Careers with Cirtec – Medical Device Design, Development and Manufacturing

We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has rewarding opportunities where you can make a difference. To view all current positions and apply online, visit the Cirtec Career Center:

If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! We want to be your career choice in the Medical Device Industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.

Opportunities in Brooklyn Park, MN

Production Planner

Summary:

The Production Planner is primarily responsible for providing jobs to manufacturing areas to meet the production schedule.

Responsibilities:

  • Releases and kits jobs for manufacturing per production schedule
  • Creates and manages jobs for engineering development projects
  • Creates and manages jobs to manage non-standard requests such as rework
  • Provides support for engineering in the creation and maintenance of item masters, bills of material and routings to enable ERP planning to function correctly and to maintain ISO 13485 compliance
  • Executes Engineering Change dispositions throughout the production system
  • Provides comprehensive planning support to assigned value stream(s) including sustaining manufacturing and new product development
  • Manages entire job life cycle from creation to close for assigned value stream(s)
  • Issues purchase orders for services required on jobs
  • Coordinates with Accounting as needed to ensure correct job costing and timely billing of development projects
  • May be assigned to projects as the Supply Chain representative where appropriate
  • Communicates schedule changes with Customer Service as needed
  • Coordinates material flow priorities with Material Coordinator(s)
  • Other duties assigned

Requirements:

  • Knowledge of ISO 13485 and FDA requirements
  • Basic math skills
  • Highly detail-oriented
  • Knowledge of inventory control concepts
  • Consistent Customer service focus
  • Computer skills (Microsoft Office Products)
  • M2M or Equivalent ERP/MRP system experience
  • Good communication skills
APPLY NOW  – or email Careers@Cirtecmed.com

Principal 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:

  • Responsible for product system design and ensuring that products developed meet both internal and external customer requirements
  • Utilizes design development, analysis and statistical tools, including SolidWorks, Minitab, and statistical methods, including DOE, Measurement System Analysis, Variable Gage R & R, Process Capability and Confidence & Tolerance interval analysis
  • Provides regular status updates to management and or customer.
  • Provides work direction to team members that may include other engineers or technician level team members
  • Owning and/or participating in DFMEA, PFMEA, and Risk analysis activities
  • Performs design reviews and pre-validation assessments
  • Works with business development to review and evaluate new opportunities and provide technical assessment of risk
  • Writes/updates work instructions, part specifications, mechanical drawings, and various technical documents

Requirements:

  • 7 or more years of experience in the medical device industry with responsibility for materials, designs, and processes on electro-mechanical implants or external devices
  • SolidWorks experience
  • Excellent reading, writing, communication, and organizational skills.
  • Experience/Expertise in experimental techniques including statistical analysis, DOE and validation
  • A BS degree in relevant engineering discipline
APPLY NOW  – or email Careers@Cirtecmed.com

Sr. Process Engineer - Development

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
    • Process development and documentation
    • Clinical Builds
    • Process Validation
  • Planning and executing process characterization activities, through tools i.e. design of experiments
  • Develops and executes IQ, OQ and PQ protocols and reports
  • Operator training
  • Process Failure Mode Effects Analysis
  • Equipment selection and implementation
  • Design, develop, and implement fixturing to assist with medical device assembly
  • Qualify fixturing and manufacturing equipment
  • Assembly and 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 lowering 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, Bill of materials, routings, fixturing, etc.
  • 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
  • Familiarity with biocompatible materials
  • Exposure to 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

Manufacturing Coordinator

Summary:

Assist in leading teams in a manner to maximize production, manage team production, Quality, and day-to-day functions. To be self-motivated. To ensure the product is done on time maintaining the highest quality possible and produced to meet production standards.  To follow the department budget and is responsible for team to strive to meet company and department goals. Effectively plans and implements work for production ensuring parts, materials, and manpower are available for the shop to perform the work.  Coordinates engineering changes into production when appropriate. Provide daily count sheet of part location for production meeting. Provides other support to production and management as required.

