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

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 – 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

Opportunities in Brooklyn Park, MN

Sr. 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

Laser Engineer

Summary:

This position is responsible for providing hands-on process development and manufacturing direction to the Laser team. To develop process for each production job, set up, and monitor production. To assist team in all areas of developing programs, tooling, fixtures, and parameters for production. Provide training to ensure production meets Cirtec’s quality and efficiency specifications.

Responsibilities:

  • Develops Laser Welding and cutting process
  • Develops CNC Program and design and tooling
  • Sets up and verifies quality of production jobs
  • Sets up production parameters and insures they are documented and maintained
  • Provides trouble shooting for production jobs
  • 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 develop laser quotations and manufacturing procedures
  • 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 other 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

Requirements:

  • Minimum five years Laser experience applicable to Cirtec projects
  • Able to program cutting and welding operations
  • Minimum two years formal Laser education or equivalent experience
APPLY NOW – or email Careers@Cirtecmed.com

Machine Operator I - Coil Winding

Summary:

To maintain simple set-ups on Coil Winding machinery and have a good working knowledge of the machine he/she is working on. This person must exhibit the ability to produce quality workmanship consistently.

Responsibilities:

  • Maintains an efficiency level of at least 100%
  • Accurately completes all department paperwork including in-process, first piece and count sheets
  • Good working knowledge of blueprints
  • Ability to change materials used to produce coils
  • Be familiar with functions of the machine including tooling and programming
  • Demonstrates concern for equipment by proper use of all equipment and maintaining a clean work area
  • Have a good attendance record
  • Demonstrates an ability to use inspection equipment as required
  • Ability to solve problems of quality and efficiency working within the team
  • Part specific procedure and machine training by the team leader is required prior to any level 1 employee operating a machine or performing an operation
APPLY NOW – or email Careers@Cirtecmed.com

Materials Coordinator - 2nd Shift

Summary:

The Materials Coordinator is primarily responsible for accurately issuing raw materials and components for jobs to support production.

Responsibilities:

  • Reviews jobs requiring materials via the ERP system
  • Issues materials to assigned jobs physically and in ERP system
  • Returns materials from completed jobs physically and in ERP system
  • Performs monthly cycle count in assigned area(s)
  • Communicates any material shortages to appropriate departments as needed
  • Prepares outgoing shipments to subcontract suppliers
  • Assists Shipping team as needed
  • Assisst Production Control team as needed
  • Assists Receiving as needed
  • Other duties as assigned

Requirements:

  • Basic math skills
  • Proficient typing skills
  • Detail-oriented
  • Knowledge of inventory control concepts
  • Customer service focused
  • Computer skills (Microsoft Office Products)
  • M2M or Equivalent ERP/MRP system experience
  • Good communication skills
APPLY NOW – or 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 – 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

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
    • Transforming 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
    • Designing and building 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 – or 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 – or 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 – 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 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 – or 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 – 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:

  • 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 – or email Careers@Cirtecmed.com

Opportunities in Enfield, CT

2nd Shift-Materials Kitter

Summary:

Job duties include kitting and issuing materials to specific job orders, tracking and ordering of production consumable supplies and assisting with shipping/receiving processes as needed. Perform backup duties for shipping receiving as required.

Responsibilities:

  • Kits materials from inventory per job order demands and documents quantities & lot numbers on documentation
  • Distributes inventories from stock by request forms and performs computer transactions to ensure inventory accuracy
  • Maintains and monitors manual or computerized inventory control system for raw materials and finished stock.  Investigates all discrepancies.
  • Monitors inventory levels on production consumables and places orders as necessary
  • Assists in day-to-day shipping receiving activities as needed and acts as backup for the shipping-receiving department as required
  • Performs miscellaneous administrative assignments

Requirements:

  • Be able to read, write and speak fluent English
  • High School Diploma
  • Experience in a manufacturing environment preferred
  • Experience and familiarity with computers, software and programs
  • Close attention to detail is required

Training:

  • In-house on the job training to meet job requirements

Performance:

  • Decision Making & Problem Solving:  Able to make clear and accurate decisions without jumping to inappropriate conclusions.
  • Policies and Procedures:  Able to conform to all established procedures and work activities.
  • Interaction:  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:  Able to function with minimum supervision.
  • Safety:  Work safely without presenting a direct threat to self or others.

