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 Blaine, MN (Top Tool)

Draw Specialist

Summary:

New department development for deep draw enclosures and shallow draw metal forming services. Supplies a wide variety of critical components to sophisticated customers worldwide. Develops and implements initial processes, tooling, material consideration and equipment for projects of moderate/high complexity to encompass variations of enclosures. Ensures long term production platform is cost effective.  Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for products, processes, and materials. Establishes a processes and procedures around deep-drawn enclosures. Maintains professional and technical knowledge by tracking emerging trends in analytics and data visualization and by attending training and other developmental opportunities. Manages timelines, milestones and internal details to ensure timely provision of all deliverables. Demonstrates the company’s core and growth values in performance of all job functions.

Responsibilities:

  • Develop all facets, concepts and vision of manufacturing processing custom deep-drawn enclosures for customers’ battery cases, device enclosures, and electronic housings with constructing applicable implementation cost
  • Design new systems, equipment and processes for the introduction of new products
  • Establish manufacturing best practice tools and processes
  • Coordinate, set up and implement standard operating procedure for all production operations
  • Analyze and communicate the effectiveness of new initiatives
  • Draw insights and make performance recommendations based upon the data sources
  • Use quantitative and qualitative methodologies to draw insights and support the continuous growth with in specific area of the business
  • Ensure that appropriate data-driven information (reports) and customer behavior insight continuously flow to management to help improve quality, reduce cost and deliver continued growth
  • Ensuring that future production is cost effective
  • Ensure implementation and evolution of safety procedure
  • Develop and execute the yearly manufacturing plan to deliver the business objectives (production volume, manufacturing controlled cost, quality and safety
  • Establish and maintain a standard of performance for the operation
  • Insure the alignment of the manufacturing organization with the company vision, purpose and priorities
  • Ensure compliance with compliance to prescribed QMS Health and safety policies, systems and processes
  • Estimating costs and setting the quality standards
  • Establish manufacturing priorities and allocate the resources
  • Ensure compliance with environmental policies, systems and processes

Requirements:

  • Associate’s degree or equivalent experience
  • Minimum of 5-7 years’ experience within a manufacturing draw environment
  • Medical device experience has a distinct advantage
  • Experience and knowledge of medical device requirements and standards and application thereof to devices
  • Project management skills
  • Ability to fully scope and understand projects/activities
  • Building plans based on resources, cost, activity dependencies
  • Executing to plan and mitigating risks
  • Experience with titanium, platinum, and stainless steel deep-drawn enclosures
  • Very strong manufacturing engineering/process engineering background
  • Document best practices among team and with business
  • Sophisticated tool design and troubleshooting experience in metal forming business with various tool materials and manufacturing processes
  • Must have knowledge and experience working with leadership and upper management
APPLY NOW – email Careers@Cirtecmed.com

Tool & Die Maker

Summary:

The Tool and Die Maker works independently and uses complex prints and/or computerized drawings, plans, designs to construct or repair a wide variety of intricate and complex prototypes, tools, dies, jigs, gauges and fixtures to precise dimensions.

Responsibilities:

  • Read and interpret hard copies and/or computerized drawings and specifications of tools, dies, prototypes or models
  • Compute dimensions and tolerances accurately
  • Position, secure, measure and work metal stock or materials to lay out for machining
  • Operate a variety of machine tools to cut, turn, mill, plane, bore or grind in the construction or repair of tools, dies, jigs, gauges or fixtures
  • Verify machined components for conformance to specifications. Must perform skilled fitting, adjusting and/or timing as needed.  Proficient at tool debugging
  • Set-up and safely operate mechanical punch presses or other appropriate equipment in order to test completed tools, dies, jigs or fixtures for proper operation
  • Ensures that parts are completed within required tolerance, without rejection or return and within time and budget quoted for the job
  • Pro-actively pursue continuing education and personal development opportunities in area of expertise
  • Follow all company and ISO procedures, maintains procedures as assigned and actively participates in continuous improvement initiatives
  • Promote a safe and positive work environment
  • Support activities required to implement and maintain the company’s strategic and departmental objectives
  • Keep abreast of latest in technology regarding area of expertise and make recommendations to implement where feasible.
  • Effectively communicate with other departments, supervisors and managers, including participation in meetings as required
  • Serve as back up for other tool and die makers and may train other personnel as needed

Requirements:

  • High school diploma or equivalent
  • Completion of a tool and die making apprenticeship program or a combination of two to three years of trade school, tool and die making courses or five years of related experience
  • 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 get along well with a variety of personalities and individuals
  • 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 skill and share expertise with others
  • Identify and resolve problems in a timely manner, gather and analyze information skillfully, develop alternative solutions, work well in group problem solving situations and use reason even when dealing with emotional topics
APPLY NOW – 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:

  • Perform 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
  • Run all types of equipment safely and smoothly, report when rates aren’t achievable and may be part of implementing changes in order to achieve quoted rates
  • Promptly watch, listen and recognize 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
  • Record statistical process controls and run 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)
  • Package parts
  • Maintain a clean, organized and safe work environment
  • Perform machine maintenance, preventative maintenance and safety checks as required
  • Read blue prints and understand basic geometric tolerances
  • Pro-actively pursue continuing education and personal development opportunities in area of expertise
  • Follow all company and ISO procedures, maintain procedures as assigned and actively participate in continuous improvement initiatives
  • Promote a safe and positive work environment
  • Support activities required to implement and maintain the company’s strategic and departmental objectives
  • Keep abreast of latest in technology regarding area of expertise.  Make recommendations to implement where feasible
  • Effectively communicate 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 – email Careers@Cirtecmed.com

Opportunities in Brooklyn Park, MN

Continuous Improvement Engineer

Summary:

The Continuous Improvement Engineer is responsible for leading and deploying the best practices in the manufacturing organization by taking initiative to support continuous improvement in various manufacturing processes by reducing the tooling costs, improving the flow of material and setting up cycle times. He/she works towards achieving the manufacturing goals and objectives of the organization. He/she leads, facilitates, executes, and manages projects to reduce the costs significantly by implementing Lean tools, SMED, and Six Sigma tools and methodologies. He/she uses his/her expertise to identify and recommend improvements by applying the relevant principles to establishing additional capabilities: pricing, profitability, facility design, material handling equipment specification, labor management, staff planning, project execution, and support of continuous improvement initiatives.

Responsibilities:

  • Makes optimum utilization of Lean Manufacturing and Six Sigma tools to assist in preparing the feasibility studies and ensure that the costs incurred are justified
  • Evaluates various improvements that need to be done and creates value analysis and looks for ways to reduce the costs in the engineering and manufacturing applications
  • Works with enterprise business units at the operational level to drive process improvements, identifying compliance to customer service standards and strategies for consistent, repeatable, and flawless execution
  • Evaluates, designs and implements new layouts: including storage rack, conveyor, automation, and other material handling solutions for facilities
  • Implements Continuous Improvement initiatives to help ensure the continuation of streamlined processes to create a sustainable lean organization
  • Participates in project work to help customers and operators achieve sustainable results
  • Analyzes problems utilizing demonstrated proficiency of lean tools such as Standard work, Six Sigma, 5S and other lean tools. Breaks down information in a systematic and communicable manner
  • Owns the facility kaizen and productivity projects; ensuring projects are done according to budget and timeline
  • Participates in Industrial Engineering projects with minimal oversight

Requirements:

  • Bachelor’s degree, preferably in Industrial Engineering from a 4 year college or university
  • 1 to 3 years of experience; or an equivalent combination of education and experience
  • Previous experience in a manufacturing environment is preferred, experience in a medical device setting is a plus
  • Green belt or black belt
  • Be adaptable to accept new changes in the field of lean manufacturing and should remain abreast with the latest developments happening in that field
  • Extremely organized and should have the ability to identify problems and resolve them quickly
  • Strong oral and written communication skills with excellent planning and implementation skills would definitely prove to be an advantage
  • Must be self-driven with positive attitude and should be result oriented
  • Excellent analytical skills combined with good negotiation skills and proficiency in computers would be beneficial
APPLY NOW – email Careers@Cirtecmed.com

CNC Milling Machinist

Summary:

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

Responsibilities:

  • 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 – email Careers@Cirtecmed.com

In-Process Inspection/Deburring

Summary:

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

Responsibilities:

  • 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 – 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 5 Plus years’ experience of medical device process or manufacturing engineering, contract manufacturing is a plus
  • Exposure with bonding techniques. I.E. – adhesives, chemical, laser, resistance welding
  • Familiarity with biocompatible materials
  • Experience with Pro-E / CREO and or SolidWorks with GD&T exposure required
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English.
  • Excellent reading, writing, communication, and organizational skills.
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Strong desire to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline
APPLY NOW – email Careers@Cirtecmed.com

Swiss Machinist Level-III/Shift Lead

Summary:

