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

Sr. Manufacturing Engineer

Summary:

Defines, develops, designs, optimizes, and validates manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department executing improvements that directly impact product quality, cost and delivery.

Responsibilities:

  • Creates and improves manufacturing methods 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
  • Provide input for preparing customer proposals and quotes
  • Participates with process and design 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, routers and bill of materials
  • Performs and advises Corrective and Preventative Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP, GDP principles and practices
  • Must have 5 plus years’ experience of medical device process or manufacturing engineering, contract manufacturing is a plus
  • Exposure with bonding techniques. I.E. – Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Experience with Pro-E / CREO and or SolidWorks with GD&T exposure required
  • 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
  • Strong desire to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline
APPLY NOW – email Careers@Cirtecmed.com

Materials Specialist - 2nd Shift

Summary:

The Materials Specialist is responsible for the kitting and issuing of Clean Room assembly jobs and inventory control of materials.

Responsibilities:

  • Return materials from completed clean room jobs back into inventory and also in M2M
  • Daily review of “Released” jobs each day from ERP system for kitting and issuing materials to assigned jobs
  • Kit and issue materials and components to jobs
  • Communicate to appropriate departments each day regarding what jobs have been kitted with components that may cause shortage issues
  • Maintain inventory control by performing cycle counting on a monthly basis and provide reports by the 10th of each month
  • Work with Shipping Coordinator on inventory control by cycle counting of precious, non-precious and assembly components on a monthly basis and provide report by the 10th of each month
  • Work with Shipping Coordinator on packaging and shipping products to customers
  • Assist with shipping at the end of the month to ensure all shipments are off Cirtec Medical premises at month end
  • Other duties as assigned

Requirements:

  • Basic math skills
  • Proficient typing skills
  • Detail-orientated
  • Basic Inventory Control
  • Customer service aptitude
  • Personal computer skills (Microsoft Office Products)
  • M2M or Equivalent ERP/MRP system experience
  • Good communication skills
APPLY NOW – email Careers@Cirtecmed.com

CNC Milling Machinist

Summary:

To set up and maintain all set-ups on CNC machinery. To be self-motivated and ensure the product is done on time and of the highest quality possible. To have excellent trouble shooting ability on both the machine and tooling and to assist the supervisor and/or lead person as well as the programmers with the operation of the department.

Responsibilities:

  • Accurately complete all department paperwork including job travelers, inspection documentation, and work packet information and tooling request forms
  • Have a general understanding of Cirtec Medical workmanship standards
  • Be able to maintain an acceptable efficiency operating machinery
  • Have the ability to change most types of tooling used in various machines
  • Active participation in team meetings and improving quality programs
  • Be familiar with functions of the machine including tool and work offsets and be able to adjust them to ensure quality components are being manufactured
  • Demonstrate concern for equipment by proper use of all equipment and maintaining a clean work environment
  • Demonstrate an ability to use inspection equipment as required, including vision systems
  • Have the ability to solve problems to maintain quality and efficiency while working within the team
  • Have a good attendance record
  • Have the ability to pass internal blue print reading and workmanship tests
  • Understand company policies and procedures
  • Maintain a high level of quality
  • Excellent working knowledge of blueprints and geometric tolerance
  • Interact effectively with engineering and quality individuals to solve problems that may arise in a professional and timely manner
  • Have extensive knowledge of all phases of machining and equipment
  • Demonstrate good decision making and problem solving
  • Continually train co-workers to encourage individual growth within the team and within the company
  • Have the ability to set up and run all jobs within the department
  • Promote good morale and productivity
  • Have the ability to increase production and streamline set-ups for optimum efficiencies and quality
  • Have the ability to trouble shoot quality problems by effectively utilizing process control and corrective actions
  • Maintain a very high level of cleanliness and organization and promote this within the team

Requirements:

  • Ability to interpret tolerances, GD&T, dimensions, finish requirements, part views, etc. on engineering blue prints
  • Minimum of 3 years of experience with set-ups, operating and troubleshooting CNC vertical mills
  • Ability to operate vision systems and inspection equipment
APPLY NOW – email Careers@Cirtecmed.com

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 - 3rd Shift

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 Careers@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 Careers@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 Careers@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 Careers@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 Careers@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

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

Opportunities in Los Gatos, CA

There are no opportunities available at this time.