 APPLY NOW – or email Careers@Cirtecmed.com

Materials Coordinator

Summary:

Job duties include inventory control, job order material usage reconciliation, job closings, and inventory reconciliation. Coordinating with purchasing and production to ensure the inventory is accurate and appropriate to meet demands.  Perform duties within the production and inventory control department as required.

Responsibilities:

  • Closes all production jobs, verifying material issues before doing so
  • Copies all documents necessary for and file into the DHR file
  • Prepares closed jobs with necessary documentation for AR invoicing
  • Provides customers with Inventory reports of their material as requested
  • Creates “customer supplied” materials purchase orders
  • Acts as the back-up for customer service to release job orders to the floor
  • Maintains and monitors manual or computerized inventory control system for raw materials and finished stock.  Investigates all discrepancies.
  • Performs cycle counts and assists with annual physical inventory as required
  • Investigates all material / inventory discrepancies
  • Supports or provides back-up to Production and Inventory Control functions as required
  • Receives delivered supplies, materials and equipment from suppliers as well as re-stocks and inspects items returned into inventory
  • Organizes and maintains warehouse and inventory areas for efficient material storage and handling, including labeling, stocking and organizing stock items on shelving
  • Operates equipment involved with issuing and stocking materials
  • Oversees all aspects of warehouse, shipping/receiving functions

Requirements:

Educational:

  • Be able to read, write and speak fluent English
  • High School Diploma

Technical:

  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system.
  • Inventory management and control disciplines
  • Computerized inventory record keeping systems
  • Warehouse/Shipping/Receiving

Training:

  • In-house on the job training to meet job requirements

Performance:

  • Decision Making & Problem Solving:  Able to make clear and accurate decisions without jumping to inappropriate conclusions.
  • Policies and Procedures:  Able to conform to all established procedures and work activities.
  • Analytical Problem Solving:  Able to use a systematic approach in solving problems by researching and evaluating alternative solutions.
  • Interaction:  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:  Able to function with minimum supervision.
  • Safety:  Work safely without presenting a direct threat to self or others.

 APPLY NOW – or email Careers@Cirtecmed.com

Manufacturing Engineering Manager

Summary:

The Manufacturing Engineering Manager will provide functional supervision to the manufacturing engineering department. The ME Manager will assist production technicians and project engineers in defining and developing processes prior to introduction into standard production and lead process improvement efforts and day-to-day support of production products.

Responsibilities:

  • Provides support & supervision to direct reports for the timely completion of projects, initiatives and key activities
  • Mentors associates and fosters a learning and growth environment.  Performs evaluations at regular intervals
  • Organizes a project plans with required actions. Tracks and communicates project status, plans, issues, timelines, and action items.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Works with technicians on developing processes and documentation for new or modified products.
  • Develops and implements process improvements for current production products.
  • Troubleshoots production processes when part failures occur.
  • Communicates with customers on process improvements and/or manufacturing changes.
  • Participates in the development of new products, work with customers to understand their requirements.
  • Leads small development projects, including process development, process validation, and documentation.
  • Prepares periodic reports on project activities.

Requirements:

  • Ability to meet deadlines and manage projects.
  • Ability to handle multiple projects at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment

Educational:

  • Must be able to read, write and speak fluent English
  • Minimum Associates degree or equivalent experience.  Preferred bachelor’s degree in an engineering discipline or equivalent.

Technical:

  • Minimum 3 years of experience in manufacturing engineering.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Above average oral and written communication skills at all levels for technical personnel and client contact.
  • Ability to work independently using available resources.
  • Must have demonstrated organizational skills to manage multiple priorities and schedule revisions.

