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

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.

Opportunities in Brooklyn Park, MN

Programmer - Swiss

Summary:

Provide Programming and develop a number of highly skilled machinists with superior setup skills. To ensure the product is done in the most efficient manner and of the highest quality possible. To follow the department budget and is responsible for the company and department goals. To be self-motivated.

Responsibilities:

  • Maintains CNC programs for Cirtec Medical through the use of Cam software or other valid programming methods
  • Develops a complete knowledge of management software as it pertains to the shop
  • Continually trains co-workers and demands individual growth within company
  • Trains employees on all aspects of CNC programming and documents training upon completion
  • Controls program changes to locked programs
  • Must be adaptable to a changing work environment, competing demands and is able to deal with frequent change, delays or unexpected events
  • Studies and interprets drawings, manuals, specifications or sample parts to determine dimensions and tolerances of finished work pieces, sequence of operations and setup requirements
  • Observes machine operation to verify accuracy of machine settings and to detect malfunctions or out-of-tolerance machining, using precision measuring instruments
  • Effectively resolves all problems that arise or seeks assistance in a timely manner
  • Performs duties in a manner to promote good department morale with the team concept
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Promotes efficiency and quality within the company
  • Participates in maintaining budget goals
  • Initiates and drives lean manufacturing events to achieve company goals

Requirements:

  • Possess an advanced level of programming skills with ESPIRIT, or Gibbs software or equivalent programming software. This includes the ability to apply advanced programming to complicated medical components.
  • Minimum of 10 years’ of experience in programming that required interaction with internal and external customers
  • Strong math and trigonometry skills
  • Ability to interpret blueprint reading and engineering specifications
  • Must have exceptional communication skills and work well with people
  • Must possess a keen sense of attention to detail
  • Must have a very good working knowledge of lean manufacturing
APPLY NOW  – or email Careers@Cirtecmed.com

Laser Technician | 2nd Shift

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. To be self-motivated. Help lead the team in a manner to maximize production, Quality, and day-to-day functions.

Responsibilities:

  • Provides process training to production operators
  • Performs characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provides Laser samples when appropriate to support sales effort
  • Provides assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develops CNC programming using a camming software to efficiently meet print requirements
  • Assists Engineering in designing tooling for production
  • Interfaces with Quality to develop inspection procedures to verify acceptability of components
  • Maintains and promotes laser and team safety
  • Evaluates and recommends alternative manufacturing methods
  • Maintains and encourages others to maintain a clean and orderly work area
  • Researches and recommends capital equipment for the yearly budget
  • Ensures laser maintenance program is 100% up to date
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seeks assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner

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
APPLY NOW  – or email Careers@Cirtecmed.com

Laser Operator | 2nd Shift or Weekend Shift

Summary:

Effectively operate a laser cutting or welding machine and monitor quality work at an acceptable rate. Keep the area that they are working in and follow the cleanroom cleaning procedure. Able to read and comprehend blue prints for client requests. Communicate with departing shift to learn the status of jobs in progress

2nd Shift: Monday – Friday, 3:30 PM – 12:00 AM

Weekend Shift: Friday – Sunday, 6:00 AM – 6:30 PM

Requirements:

Previous laser machine experience (1-2 years)

  • Experience with high tolerance cutting, welding and drilling of metals
  • Blue print reading
  • Availability to work overtime (shift and weekends)
  • Previous experience working in a cleanroom environment
APPLY NOW  – or email Careers@Cirtecmed.com

Tool Designer - Stamping

Summary:

Supports product development and sales activities. Works collaboratively to improve the efficiencies at Cirtec Medical, which include design methods, prototype processes, tool build and debug methodologies, tool reliability, and maintenance practices with a primary focus on the new build process.

Responsibilities:

  • Works collaboratively with the sales teams as well as potential and existing clients to respond to technical inquiries when requested
  • Creates strip lay outs or concept drawings as needed to aid in the feasibility of projects to be used internally or externally with customers; these drawings may be of piece parts, tooling, jigs, fixtures, machines etc.
  • Leads in research and development activities to assist in product or tooling development
  • Provides input to the estimators on key projects regarding the type of tooling that should be quoted for prototyping, short term, and final production, tooling material costs, and labor hours to obtain a competitive quote, doing so within the time allowed to meet internal quoting goals
  • Ensures that assigned prototype and tooling projects are being constructed as per plan in the most efficient methods. Provides support and or work direction in the building of assigned tooling, jigs, fixtures, and automated equipment to ensure that projects are completed on time, capable of producing parts to customer specifications, and targeted costs
  • Complies with die standards and provides input on keeping these documents updated with latest practices
  • Aids in or creates methods or work directions that will be used during the running of proto-type tooling internally
  • Assists in the debug process or startup of new tooling. Provides input on changes as needed.
  • As assigned, leads efforts to address issues with production tooling that doesn’t meet the established production goals
  • Continues to suggest improvement goals for all tooling-related departments
  • Participates in mini-Improvement meetings and training activities as required
  • Provides input on standardization or the initiation of new tooling concepts or methods to our current systems to reduce the costs of tool manufacturing, debug and tool maintenance
  • Serves as a resource to toolmakers, the wire EDM room, and stamping department, providing information, help and solutions to both existing problems as well as pro-actively preventing potential problems
  • Verifies that any changes being made to tooling do indeed remedy the issues being addressed and are documented
  • Makes recommendations on capital equipment purchases
  • Assists in the planning of the installation of new equipment within the organization
  • Keeps management informed of progress in assigned areas and reports any unique problems with recommendations as to their solutions
  • Effectively communicates with other departments, supervisors and managers, including participation in and/or facilitation of meetings
  • Designs, produces drawings and specifications for cost effective complex tools, dies, gauges, jigs and fixtures to be produced by the toolmakers
  • Working from process sheets and prints of parts, designs tooling that meets customer’s needs and specifications and is consistent with machine limitations, the quantities to be produced and tolerances specified
  • Works with current software, including CAD system and MRP to produce designs and drawings
  • Supports the activities required to implement and maintain the company’s strategic goals, educational goals, departmental objectives, and continuous improvement activities
  • Actively participates in industry associations and studies the latest technology in area of expertise making recommendations for adaptation within as appropriate. Provides recommendations for potential applications
  • Pro-actively pursues continuing education and personal development opportunities in area of expertise
  • Determines if any changes being made to the tooling or processes will require customer approvals and follows the required procedures to do so
  • Follows all Company and ISO procedures. Actively participates in continuous improvement initiatives

Requirements:

  • Completion of necessary training for Tool and Die Maker or Tooling Designer
  • Strong analytical, technical and communication skills; excellent customer relations skills
  • Five years tool and die related manufacturing experience – experience with progressive dies and a variety of different tools and automated machines preferred
  • Experience in trouble shooting progressive tooling effectively
  • Proficient in Auto CAD and SolidWorks CAD software
  • Demonstrable knowledge in the use of CAD/CAM systems and other design software
APPLY NOW  – or email Careers@Cirtecmed.com

Machine Operator 1 | Weekend Night Shift

Summary:

To monitor all of the lights out Milling machines as well as secondary operations machining.