Motivate self and shift personnel to meet production and quality goals and objectives.  Provide complete, timely, and informative communication between other shift leads.  Ensure that Production Control schedule is followed and contribute to all teams reaching monthly sales and quality goals. Must understand the job requirements of the team manager and be able to maintain the department in their absence.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms
  • Excellent working knowledge of blueprints and geometric tolerance
  • Must have extensive knowledge of all phases of machining and equipment
  • Must demonstrate good decision making and problem solving
  • Must have the ability to set up and run all jobs within the department
  • Must have the ability to increase production and streamline set-ups for optimum efficiencies and quality
  • Must have the ability to troubleshoot quality problems by effectively utilizing process control and corrective actions
  • Shift Lead may spend up to 70% of time on a machine and 30% in Lead platform when required
  • Must have exceptional communication skills and work well with people
  • Must provide leadership to the teams on all shifts and interrelate well with all areas of the company
  • Must effectively resolve all problems that arise or seek assistance in a timely manner
  • Must understand company policies and procedures and ensures the team follows them
  • Must assist in maintaining schedules of machines to best meet customer requirements
  • Must perform duties in a manner to promote good team and company morale
  • Must demonstrate responsibility for company efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety, and continually strives for process improvements
  • Must continually mentor co-workers to encourage individual growth within company
  • Must develop a complete knowledge of management software as it pertains to the shop by supporting Production Control and tool crib. Printing routers, IP’s, and blue prints when needed
  • Emergency Coordinator for off shifts by initiating proper response to all kinds of emergency situations.  Handling employee safety and building needs
  • Responsible for all employee and building issues including security. Contacting Cirtec Management and / or Building services as needed
  • Responsible for recommending disciplinary action to Team Manager and handling  employee discipline in a professional manner as per company guidelines
  • Responsible for weekly and monthly platinum machine cleanout and control of platinum inventory
  • Responsible for assisting teams to achieve 100% monthly shipping goals, quality goals, and team goals

Shift Lead Authority:

  • Handles employee discipline in a professional manner as per company guidelines
  • Assists in all department functions
  • Assists programmers with new and better means of productivity
  • Responsible for all quality and productivity within the department
  • Responsible to meet or exceed team budgets and goals
  • Develops performance reviews and make recommendations

Requirements:

  • Minimum of 2 years supervisory experience
  • Minimum of 5 years’ experience with set ups and troubleshooting
  • Mechanical medical machining background a preferred
  • Team membership and leader training
  • Read ISO procedures that apply to this position
  • Strong blue print reading skills
  • Strong problem solving skills
APPLY NOW – email Careers@Cirtecmed.com

Quality Inspector - 3rd 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 – email Careers@Cirtecmed.com

Engineering Document Control

Summary:

Provide support to engineering, production, accounting, sales and quality while adhering to the quality system requirements. This position is responsible for initiating, improving and maintaining the engineering documentation system and contents while identifying continuous improvement projects pertaining to the engineering document system. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Manages the day-to-day requirements of the engineering documentation system, through:
    • Engineering Change Orders
    • Manufacturing Change Requests
    • Deviations
    • External standard control (i.e. ASTM, ISO)
    • Records Management
    • Documentation Life Cycle (creation, revision, obsolescence)
  • Provides training and guidance
  • Works with product development teams to ensure compliance when transferring documents to the Engineering Document System, makes recommendations to properly structure, develop and transfer the documentation
  • Utilizes on site systems to control hard and electronic copies of documents for example: Item Masters, BOM’s, Routers, Travelers, Manufacturing Change Requests, Device Master Records, Inspection Plans, External Standards
  • Identifies improvements for coordinating usage of the documentation systems
  • Creates and maintains processes for documentation system requirements
  • Represents Engineering Documentation needs in cross functional teams as assigned
  • Maintains compliance to procedures and regulatory requirements
  • Understands and follows safety policies and practices, attend safety training and wear PPE as required
  • Maintains and prepares project plans to satisfy timeline requirements
  • Performs Corrective and Preventative Action tasks
  • Miscellaneous items may include: System Log Maintenance, ECO Creation, Engineering form(s) and Template(s) control, BOM entries, ERP System data entry, Creates/designs forms for improving data accuracy and ease of entry, reviews and finalizes pre-release documentation
  • Other duties as assigned

Requirements:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices related to documentation control
  • Strong 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
  • Proven history of pursuing and driving changes
  • Associates degree in an Engineering discipline or related field
APPLY NOW – email Careers@Cirtecmed.com

Design Quality Engineer

Summary:

This position will be responsible for product remediation gap analysis and maintenance of the remediation process throughout the organization. Remediation engineering activities for selected products includes review and gap assessment of design requirements, risk management, standards, component and system level specifications, test method validation, component/contract manufacturer qualification and process validation.