Training:

  • In house on the job training as required to meet job requirements.

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

Sr. Quality Engineer

Summary:

Essential duties and responsibilities of Senior Quality Engineer include the activities of Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions.   Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Product / Process Development activities:
    • Develops and performs operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments.
    • Assists with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
    • Initiates the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
    • Generates the Quality Plan for development projects.
    • Provides direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
    • Creates appropriate sampling plans along with identifying inspection and acceptance criteria.
    • Reviews and/or documents Design Control activities for Project Phase Reviews and Product Verification testing as required per project requirements.
    • Performs vendor audits and qualifications.
    • Represents quality engineering in phase reviews and other aspects throughout product development.
  • Ensures FDA and ISO Compliance in all areas of Responsibilities:
    • Manages the internal audit system schedule and perform the duties of a Lead Auditor including training internal auditors.
    • Performs internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting.
    • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
    • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
    • Provides trending analysis on CAPA, NMR and other quality metrics.
    • Provides quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.
  • Other duties as assigned.

Requirements:

Educational:

  • AS/BA/BS in Quality Engineering or related discipline.

Technical:

  • Minimum experience in medical/manufacturing environment: 5 years (BS) OR 10 years (AS)
  • Extensive experience with medical device QSRs in design control and production environments.
  • Strong familiarity with Class II or Class III medical devices requirements
  • Knowledge of FDA/cGMP and MDD regulations/guidelines.
  • Experienced with ISO13485
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • PREFERRED REQUIREMENT: CQE certification

Training:

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

Skills:

  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

Performance:

  • Interaction:  Must be able to communicate well verbally and in writing with clients, as needed.
  • Initiative:  Must be able to function with minimum supervision.
  • Leadership:  Must be able to lead discussions and meetings with senior management staff.
  • Analytical Problem Solving:  Must be able to use a systematic approach to solve problems and make adjustments.
  • Must be able to work in a team environment.
  • Ability to interface and communicate with people effectively.

 APPLY NOW – or email Careers@Cirtecmed.com

Manufacturing Engineer

Summary:

The 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.  Determines root cause and implements 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.
  • Knowledge of manufacturing and assembly processes.
  • Strong leadership skills.
  • 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.
  • 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 participation 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.

 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

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

Engineering Manager

Summary:

The Engineering Manager will provide functional supervision to the engineering department, consisting of research and development engineers and technicians, and mechanical designers.  The Engineering Manager will serve as Project Manager and/or technical lead for projects including validation and documentation of new product services, and expansion of existing product services including defining requirements, timelines, and deliverables.

Responsibilities:

  • Provides support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentors associates and fosters a learning and growth environment.  Performs evaluations at regular intervals.
  • Serves as secondary contact with clients; instilling confidence in our technical capabilities and quality products.
  • Ensures team is performing under the Cirtec quality system and with good engineering practices.
  • Ensures R&D, design and tooling resources are meeting project needs in both availability and talent in a multi-project environment.
  • Ensures that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversees the process of developing new or modified products ensuring compliance to internal, regulatory, and customer requirements.
  • Provides leadership for teams that will execute projects in all aspects of the development process to include: requirement and specification definition, risk management, design development, process development, sourcing and supply chain, prototype builds, device verification testing, process qualification, and transfer into manufacturing.
  • Manages day-to-day oversight of engineering support of the manufacturing operation for assigned customers after product release as necessary.
  • Assists with preparation of proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner.
  • Other duties as assigned.

Requirements:

  • Ability to meet deadlines and manage projects across many departments.
  • Ability to handle multiple projects and customers at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on Cirtec policies and procedures.

Educational:

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

Technical:

  • Demonstrated ability to lead engineering teams successfully from early stage development to production.
  • Minimum 7 years’ experience in an engineering/manufacturing environment.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications and illustrations.
  • Technical report preparation and formal presentation skills.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

 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

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

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