Weekend Night Shift: Friday – Sunday, 6:00 PM – 6:30 AM

Responsibilities:

  • Monitor and load fixtures for Milling machines
  • Visual and in-process inspections
  • Secondary machining operations
  • Other machine-related duties

Requirements:

  • Must demonstrates concern for equipment by proper use of all equipment and maintaining a clean work area
  • Must demonstrate an ability to use inspection equipment as required
  • Must have the ability to solve problems of quality and efficiency working within the team and independently
  • Entry-level machining skills required
APPLY NOW  – or email Careers@Cirtecmed.com

Program Manager

Summary:

Brings product from concept through defining, developing and designing Medical Devices, owns efforts in developing solutions to product design. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs.  Effectively communicate to all levels of management and production personnel. Prioritize tasks based on direction given by management to ensure all project deliverables are completed successfully.

Responsibilities:

  • Owns the design and development of product through:
    • Performing timely research
    • Transforming customer product expectations into results
    • Developing full design requirements, product design, specification creation with mechanical and electrical components and assemblies
    • Involved in all aspects of the product development life cycle, feasibility, electronic architecture, schematics, bread boarding and testing
    • Creating test methods, design verification and validation activities
    • Product development, qualification and validation
    • Design and build prototype fixtures and tooling, defines equipment needs
    • Sourcing materials for prototype builds
    • Assist transferring to manufacturing
    • Operator training
    • Clinical builds
  • Plans, schedules, conducts, and coordinates detailed phases of engineering work in projects of technical/design scope. Makes suggestions for and may implement design improvements to meet user requirements
  • Performs problem solving, task planning, design review activities, requirements generation, customer communication, and any other skills as designated
  • Provides regular status updates to management and or customer
  • Performs design reviews and pre-validation assessments to ensure a safe and environmentally sound start-up of new design/technical recommendations
  • Works with sales to review and evaluate new opportunities and provide technical assessment of risk
  • Writes/updates work instructions, part specifications, validation protocols, and various technical documents, Design History Files, Device Master Records, DFMEA and PFMEA
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Owning and/or participating in DFMEA, PFMEA, and Risk analysis activities
  • Development of user requirements and product requirements documentation
  • 5+ years’ experience in the medical device industry with responsibility for materials, designs, and processes on electro-mechanical implants or external devices, strong experience with Implantable Pulse Generators (IPG’s) is required
  • Class II and III electrical design and testing experience under ISO Standard 13485, along with experience testing to IEC 60601
  • Materials biocompatibility
  • Broad electrical experience in micro processing design, wireless technologies, circuit power management, sensors, data gathering and data processing
  • Firmware experience is a plus
  • Creating and developing of specifications and relevant test methods
  • Design verification and validation
  • Design for Manufacturing (DFM)
  • Possess a strong desire to always learn or design new technologies
  • SolidWorks
  • Thorough understanding of mechanical and electrical assemblies
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Experience/expertise in experimental techniques
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • A BS degree in relevant engineering discipline with a minimum 5 years of related engineering experience, or its equivalent design related experience
  • Possess a basic understanding of engineering theoretical fundamentals including a basic knowledge of materials science, electrical and mechanical engineering principles
APPLY NOW  – or email Careers@Cirtecmed.com

Process Engineer

Summary:

Defines, develops, designs, and validates 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
    • Planning and executing process characterization activities, through tools i.e. design experiments
    • 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 Preventive Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more 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  – or email Careers@Cirtecmed.com

R&D Process Engineer

Summary:

Defines, develops, designs, and validates 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
    • Planning and executing process characterization activities, through tools i.e. design experiments
    • 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
  • Improves existing processes for boosting productivity, quality and cost
  • Assists 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 Preventive Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more 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  – or email Careers@Cirtecmed.com

Sr. Engineering Manager

Summary:

This position is primarily responsible for the management and execution of development projects, with a focus on ensuring customer needs are met in regards to quality and delivery. Responsible for assisting Engineering, Technicians, Program Managers and Quality by providing processes, technical and operational guidance and by administering standard processes and programs to ensure effective, timely and accurate project execution and customer satisfaction. The Engineering Manager leads the Engineering Department and works closely with Operations.

Responsibilities:

  • Develops and implements a short and long-term advancement plan to meet established development goals and objectives
  • Provides daily management of advancement staff including establishing annual goals
  • Manages to the budgets of development projects
  • Establishes goals and responsibilities for engineers, PM’s and technicians working on neurostimulation, machining, other non-cleanroom, and cleanroom-based projects (development and sustaining)
  • Develops standard methods to manufacture prototype, pre-production, and ready to transfer to production levels of cleanroom products
  • Develops detailed development schedules for all development projects
  • Works with supply chain on materials need for all programs
  • Creates budgets for the development team
  • Helps define manufacturing floor configurations to provide efficient process flows
  • Identifies cost reduction opportunities in manufacturing process or product design and facilitates execution of cost reduction projects
  • Maintains communications with customers regarding manufacturing project and process status
  • Provides feedback during the weekly SOP process
  • Interacts with customers to provide update of status; helps convey and address issues found with design or manufacturing processes
  • Provides input for budgets and capital equipment acquisition

Requirements:

  • 4-year degree plus 10 years complex assembly manufacturing engineering work experience in a regulated environment
  • Process development experience
  • Project management experience
  • 10 years of leadership experience
APPLY NOW  – or email Careers@Cirtecmed.com

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
  • Improves existing processes for boosting productivity, quality and cost
  • Provides 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 3 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
  • Exposure to injection molding is a plus
  • 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 with a minimum of 3 years of related engineering experience
APPLY NOW  – or email Careers@Cirtecmed.com

Tool Maker | 2nd Shift

Summary:

To develop tooling that ensures the Cirtec Medical product is of the highest quality possible.

Responsibilities:

  • Assists in design of fixtures for Wire and plunge EDM, Lasers, Swiss machines, inspection and other machining centers
  • Fabricates fixtures from start to finish
  • Develops programs for machining centers to manufacture complex parts in multiple part holding fixtures and to include testing and proving out program and fixtures
  • Ability to design tooling as required by components or assembly drawings
  • Works with other team leaders to provide customer support for their department
  • Ensures cleanliness of the tool room and proper maintenance of the equipment
  • Continually seeks out new and better means of tooling to increase the team’s productivity
  • Quotes fixturing and tooling for engineering

Requirements:

  • Ability to program CNC machining centers using Virtual Gibbs software or Master Cam
  • Self-motivated
  • Ability to work with others, promoting good morale
  • Excellent machinist
  • Ability to produce prototype R&D projects
  • Pro E and/ or Solidworks programming capability
  • Ability to use all toolroom equipment
  • Quick decision maker and capable of working independently
  • Ability to do repair work
APPLY NOW  – or email Careers@Cirtecmed.com

Cleanroom Quality Inspector

Summary:

The Cleanroom Quality Inspector ensures that all Cirtec Medical products meet requirements for both visual and mechanical inspections as required based on print and inspection plans.