Responsibilities:

  • Execute a risk based approach/procedure/plan for remediation of design requirements/specifications, technical standards, test methods, supplier controls and manufacturing controls grounded in FDA requirements and technical standards
  • Work closely with both internal groups and external groups to assess and potentially redefine or clarify system level requirements, Use-Conditions and risks for project
  • Responsible for the assessment of technical standards, labeling and technical file requirements to characterize gaps
  • Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications
  • Perform requirements flow down analysis on critical to quality product performance specifications down to components and process
  • Apply Design for Reliability and Manufacturability tools and techniques to remediation projects as appropriate
  • Provide effective support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations
  • Prepare or direct the preparation of oral and written reports of gap analysis as required by the project or department management
  • Prepare trade-off studies and implementation alternatives to mitigate gaps
  • Perform required training and certifications to demonstrate compliance with applicable divisional and corporate policies in accordance with individual training matrix
  • Collaborate with management to ensure effective and robust risk management for products and processes
  • Utilize quality systems expertise by assisting in continuous improvement activities throughout the organization as driven by product lifecycle management considerations
  • Support CAPA Board meetings and assist following-up on open action items until closure
  • Support initiatives to ensure effective reporting of quality improvement program metrics
  • Perform other duties as assigned

Requirements:

  • Bachelor’s Degree in an engineering discipline
  • 7+ years of design, quality, or reliability engineering experience in a highly regulated environment (5+ years with MS in engineering discipline)
  • 3+ years of medical device experience
  • Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations
  • Experience in the medical device industry
  • Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation
  • Knowledgeable of product development processes and methods
  • MS Degree in Engineering, Physical /Biological Sciences with RAC or CQA Certification
  • Knowledge in the application of risk management
  • ASQ Certification
APPLY NOW – email Careers@Cirtecmed.com

Director of Development

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 Director of Development leads the Advancement 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
  • Establish goals and responsibilities for development engineers, PM’s and technicians working on neurostimulation, machining, other non-cleanroom, and cleanroom-based projects
  • Develop standard methods to manufacture prototype, pre-production, and ready to transfer to production levels of cleanroom products
  • Developed detailed development schedules for all development projects
  • Work with supply chain on materials need for all programs
  • Create budgets for the development team
  • Help define manufacturing floor configurations  to provide efficient process flows
  • Identify cost reduction opportunities in manufacturing process or product design and facilitate execution of cost reduction projects
  • Maintain communications with customers regarding manufacturing project and process status
  • Provides feedback during the weekly SOP process
  • Interact with customers to provide update of status, help convey and address issues found with design or manufacturing processes
  • Provide 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 – 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:

  • Can establish the cost price on the basis of purchased components, labor, and other engineering and operational metrics for all Cirtec locations
  • Develop value-added propositions and written proposals
  • Evaluate, develop, and implement alternative manufacturing methods, sources of supply, and engineering strategies
  • Suggest a pricing strategy in coordination with Sales colleagues on the basis of the cost of goods and organizational objectives
  • Provide timely, accurate quotes for delivery to Sales and Project Managers on new or revised programs
  • Follow 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
  • Can take part in kick-off meetings, forward and explain to colleagues in charge of the project, the elements of the proposal (technical, budget, timelines, milestones, limits of supplies, and delivery)
  • Work directly with customers to understand their processes and develop the best solutions for their requirements. Occasional travel may be required
  • Provide input for corporate budgets and capital equipment acquisition
  • Communicate 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 – email Careers@Cirtecmed.com

Engineer - Program Manager

Summary:

This position provides program management support for the manufacture of finished devices and sub-assemblies, which may include electro-stimulation leads, minimally invasive devices and surgical device assemblies. The role will involve planning, scheduling, implementation, and tracking of projects during a products manufacturing life cycle.

