for rubbish, maintain trash dumpster area
  • Safely use chemicals in the cleaning process
  • Maintain orderliness of janitor closets and maintenance office
  • Special projects and other duties of a similar nature and complexity, as assigned
  • Maintain cleanliness of all production equipment on production floor
  • Perform basic machine maintenance such as changing filters, replacing belts, and air and oil lines
  • Maintaining and keeping various machine log books current and up to date
  • Scrub floor with auto-scrubber in production aisle area daily
  • Maintain orderliness of manufacturing areas
  • Special projects and other duties of a similar nature and complexity, as assigned by Facilities Manager

Requirements:

  • Prior experience in floor care, carpet and tile.
  • Janitorial experience in a production or medical facility.

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 Careers@Cirtecmed.com

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

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

Operations Manager

Summary:

The Operations Manager is responsible for leading the manufacturing plant operations to achieve the required business results. This includes P&L responsibility for the schedule attainment, growth, profitability, safety, maintenance, quality, manufacturing engineering and material control for the business. Also, this position is responsible for managing the facility’s production associates, maintaining relationships, and managing culture as it applies to Cirtec Medical and facility safety for all employees. The operations manager will also partner with all groups to ensure the site is on track to plan by leading them through site objectives

Responsibilities:

  • Develop and deploy short and long-range plans to achieve the required business operational and financial objectives and drive associate engagement in the facility.
  • Develop appropriate performance metrics. Monitor and analyze production performance in the areas of safety, quality, cost objectives, delivery, major expenditures, and expense budgets. Take action as necessary to assure each objective is met.
  • Partner with key stakeholders to ensure that all required value streams and cross functional activities are being executed to achieve the required business results (i.e. driving cost reduction activities, maintaining fixed schedule, etc.).
  • Partner with all other areas, engineering, supply chain, and quality to ensure we hit the objectives for the site.
  • Partner with HR and Finance to ensure the workforce is adequate to meet the incoming order requirements for production labor. Promote engagement and harmonious working relationships between supervision, support functions and associates.
  • Implement process improvement to reduce inventory, drive out waste, improve manufacturing flexibility, improve quality, improve delivery, and reduce cost.
  • Optimize production flow, work instructions, rates, standards, and line support, etc. Manage machinery downtime and equipment maintenance and repair.
  • Insure duties and responsibilities of employees are clearly defined and communicated. Lead functional subordinates to deliver the business objectives. Mentor them in their personal and professional development as leaders of the business. Provide coaching/development opportunities that enhance their skill and support career aspirations.
  • Assist the GM of the sites in developing long-range plans, based on marketing forecasts and industry trends.
  • Lead with strong leadership to promote ideas with the team.
  • Lead the operations team with CIP ideas and use the talent within to create a culture of self-accountability.
  • Develop plans to create a self-staining work force.

Requirements:

  • 5+ year’s direct experience in manufacturing / metal fabrication / high volume assembly business.
  • Minimum 5 year’s management experience in satellite manufacturing or equal preferred.
  • 3+ years P&L responsibility preferred.
  • 2+ year’s strategic planning experience.
  • Operations strategic planning: 3 years
APPLY NOW – email careers@cirtecmed.com

Technician II

Summary:

A Manufacturing Technician II has the general responsibility for operating workstations and associated systems used in the manufacturing of products sold to our customers. The Technician II is expected to work with lower level Technicians and other upper level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Has the primary function of operating workstations used in the manufacturing processes
  • Proficient in set-up and loading component materials into product specific tools
  • Has the responsibility of following established documentation for product manufacturing
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines
  • Must accurately document all work performed on inspection reports and customer travelers
  • Must have a general understanding of the CNC controlled workstations on the production floor
  • Possesses the ability to read and follow process control documents, work instructions, and standard operating procedures
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions
  • Performs in-process visual inspections with and without the use of microscopes 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 associates assigned to assist them
  • Ability to perform basic workstation set up and troubleshooting tasks
  • Performs additional duties as required under the direction of the Production Manager
  • Maintains cleanliness of work areas, machines, tools and equipment
  • Assists Quality Control with inspection duties as required
  • Responsible for recognizing quality issues and communicating these issues to quality and/or Production Supervision
  • Performs other job duties as assigned with minimal supervision

Requirements:

  • Be able to read, write and speak fluent English
  • High school diploma or General Education Degree (GED) is required
  • One year experience in a technical field
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • In-house on the job training as required to meet job requirements
  • Work is performed in a low noise, well maintained manufacturing environment with the associated hazards of machine shop equipment, chemicals and electrical hazards
  • Protective laser eyewear is required while in environments where lasers are used
  • Decision Making & Problem Solving: Able to make clear and accurate decisions
  • Policies and Procedures: Able to conform to all established procedures and work activities
  • Able to communicate well verbally and in writing and work well in a team environment
  • Able to respond to changing priorities with minimum disruption
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

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