Responsibilities:

  • Performs visual inspections with microscopes at specified magnification and with a Visual Measuring System
  • Performs mechanical inspections using drop indicators, calipers, micrometers, profilometers, multimeters, pin gages, thread gages and thread rings
  • Deciphers blueprints and inspection plans to fully understand customer quality requirements
  • Attains knowledge of all Cirtec Medical procedures, work instruction and forms related to the job process
  • Maintains a clean and orderly work area on a consistent basis
  • Communicates the quality status of all styles to the Inspection Lead
  • Reads and follows Cirtec Medical handbook and maintains an attendance and tardiness record within the set limits of company policy
  • Uses Visual Measuring System and develops required statistical data
  • Other tasks as assigned

Requirements:

  • Minimum of two years final inspection experience (cleanroom setting preferred)
  • 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 skills
APPLY NOW  – or 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:

  • Establishes and maintains 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
  • Establishes and maintains 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
  • Ensures the calibration system is well documented to ensure equipment is calibrated on a routine schedule and are traceable to national standards when applicable
  • Coordinates calibration onsite service calls
  • Assists the quality department in developing and maintaining the ISO procedures and work instructions
  • Adheres to Cirtec operational procedures to maintain ISO and FDA compliance
  • Ensures effective gage planning and procurement while being aware of cost impact and maintaining budget spending
  • Ensures 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)
    • Maintains the calibration system and ensures no equipment is used beyond the recommended calibration period
    • Ensures all equipment is marked stating the status of calibration. If calibration is not required, the equipment will maintain a sticker stating reference only.
  • Creates Gage kits for Manufacturing Teams within two days
    • Works with Engineering and Manufacturing teams to create Gage Kits for long running manufacturing jobs within two days of request
  • Ensures gages are procured and received prior to start of production
    • Reviews released jobs and ensures gaging is ordered and received prior to start of production
  • Decreases the cost of Calibration
    • Continually looks at ways to save money
    • Requests quotes for procured equipment
    • Schedules multiple on-site calibration at same time to reduce cost
  • Develops time saving Inspection Methods
    • Enhances capabilities, by leveraging automation, fixturing, etc., and be more efficient with inspections, while still maintaining a high level of quality
  • Trains and coaches employees on all inspection, measuring, and test equipment and other courses as they are created
  • Communicates the quality status of all styles to leadership team
  • Provides quality leadership and expertise to teams
  • Actively promotes an environment that focuses on customer quality, continuous improvement and teamwork
  • Represents QA on project teams
  • Participates in internal, regulatory, and supplier quality audits
  • Participates in Material Review Board (MRB), as needed
  • Other tasks as assigned

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  – or email Careers@Cirtecmed.com

Tool Designer

Summary:

Provide support to engineering, production, and quality while adhering to quality system requirements. This position is responsible for developing and improving tooling and fixtures from concepts and sketches into drafting prints while complying with industry drafting standards. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Generates 3D models and Engineering drawings
  • Creates detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer
  • Reviews engineering drawings to ensure adherence to specifications and standards
  • Performs dimensional stack-ups, making adjustments as needed for best-fits
  • Manages workload to support various departments
  • Reviews external customer CAD files for drawing requirements and modifies as needed to support internal customers
  • Initiates and or reviews ECO’s for Drawing releases and revisions
  • Works effectively with other departments to resolve drawing discrepancies
  • Works with product development teams to ensure compliance when transferring documents to production releases
  • Maintains strict adherence for multiple CAD file relationships, models, assemblies, libraries and symbols
  • Maintains compliance to procedures and regulatory requirements
  • Understands and follows safety policies and practices, attend safety training and wear PPE as required
  • Other duties as assigned

Requirements:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 3 plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to drafting and tool design
  • Proficiency with Solidworks required with Pro-E/CREO experience
  • Solid working knowledge of dimensioning and Geometric tolerances, GD&T
  • Blueprint reading
  • Computer skills associated with Microsoft software
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Possess team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong mechanical aptitude
  • PDM file management experience preferred
  • Associates degree in an Engineering discipline or related field
APPLY NOW  – or email Careers@Cirtecmed.com

Quality Inspector | 2nd Shift

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 – or email Careers@Cirtecmed.com

Sales Operations Coordinator | Can be based in MN or CT

Summary:

The Sales Operations Coordinator has the primary responsibility for both the review and analysis of new and existing business opportunities. This includes, but is not limited to the development, tracking and communicating of quoting activities for both the Enfield, CT and Brooklyn Park, MN sites. The Sales Operations Coordinator will own the quoting process and deliver finished proposals within targeted timeframes. They will ensure Cirtec’s services are quoted accurately for device design, development, and manufacturing activities. They will create cost models and pricing strategies, and effectively communicate these metrics internally and externally.

Responsibilities:

  • Establishes the cost price on the basis of purchased components, labor, and other engineering and operational metrics for all Cirtec locations
  • Develops value-added propositions and written proposals
  • Evaluates, develops, and implements alternative manufacturing methods, sources of supply, and engineering strategies
  • Suggests a pricing strategy in coordination with Sales colleagues on the basis of the cost of goods and organizational objectives
  • Provides timely, accurate quotes for delivery to Sales and Project Managers on new or revised programs
  • Follows the quote during the steps of negotiations with the customer until the acquisition of the order (quote revisions, technical review, scope changes) in collaboration with the Sales and Program Management teams
  • Takes part in kick-off meetings, forwards and explains to colleagues in charge of the project, the elements of the proposal (technical, budget, timelines, milestones, limits of supplies, and delivery)
  • Works directly with customers to understand their processes and develop the best solutions for their requirements. Occasional travel may be required
  • Provides input for corporate budgets and capital equipment acquisition
  • Communicates with cross functional personnel and executive management with equal effectiveness and professionalism

Requirements/Qualifications:

  • 4 year degree in an Engineering field, plus 5 years manufacturing engineering work experience or Master’s degree, plus 3 years manufacturing engineering work experience
  • Program or product management in a regulated industry is a plus
  • Team leadership and direct customer engagement experience
  • Medical device experience required (knowledge of implantable medical device product development, manufacturing, and cost of goods is preferred)
  • Knowledge and experience related to sourcing and quoting device assemblies
  • Excellent financial, organizational, writing and verbal skills are a must
  • Strong customer-centric mindset
  • Ability to organize many details and manage multiple priorities related to customer requirements, and organizational financial objectives
  • Strategic problem solving
  • Occasional travel (25%)
APPLY NOW – or email Careers@Cirtecmed.com

Press Room Setup / Operator

Summary:

Responsible for setting up, debugging, and operating limited types of the equipment in the Press Room, which may require supervision, ensuring quality product is manufactured in accordance with company and ISO procedures.