Responsibilities:

  • Regularly interface with customers on their product for immediate and future requirements, with varying complexity of projects and programs.
  • Leads the project through its manufacturing stages while planning and setting milestones, typical projects may involve: customer coordination, process optimization and manufacturing improvement projects
  • Define project requirements setting achievable targets
  • Develop strategies to accommodate and manage foreseen and unforeseen risks
  • Define required resource needs at all stages of a program
  • Formulate solutions by utilizing proven problem solving methods such as DMAIC
  • Assist business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Frequently review the progress of the project team and assess for improvements
  • Develop and maintain technical documentation related to the program
  • Review internal program management systems and implement system improvements
  • Perform initial feasibility study of a proposed program’s success
  • Develops various projects/programs to facilitate transfer of product to manufacturing
  • Provide input for budgets, capital equipment acquisition and customer outputs
  • Effectively communicate program/project objectives and status to various cross functional audiences
  • Assign and monitor tasks to ensure program/project is on track, prepare periodic reports to communicate status
  • Successfully resolve internal and external customer conflicts to maintain program schedule
  • Comply with all approved processes to support the Quality Management System
  • Provide work direction to a team of engineers
  • Manage multiple programs in a structured, readily visible manner per standard Project Management practices

Requirements:

  • FDA cGMP principles and practices
  • Minimum of 5 years in Program Management and 5 years of engineering experience, within the engineering/manufacturing environment of medical devices, preferably with Neurostimulation Leads or class III devices
  • Possess balance of high level strategic and tactical thinking
  • Ability to analyze technical details, providing sound solutions
  • Highly developed skill set in project leadership practices, including ability to balance risk, influence/lead teams, and ownership of project outcomes
  • Demonstrated ability building and embedding project management techniques in an organization
  • Excellent downward, lateral and upward communication skills
  • Working knowledge of various quality disciplines, i.e.: safety, reliability and compliance
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions using sound data
  • Ability to learn and apply new technology
  • Familiarity with electro-mechanical medical components
  • A BS degree in relevant engineering discipline, MBA desired
  • PMP certification preferred
APPLY NOW – email Careers@Cirtecmed.com

Mechanical Design Engineer

Summary:

Defines, develops and designs medical devices and related accessories, owns efforts in developing solutions to product design, and design for manufacturability while providing functional leadership. 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 medical devices through:
    • Performing timely research
    • Transforms internal and external customer expectations into results
    • Developing full design requirements, product design, specification creation with mechanical and electrical components and assemblies
    • Creating test methods, design verification and validation activities
    • Process development, qualification and validation
    • Design and build prototype fixtures and tooling, defines equipment needs
    • Sourcing materials for prototype builds
    • Transferring to manufacturing and may support existing product lines
    • 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
  • Writes/updates work instructions, part specifications, validation protocols, and various technical documents
  • 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
  • 3+ years’ experience in the medical device industry with responsibility for materials, designs, and processes on electro-mechanical implants or external devices
  • Materials biocompatibility
  • 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 associated with medical devices
  • SolidWorks
  • 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 including statistical analysis, DOE and validation
  • Exposed to Six Sigma or process excellence tools/methodologies
  • Injection molding, extruded, and machined parts
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • A BS degree in relevant engineering discipline with a minimum 7 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 – email Careers@Cirtecmed.com

Project Engineer

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 – email Careers@Cirtecmed.com

Laser Operator

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.

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 – email Careers@Cirtecmed.com

Business Systems Manager - Can be based in MN or CT

Summary:

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

Outcome Required & Strategic Priorities:

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

Main Responsibilities / Critical Tasks:

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

Skills & Knowledge:

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

Behavioral Competencies:

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

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:

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

Requirements:

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

Opportunities in Enfield, CT

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 – 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 Bachelors 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 – 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 – email careers@cirtecmed.com

Process Development Engineer

Summary:

Works in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives
  • May serve as a primary contact with clients on projects of low to moderate complexity
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Other duties as assigned

Requirements:

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

Education:

  • Must be able to read, write and speak fluent English
  • A Bachelors degree in an engineering discipline and minimum 2 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 4 years appropriate work experience; or a minimum 7 years relevant work 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
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology
  • Technical report preparation and formal presentation skills

Training:

  • In house 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 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 discussions, teams and meetings with customers and staff related to job role
APPLY NOW – 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 – 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 – email careers@cirtecmed.com

Opportunities in Los Gatos, CA

Manufacturing Technician

Summary:

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

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System
  • Comply with all Good Documentation Practices (GDP) when completing all manufacturing or quality records
  • Insure that all Manufacturing Instructions / Inspection Instructions are followed when building client products
  • Maintain an orderly production line at all times while building client products
  • Provide input related to sustaining engineering regarding tools and fixtures for use in assembly, testing and packaging as required
  • Assist sustaining engineering and design engineering with equipment qualifications, process validations and design verification testing
  • Comply 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 – email Careers@Cirtecmed.com