Responsibilities:

  • Performs a variety of moderate stamping, drawing and forming operations, which includes the use of compound, combination and some progressive dies
  • Setup a variety of different tools from simple to complex with supervision
  • Runs all types of equipment safely and smoothly, reports when rates aren’t achievable and may be part of implementing changes in order to achieve quoted rates
  • Promptly watches, listens and recognizes any changes or faulty operations in any process that they have been trained on
  • Responsible for the quality of the parts they produce and following manufacturing inspection plans
  • Records statistical process controls and runs any type of inspection equipment they have been trained on
  • Able to load coils
  • Follows detailed work instructions, both verbal and written (traveler and any other)
  • Packages parts
  • Maintains a clean, organized and safe work environment
  • Performs machine maintenance, preventative maintenance and safety checks as required
  • Reads blue prints and understands basic geometric tolerances
  • Pro-actively pursues continuing education and personal development opportunities in area of expertise
  • Follows all company and ISO procedures, maintains procedures as assigned and actively participates in continuous improvement initiatives
  • Promotes a safe and positive work environment
  • Supports activities required to implement and maintain the company’s strategic and departmental objectives
  • Keeps abreast of latest in technology regarding area of expertise.  Makes recommendations to implement where feasible
  • Effectively communicates with other departments, supervisors and managers, including participation in meetings as required

Requirements:

  • High school diploma or equivalent
  • 1 to 3 years minimum experience setting up and operating automatic mechanical punch presses and various other types of equipment
  • Background in producing complex parts with tight tolerances
  • Can read prints and follow inspection instructions or procedures
  • Knowledge of statistical process controls and can record measurements on parts being produced
  • Able to operate or be trained on all types of inspection equipment
  • Ability to work well with others
  • Ability to accept responsibility and account for his/her actions
  • Ability to take care of the customers’ needs while following company procedures
  • Ability to be truthful and be seen as credible in the workplace
  • Ability to participate in needed learning activities in a way that makes the most of the learning experience
  • Ability to use thinking and reasoning to solve a problem
  • Assess own strengths and weaknesses, pursue training and development opportunities, strive to continuously build knowledge and skills and share expertise with others
  • Identify and resolves problems in a timely manner, gather and analyze information skillfully, develop alternative solutions, works well in group problem solving situations and uses reason even when dealing with emotional topics
  • Ability to pay attention to the minute details of a project, task, or work instruction
APPLY NOW – or email Careers@Cirtecmed.com

CNC Milling Machinist | Full Time, Mon - Thurs or Weekend Shift

Hours & Shifts:

  • 1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
  • 2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM
  • Weekend shift is Friday – Sunday from 6:00 AM – 6:30 PM

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:

  • Must accurately complete all department paperwork including job travelers, inspection documentation, and work packet information and tooling request forms
  • Must have a general understanding of Cirtec Medical workmanship standards
  • Must be able to maintain an acceptable efficiency operating machinery
  • Must have the ability to change most types of tooling used in various machines
  • Active participation in team meetings and improving quality programs
  • Must 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
  • Must demonstrate concern for equipment by proper use of all equipment and maintaining a clean work environment
  • Must demonstrate an ability to use inspection equipment as required, including vision systems
  • Must have the ability to solve problems to maintain quality and efficiency while working within the team
  • Must have a good attendance record
  • Must have the ability to pass internal blue print reading and workmanship tests
  • Must understand company policies and procedures
  • Must maintain a high level of quality
  • Excellent working knowledge of blueprints and geometric tolerance
  • Must interact effectively with engineering and quality individuals to solve problems that may arise in a professional and timely manner
  • Must have extensive knowledge of all phases of machining and equipment
  • Must demonstrate good decision making and problem solving
  • Continually train co-workers to encourage individual growth within the team and within the company
  • Must have the ability to set up and run all jobs within the department
  • Must promote good morale and productivity
  • Must have the ability to increase production and streamline set-ups for optimum efficiencies and quality
  • Must have the ability to trouble shoot quality problems by effectively utilizing process control and corrective actions
  • Must 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 – or email Careers@Cirtecmed.com

In-Process Inspection/Deburring | 1st or 2nd Shift

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:

  • Identifies all burrs on part & proficiently remove them with minimal errors
  • Demonstrates the ability to read blueprints
  • Safely uses knives and other deburring tools
  • Communicates effectively with team members
  • Maintains good attendance
  • Keeps a clean and orderly work area
  • Accurately records 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 – or 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 – or email Careers@Cirtecmed.com

Swiss Machinist | Full Time, Monday - Thursday or Weekend Shift

Summary:

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

Hours & Shifts:

  • 1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
  • 2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM
  • Weekend shift is Friday – Sunday from 6:00 AM – 6:30 PM

Responsibilities:

  • Operates and sets up CNC shop equipment
  • Makes adjustments and monitors assigned equipment to ensure dimensional part integrity
  • Able to preset tooling for setups and tool breakages during normal operations
  • Maintains tooling following established tool life guide lines
  • Troubleshoots and corrects problem with minimal assistance
  • Inspects parts visually and dimensionally using basic inspection equipment and techniques to assure conformance to requirements with minimal assistance
  • Completes all applicable documentation for current operations
  • Performs preventative machine maintenance as required
  • Performs 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 – or email Careers@Cirtecmed.com

Opportunities in Enfield, CT

Senior Program Manager

Summary:

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

Responsibilities:

  • Organizes a project plan for complex projects to satisfy milestones and deadlines with required actions. Tracks and communicates project status, plans, issues, timelines, action items, and budgets internally and externally.  Serves as principal contact with clients.  Coordinates and directs site visits, conference calls, and day-to-day customer communication.
  • Coordinates 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 monitors the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommends and implements corrective actions.
  • Oversees the process of preparing new or modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Authors planning documents as required to support assigned projects.
  • Contributes to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assists business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manages resources assigned to the project team to meet project goals/milestones.  Works with management to ensure project has proper resources assigned.
  • Other duties as assigned.

Requirements:

  • Willingness to travel, if required
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with 5 years of applicable experience or equivalent.

Technical:

  • Minimum 3 years’ experience in project engineering. Demonstrated ability to lead projects from early stage development to production.
  • Minimum 5 years’ experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

Training:

  • On the job training as required to meet job requirements.
  • Must remain current with trends and developments in the incumbent’s engineering specialty

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear and accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems.
  • Interaction:  Must be able to communicate well verbally and in writing and work well in a team environment.
  • Versatility:  Able to respond to changing priorities with minimum disruption.  Ability to meet deadlines and manage projects across many departments.  Ability to handle multiple projects and customers at any given time.
  • Initiative:  Must be able to function with minimum supervision.
  • Leadership:  Must be able to lead discussions, teams and meetings with customers and staff related to job role

 APPLY NOW – or 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:

  • Organizes a project plan for moderately complex projects to satisfy milestones and deadlines with required actions. Tracks and communicates project status, plans, issues, timelines, action items, and budgets internally and externally.
  • Serves as principal contact with clients.  Coordinates and directs site visits, conference calls, and day-to-day customer communication.
  • Coordinates 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 monitors the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommends and implements corrective actions.
  • Oversees the process of preparing new or modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Authors planning documents as required to support assigned projects.
  • Contributes to quality, design, and development activities or acts as backup to engineers on assigned projects as required.
  • Assists business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manages resources assigned to the project team to meet project goals/milestones.  Works with management to ensure project has proper resources assigned.
  • Other duties as assigned.

Requirements:

  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with two years of relevant experience or equivalent.

Technical:

  • Experience in an engineering/manufacturing environment with mechanical, tool design and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

Training:

  • On the job training as required to meet job requirements.
  • Must remain current with trends and developments in the incumbent’s engineering specialty.

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear and accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems.
  • Interaction:  Must be able to communicate well verbally and in writing and work well in a team environment.
  • Versatility:  Able to respond to changing priorities with minimum disruption.  Ability to meet deadlines and manage projects across many departments.  Ability to handle multiple projects and customers at any given time.
  • Initiative:  Must be able to function with minimum supervision.
  • Leadership:  Must be able to lead discussions, teams and meetings with customers and staff related to job role.

 APPLY NOW – or email Careers@Cirtecmed.com

Sr. Continuous Improvement Engineer

Overview:

At Cirtec Medical, 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. Every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. 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. We are seeking an experienced Continuous Improvement Engineer to work closely with the cross functional Value Stream teams. This position will design, develop, standardize and implement Operational Excellence methods intended to continuously improve manufacturing system performance. This individual is an influencer and facilitator, with a track record of managing change. This individual is a systems thinker who solves problems by building relationships and collaborating.

Operational Excellence at Cirtec Medical

The Operational Excellence (OpEx) program at Cirtec Medical functions under the philosophy where problem-solving, teamwork, leadership and utilization of best practices are based on the Toyota Production System and result in ongoing performance improvement throughout the organization.  At its core, the Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches respectively, leading to improved products, services, processes and systems that operate at high efficiency levels.

OpEx Mission – Our mission is to constantly improve the effectiveness of the Continuous Improvement system focused on reduction of waste and variation in all business segments and locations.

OpEx Vision – Our vision includes a culture that fully embraces and supports continuous improvement initiatives throughout the organization and a business that is continuously working to improve operational performance.

Job Summary:

The Continuous Improvement Engineer is a key member of the organization. The CI Engineer is responsible for identifying and leading execution of a wide range of Continuous Improvement projects using industry best practices in Lean and Six Sigma approaches.  He/she leads, facilitates, executes, and manages projects to reduce waste and variation through use of Lean and Six Sigma tools and methodologies. He/she will utilize his/her knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project execution to identify, prioritize and recommend improvement projects that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals and standardization and implementation of initiatives intended to improve quality, cost and delivery
  • Supports productivity, quality, process efficiency, space utilization, and standardization and lead time improvement efforts for existing and new product development programs
  • Supports the philosophy of the Toyota Production System through leading standardized use of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, value stream mapping, time studies, line balancing efforts, setup time reductions, process layout and flow improvement, 5S and standard work
  • Collaborates with cross functional teams as required
  • Evaluates, designs and implements new layouts: including storage rack, conveyor, automation, and other material handling solutions for facilities
  • Leads facility kaizen and productivity projects; ensuring projects are done according to budget and timeline
  • May supervise and provide work direction to other engineers and technicians
  • Serves as a statistical resource to a manufacturing/research facility requires a mastery of basic to advanced statistical techniques
  • Serves as an engaging and collaborative teacher providing internal consulting support for use in Lean & Six Sigma tools and data mining and presentation
  • Seeks out continuous improvement opportunities, weights their value based on benefit, investment and risk, and prioritizes work, accordingly
  • Participates in project work to help customers and operators achieve sustainable results

Requirements:

  • BS degree, preferably in Industrial Engineering or related field or equivalent experience; advanced degree a plus
  • 7 to 15 years in years manufacturing experience; preferably in medical device; preferably in machining and assembly of implantables
  • Six Sigma or Lean Certification (ASQ or IASSC) preferred
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team settings
  • Be adaptable to accept new changes in the field of lean manufacturing and should remain abreast with the latest developments happening in that field
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to influence and engage others to accomplish projects
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization
  • Strong organizational abilities; multitasks, prioritizes and meets deadlines in timely manner
  • Ability to travel to sister sites (approximately 5-10%)
APPLY NOW  – or email Careers@Cirtecmed.com

General Manager

Summary:

The General Manager (GM) reports directly to the CEO.  The GM has significant outside facing responsibilities and should be known as a go-to person for medical device contract design, development, and manufacturing services.  The GM is responsible to ensure that the facility meets the commitments made to clients and makes amends for commitments missed and has overall responsibility for managing the revenue and cost elements for the assigned facility.  The GM is responsible for planning, delegating, coordinating, staffing, organizing, and decision making to meet the above two objectives.  This successful market-focused leader is a Corporate Officer and a member of the Leadership Team.

The GM provides leadership and vision to the organization by supporting the CEO with the development of long range and annual plans, and assisting with the evaluation and reporting of progress on plans as well as communicating strategic objectives to the facility.

Responsibilities:

  • Focuses resources to drive customer success and takes responsibility for commitments made to clients and makes amends for commitments missed.
  • Provides tactical direction for projects and client interactions to meet client objectives for client success.
  • Provides input to the budget process and manages revenue and cost elements to achieve profitability goals for the facility.
  • Assists business development to secure new opportunities.
  • Increases site management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; assigning accountabilities; developing a climate for offering information and opinions.
  • Assists CEO in developing strategic plan by studying technological and financial opportunities; presenting assumptions; recommending objectives.  Plays a major role in communicating values, strategies, and objectives to facility.
  • Works effectively in a collaborative fashion with the CEO on all matters pertaining to ongoing operations in the facility and to long-term growth and objectives.
  • Maintains quality services and products by enforcing and improving organization and quality standards. Collaborates with corporate staff to provide continuous improvements to policies and procedures.
  • Builds company image by collaborating with customers, government, community organizations, and employees.
  • Provides an effective voice for the company in the target community focusing on building relationships with current and potential clients, collaborators, industry organization, and technological community.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.
  • Other duties as assigned.

Requirements:

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelors degree in an engineering discipline or equivalent.

Technical:

  • Minimum 5 years successful direct engineering management experience in the development of products from early stage development through production.
  • Minimum 5 years medical device industry experience.
  • Minimum 10 years experience in a multidisciplinary engineering and manufacturing environment with thorough knowledge of early stage development through manufacturing and continuous improvement.
  • Senior executive experience, proven organizational leadership ability and accountability for overseeing and managing a team, working cross-functionally, and delivering projects on schedule and within budget.
  • Strong collaboration, mentoring, team building, and development skills.
  • Knowledge of:
    • Product development tools and procedures.
    • FDA and ISO regulations for design control and manufacture of medical devices.
    • Project management tools and methodologies
  • Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, specifications, business correspondence and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Evidence of outstanding personal values.

Training:

  • In house on the job training as required to meet job requirements.
  • Will attend technical classes and seminars as required to enhance job performance.

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear & accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction:  Must be able to communicate well verbally and in writing and work well in a team environment.
  • Versatility:  Able to respond to changing priorities with minimum disruption.
  • Initiative:  Must be able to function with minimum supervision.
  • Leadership:  Must be able to lead teams and meetings with customers and staff related to job role.

 APPLY NOW – or email Careers@Cirtecmed.com

Business Systems Manager | Can be based in CT or MN

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 – or email Careers@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

The Senior Manufacturing Engineering position develops and implements robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards. This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improves manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
  • Develops, tests and cost justifies various tools and equipment recommended for manufacturing methods.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
  • Supports required equipment qualification/process validation.
  • Troubleshoots processes when defects occur. Determine root cause and implement effective containment and countermeasures.
  • Dispositions non-conforming products and develop re-work procedures.
  • Communicates with customers regarding process improvements and production changes.
  • Represents manufacturing on cross functional teams.
  • Participates in Kaizens and drive improvement efforts.

Requirements:

Educational:

  • Bachelor’s degree in Engineering or related field required.
  • Advanced knowledge of manufacturing and assembly processes.
  • A minimum of 5-8 years of engineering experience in a Medical manufacturing environment.
  • Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling.
  • Excellent verbal and written communication skills.
  • Fluency in English.

Technical:

  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred.
  • Technical leadership experience managing engineering teams, budgets and resources throughout various design phases, development and implementation of a new products.
  • Experience working cross functionally with other disciplines including engineering, quality, planning and scheduling.
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • A practical and logical approach to problem solving using lean six sigma concepts.
  • Interpersonal, presentation and communication skills.
  • Team working and people management skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.
  • An awareness of health and safety issues.
  • Willingness to travel, if required.

Training:

  • In house on the job training as required to meet job requirements.
  • Keep up with current industry technologies by attending training courses and conferences.

Performance:

  • Decision Making and Problem Solving: Must be able to make clear and accurate decisions.
  • Analytical Problem Solving: Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction: Must be able to communicate well, both verbally and in writing, and work well in a team environment.
  • Initiative: Able to function with minimum supervision
  • Versatility: Able to respond to changing priorities with minimum disruption.
  • Leadership: Must be able to lead discussions and meetings with customers and staff related to job role.

 APPLY NOW – or email Careers@Cirtecmed.com

Quality Control Inspector | 2nd shift

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 nonconforming 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
  • Assist with statistical methods of verifying and controlling process capability
  • Provide input when required to quality planning for specific projects and products
  • Provide leadership 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
  • Other agreed duties within the Quality Department consistent with training, qualification and experience
  • Provide Quality Support for the disposition of discrepant material
  • Provide leadership to production personnel in relation to quality
  • Provide Quality Control support to Manufacturing & Engineering
  • Other duties as assigned

Requirements:

Educational:

  • Be able to read, write and speak fluent English
  • High school diploma
  • Minimum three years’ experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of five years’ experience in a manufacturing environment

Technical:

  • Certificate(s) of training related to this field of work (medical or quality assurance)
  • A minimum of three years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • 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

Competencies:

  • Decision Making and Problem Solving: Able to take action in solving problems while exhibiting judgment and a realistic understanding of issues; able to make rational and justifiable technical decisions; does not jump to conclusions inappropriately
  • Policies and Procedures: Able to conform to all established policies and procedures, log/document work activities
  • Interaction: Able to communicate well verbally and in writing and work well in a team environment
  • Analytical Problem Solving: Able to use a systematic approach in solving problems through analysis of problem and evaluation of alternative solutions
  • Interaction: Able to clearly present information through the spoken work; influence or persuade others through oral presentation in the positive or negative circumstances; listen well
  • Versatility: Able to respond to changing priorities and requirements with minimum disruption
  • Initiative: Able to function with minimum supervision
  • Leadership: Able to lead discussions or meetings related to job role and provide leadership for production personnel on quality issues
APPLY NOW – or email Careers@Cirtecmed.com

Sales Operations Coordinator | Can be based in CT or MN

Summary:

The Sales Operations Coordinator has the primary responsibility for both the review and analysis of new and existing business opportunities. This includes, but is not limited to the development, tracking and communicating of quoting activities for both the Enfield, CT and Brooklyn Park, MN sites. The Sales Operations Coordinator will own the quoting process and deliver finished proposals within targeted timeframes. They will ensure Cirtec’s services are quoted accurately for device design, development, and manufacturing activities. They will create cost models and pricing strategies, and effectively communicate these metrics internally and externally.

Responsibilities:

  • Establishes the cost price on the basis of purchased components, labor, and other engineering and operational metrics for all Cirtec locations
  • Develops value-added propositions and written proposals
  • Evaluates, develops, and implements alternative manufacturing methods, sources of supply, and engineering strategies
  • Suggests a pricing strategy in coordination with Sales colleagues on the basis of the cost of goods and organizational objectives
  • Provides timely, accurate quotes for delivery to Sales and Project Managers on new or revised programs
  • Follows the quote during the steps of negotiations with the customer until the acquisition of the order (quote revisions, technical review, scope changes) in collaboration with the Sales and Program Management teams
  • Takes part in kick-off meetings, forwards and explains to colleagues in charge of the project, the elements of the proposal (technical, budget, timelines, milestones, limits of supplies, and delivery)
  • Works directly with customers to understand their processes and develop the best solutions for their requirements. Occasional travel may be required
  • Provides input for corporate budgets and capital equipment acquisition
  • Communicates with cross functional personnel and executive management with equal effectiveness and professionalism

Requirements/Qualifications:

  • 4 year degree in an Engineering field, plus 5 years manufacturing engineering work experience or Master’s degree, plus 3 years manufacturing engineering work experience
  • Program or product management in a regulated industry is a plus
  • Team leadership and direct customer engagement experience
  • Medical device experience required (knowledge of implantable medical device product development, manufacturing, and cost of goods is preferred)
  • Knowledge and experience related to sourcing and quoting device assemblies
  • Excellent financial, organizational, writing and verbal skills are a must
  • Strong customer-centric mindset
  • Ability to organize many details and manage multiple priorities related to customer requirements, and organizational financial objectives
  • Strategic problem solving
  • Occasional travel (25%)
APPLY NOW – or email Careers@Cirtecmed.com

Laser Technician | Levels I-IV - 2nd Shift

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 III 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 III 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 Qulaity 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 – or email Careers@Cirtecmed.com

Technician II | 2nd Shift

Summary:

A 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
APPLY NOW – or email Careers@Cirtecmed.com

Opportunities in Los Gatos, CA

Director of Operations

Summary:

Responsible for the management of all manufacturing operations and related support functions, including purchasing, production planning, production operations, shipping and receiving, kitting, facilities and equipment maintenance functions, formulating and recommending manufacturing policies and programs.  Create and direct a team oriented workforce to achieve and / or exceed employee and customer satisfaction, business and profit objectives, including continuous improvement within areas of safety, reliability, cost savings, team building and personnel management. Develop and implement business plans and programs in a manner that aligns with identified objectives.

Responsibilities:

  • Development and implementation of strategic plans for efficient and cost effective manufacturing, logistics, and related operations.
  • Manages the budgets for equipment expenditures and direct/indirect labor.
  • Provide leadership for the department, staff operational areas at appropriate levels with fully qualified individuals capable of performing duties to the required level of proficiency
  • Create and nurture a continuous improvement program and culture focusing on Lean Manufacturing processes.
  • Ensure compliance with all FDA, ISO/13485 and other external/internal quality requirements as it relates to all products and services.
  • Work across departments to achieve company and departmental objectives and build teamwork. Specifically, work with other groups to achieve product and customer standards and requirements, communicating related information as necessary to the appropriate staff.
  • Identify areas in which process modifications could positively influence a reduction in operating cost and/or increased profit.  Use of specific metrics to monitor and track performance.
  • Establishes production schedules and manpower planning, based on product requirements and material supply. Review production, inventory, equipment capacity and utilization regularly. Initiate change as deemed necessary to efficiency, on time delivery, product quality or customer satisfaction.
  • Develop and maintain a thorough understanding of clients and market to ensure that services and skills align with market and/or competition.
  • Establish and maintain a positive working relationship with clients and act as a liaison to ensure their expectations are met and any requests for information are responded to in a timely manner
  • Provide leadership and direction to subordinate managers and staff. Establish performance requirements and monitors achievements. Direct multiple production shift operations through subordinate managers.
  • Acquire a strong knowledge of the production process and all associated equipment.  Be able to troubleshoot manufacturing issues and develop a self-directed team in the same activities.
  • Gain an understanding of the manufacturing process as it applies to the business software system. Review MRP / ERP system (Syteline) as to its applicability, recommending alternate systems where deficiencies are identified.  Use ERP system to fullest capabilities to improve efficiency, reduce errors, etc.
  • Responsible for directing and managing the manufacturing engineers in transitioning developmental product to sustained manufacturing phase.
  • Develop and implement Continuous Improvement projects.
  • Other duties as assigned.

Requirements:

Education:

  • BS in Engineering or Business required. MBA or advanced degree in engineering or related scientific field is a big plus.
  • Must be able to read, write, and speak fluent English

Technical:

  • Previous class 2 and preferably class 3 Medical Device experience
  • Excellent verbal, listening and written communication skills, strong management skills and strong presentation and persuasion skills are also required
  • Hands on experience with ERP systems, Syteline a plus
  • Experience with a FDA Regulated Biotech Pharmaceutical, or Medical Device manufacturer with over 10 years’ experience and a minimum of 5 in a leadership role; clear understanding of best practice within human resources and team development
  • Demonstrated ability to develop business, operational and financial strategies, plans and programs that foster the achievement of organizational objectives
  • Ability to translate broad strategies into specific objectives and action plans
  • Understanding and implementation of Lean Manufacturing Strategy
  • Demonstrated possession of in-depth and current knowledge of industry best practices and the ability to implement the same
  • Financial knowledge of budgets, cost accounting and variance analysis
  • Experience in technical report writing and verbal and oral communication skills
  • Must be able to read blue prints and interpret technical specifications and illustrations

Performance:

  • Decision Making & Problem Solving: Able to make clear, accurate, rational, and justifiable technical decisions.
  • Policies and Procedures:  Able to develop, conform to, and reinforce established policies and procedures.
  • Analytical Problem Solving: Able to use a systematic approach to problem solving through analysis of problem and evaluation to alternative solutions.
  • Interaction: Must be able to communicate well verbally, and in writing, and work well in a team environment
  • Versatility:  Able to respond to changing priorities and requirements with minimum disruption.
  • Initiative: Able to function with minimum supervision.
  • Leadership:  Able to lead discussions and meetings related to job role and provide leadership and development guidance to operations personnel.
APPLY NOW – or email Careers@Cirtecmed.com

Shipping & Receiving Clerk

Summary:

The Shipping & Receiving Clerk conducts shipping and receiving of materials, verifies and maintains accurate records of incoming and outgoing shipments according to company’s Quality System Procedures, assists with inventory control and management,  performs cycle counting, kits and issues materials to production job orders, and orders production consumable supplies as required.

Responsibilities:

  • Receives customer supplied and/or purchased materials; this includes proper labeling, storage and documenting movement of materials
  • Unpacks, examines and routes incoming shipments; rejects damaged items and records shortages
  • Performs ERP transactions necessary to track movement of goods prior to acceptance into inventory
  • Generates required documentation for domestic and international shipments
  • Kits materials from inventory based on job order requirements and approved procedures
  • Transacts distributed materials/inventory using ERP to ensure inventory accuracy
  • Monitors inventory levels of production consumables and places orders as necessary
  • Maintains adequate inventory of shipping materials and supplies
  • Places orders for R&D materials as assigned
  • Receives and processes all defective products returned for repair, investigation or credit
  • Schedules shipper/courier pickups as required
  • Maintains the work area and equipment in a clean and orderly condition
  • Follows prescribed Safety Regulations
  • Other duties as assigned

Requirements:

Education:

  • High School Diploma
  • Minimum of 3-5 years shipping/receiving experience preferably in a regulated industry
  • Fluent and literate in English

Technical:

  • Experience with computers and computer software programs. (i.e. FedEx application)
  • Ability to read and interpret technical documentation
  • Capacity to work well under pressure and take on new challenges
  • Organizational and time management skills
  • Ability to work to tight deadlines
  • Awareness of health and safety issues as they relate to the device manufacturing
  • Ability to work independently using available resources
  • Previous experience with FDA standards, ISO 13485 and GMP principles

Physical:

  • Able to lift and/or move 30 – 40 pounds

Training:

  • In house, on the job training for unique software/systems (e.g. Syteline, Master Control) to meet job requirements
  • Attend training courses as required to perform job function

Performance:

  • Decision Making & Problem Solving:  Able to make timely and accurate decisions based on available information.
  • Policies and Procedures:  Able to conform to all established procedures and work activities.
  • Analytical Problem Solving: Able to use a systematic approach to problem solving by researching and evaluating alternative solutions in a timely manner.
  • Initiative: Able to function with minimal supervision.
  • Interaction: Able to demonstrate verbal/ written communication skills when interacting in a team environment and with individuals within the organization.
  • Versatility:  Able to respond to changing priorities and timelines in a timely manner with minimal disruption.
APPLY NOW – or email Careers@Cirtecmed.com

R&D Technician

Summary:

The R&D Technician will assemble medical devices in a sterile and non-sterile environment and work collaboratively with engineering, production planning, and manufacturing departments to ensure projects are completed on time. This position requires a self-motivated individual with a strong hands-on mechanical assembly aptitude and the ability to work independently with some direction and work instruction/documentation.

Responsibilities:

R&D

  • Ability to build prototypes (adhesive and heat bonding, lamination, soldering)
  • Ability to operate small hand tools (i.e. Dremel) and basic machining
  • Assists with design verification testing and process validations

Manufacturing:

  • Ensures that all Manufacturing Process Instructions / Inspection Instructions are followed when building client products.
  • Assists sustaining engineering with equipment qualifications as required
  • Provides input regarding tools and fixtures for use in assembly, testing, and packaging as required.
  • Complies with company safety policies and procedures.

Requirements:

Education:

  • Associates Degree or minimum 3 – 5 years of experience in medical device assembly
  • Must be able to read, write, and speak fluent English

Communication:

  • Good interpersonal, written and verbal communication skills
  • Strong and resilient temperament with the ability to work with diverse workforce
  • Strong attention to detail and abilities to follow procedures in a clean room environment.

Previous Work Experience:

  • R&D experience in a controlled manufacturing environment
  • Experience with LEAN manufacturing a plus
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action(s)

Preferred Skills:

  • Soldering experience
  • Laser welding
  • Basic machine shop skills a plus
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Software Engineer

Responsibilities:

  • Develops software / firmware in C / C++ for 16 and 32 bit microcontroller / DSPs
  • Real time operating system programming
  • Develops and implements software requirements specifications and algorithms
  • Analyzes and develops sensor interface
  • Develops discrete time control and feedback systems
  • Designs and implements signal processing and filtering algorithms
  • Contributes to and reviews circuit design activities such as Analog, digital and serial peripheral interfaces
  • Develops and executes design of experiments to formally test and validate requirements
  • NI platform programming (Ex: NI RIO)
  • Matlab / Simulink algorithm design and evaluation
  • Embedded Linux RTOS (Ex: Beagle bone) based control system development
  • DSP signal processing

Requirements:

Required skills :

  • BS/MS in EE / Math / Physics / CSE
  • 10+ years experience in Product Development (R&D) (Medical Device experience preferred)
  • 10+ years experience in Embedded Real Time Operating System programming
  • Experience with User Interface programming (on PC / tablet / smart phone platforms)
  • Excellent skills in communication, time management, in-depth analysis, as well as clear, concise business writing

Preferred skills :

  • Ability to work with a wide variety of people, including Manufacturing, and QA, as required accomplishing results with little overall guidance
  • Prefer strong familiarity with Class II or Class III medical devices
  • Familiarity with lab equipment (DVMS, Oscilloscopes, function generators, etc.)
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

The Senior Manufacturing Engineering position develops and implements robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members
  • Improves manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results
  • Develops, tests and cost justifies various tools and equipment recommended for manufacturing methods
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency
  • Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions
  • Supports required equipment qualification/process validation
  • Troubleshoots processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Dispositions non-conforming products and develop re-work procedures
  • Communicates with customers regarding process improvements and production changes
  • Represents manufacturing on cross functional teams
  • Participates in Kaizens and drive improvement efforts
  • Other duties as assigned

Requirements:

Educational:

  • Bachelor’s degree in Engineering or related field required
  • Advanced knowledge of manufacturing and assembly processes
  • A minimum of 5-8 years of engineering experience in a Medical manufacturing environment
  • Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling
  • Excellent verbal and written communication skills
  • Fluency in English

Technical:

  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred
  • Technical leadership experience managing engineering teams, budgets and resources throughout various design phases, development and implementation of a new products
  • Experience working cross functionally with other disciplines including engineering, quality, planning and scheduling
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards
  • Must be able to read blueprints and interpret technical specifications and illustrations
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles
  • The ability to understand a range of engineering functions and procedures
  • A practical and logical approach to problem solving using lean six sigma concepts
  • Interpersonal, presentation and communication skills
  • Team working and people management skills
  • The capacity to work well under pressure and take on new challenges
  • Organizational and time management skills
  • Project management skills and the ability to work to tight deadlines
  • An awareness of health and safety issues
  • Willingness to travel, if required

Training:

  • In house on the job training as required to meet job requirements.
  • Keep up with current industry technologies by attending training courses and conferences.

Performance:

  • Decision Making and Problem Solving:  Must be able to make clear and accurate decisions.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions.
  • Interaction:  Must be able to communicate well, both verbally and in writing, and work well in a team environment.
  • Initiative:  Able to function with minimum supervision
  • Versatility:  Able to respond to changing priorities with minimum disruption.
  • Leadership:  Must be able to lead discussions and meetings with customers and staff related to job role.
APPLY NOW – or email Careers@Cirtecmed.com

Manufacturing Technician

Summary:

Responsible for the manufacturing and assembly of sterile and non-sterile medical devices.

Responsibilities:

  • Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System
  • Complies with all Good Documentation Practices (GDP) when completing all manufacturing or quality records
  • Insures that all Manufacturing Instructions / Inspection Instructions are followed when building client products
  • Maintains an orderly production line at all times while building client products
  • Provides input related to sustaining engineering regarding tools and fixtures for use in assembly, testing and packaging as required
  • Assists sustaining engineering and design engineering with equipment qualifications, process validations and design verification testing
  • Complies with company safety policies and procedures

Requirements:

Educational:

  • Associates Degree or minimum 3 – 5 years’ experience in medical device assembly
  • Must be able to read, write and speak fluent English

Technical:

  • Attention to detail
  • Knowledge of ISO & FDA requirements
  • Experience with LEAN manufacturing a plus
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action
  • Good interpersonal skills
  • Good written and verbal communication skills
APPLY NOW – or email Careers@Cirtecmed.com

General Referral Application

General Referral

Don’t see a position that fits your background and experience? We are always accepting applications and resumes that we keep on file. If we open a new position that better fits your background and experience we can review your general referral application.

APPLY NOW – or email Careers@Cirtecmed.com