Responsibilities:

  • Assists Team Managers in promoting efficiency and quality within the company by generating reports to assist in managing teams to meet monthly build goal profitably in accordance to Cirtec Corporate goals (efficiency report set up and production, team quality reports, team indirect labor hours report, team overtime hours report, rework hours and cost report, production schedule reports, cost of goods, and team Sales goal
  • Performs daily physical part counts for components and assemblies within assigned departments
  • Responsible for all part movement into and out of assigned departments
  • Performs split lots when required to meet customer demands and or expectations per procedure
  • Processes all ECO dispositions for assigned departments within 24 hours of release
  • Communicates with Customer Service/Production Planning on shipment delivery dates, and provides information as to why a scheduled delivery date can’t be met
  • Coordinates with scheduling by maintaining work center schedules in accordance with established timing standards relative to machine capacities, speeds and feeds, tooling applications, setup time and other factors
  • Confers with manufacturing personnel to obtain information; assists with resolving schedule problems to expedite production operations
  • Generates daily labor reports and enters correction into Shop Floor Manager and Made 2 Manage on a daily basis to ensure accurate costing to jobs
  • Assists in entering Predator information on a daily basis to ensure accurate machine utilization.  Prepares charts to monitor machine utilization to achieve Cirtec Corporate goals.
  • Effectively assists to resolve all problems that arise with the Team Manager of assigned departments, or seeks assistance in a timely manner
  • Assists in leading/driving continuous improvement activities, including participation with and/or facilitating Kaizen activities and events using lean manufacturing principles and practices
  • Ensures 100% compliance in paper work accuracy within assigned departments
  • Sorts and closes all manufacturing related job documents and file appropriately for all teams
  • Assists in the preparation of performance evaluation packets for Team Managers when requested
  • Maintains PTO schedules and file accordingly to ensure proper machine utilization is being met to achieve goals
  • Assists Team Managers with all department training utilizing Master Control
  • Assists in providing leadership to the teams and interrelates well with all areas of the company
  • Knowledge of manufacturing, quality control, and planning processes
  • Strong interpersonal, presentation, and communication skills
  • Strong organizational and time management skills
  • The capability to work well under pressure and the capability to take on new challenges
  • Understands company policies and procedures and ensures the team members follow them
  • Working familiarity with supporting documents including, ECN’s, process deviations, non-conforming material control, ship-hold notifications, and typical associated quality related documents and records
  • Performs duties in a manner to promote good department morale with the team concept
  • Develops a complete knowledge of management software as it pertains to the shop
  • Capability to function independently with minimum/no supervision
  • Other duties as assigned

Requirements:

  • 3-4 Years of Manufacturing Experience
  • Basic Blue Print Reading
  • Basic Inventory Control
  • Good Communication Skills
  • Basic Understanding of Purchasing Processes
  • Basic understanding of Engineering functions
  • Basic understanding of Inspection functions
  • 2 Years M2M or Equivalent System Experience
APPLY NOW  – or email Careers@Cirtecmed.com

Tool Crib Coordinator - 2nd Shift

Summary:

Inventory control, receiving, and distribution of tooling and designated supplies.

Responsibilities:

  • Maintains inventory control for all tools and designated supplies using low order points, safety stock, and other reports as needed
  • Responsible for pre-locating tools for upcoming jobs, and returning of tools from previous jobs
  • Manages tooling inventory levels, sets goals and implements actions to achieve goals
  • Working familiarity with supporting documents including, ECN’s, process deviations, non-conforming material control, ship-hold notifications, and typical associated quality related documents and records
  • Complies with ISO procedures for inventory control
  • Creates work orders for internally manufactured tools, when low order points are reached
  • Performs monthly cycle counts, and prepares report using current operating software
  • Responsible for reviewing low order points and adjusting based upon demand
  • Capability to function independently with minimum/no supervision
  • Performs duties in a manner to promote good department morale with the team concept
  • Capability to work well under pressure and the capability to take on new challenges
  • Knowledge of manufacturing, quality control, and planning processes
  • Other duties as assigned

Requirements:

  • 3 – 4 years of manufacturing experience
  • Basic blue print reading
  • Basic inventory control skills
  • Good communication skills
  • Basic understanding of purchasing processes
  • Basic understanding of engineering functions
  • Basic understanding of inspection functions
  • 2 Years of M2M or equivalent MRP system experience
APPLY NOW  – or email Careers@Cirtecmed.com

Quality Control Technician

Summary:

The Quality Control group, supporting manufacturing, is responsible for ensuring that all products produced at the site meet or exceed customer requirements, specifications and expectations for Quality. This is accomplished through consistent monitoring, oversight of execution, and coaching activities for the following production operations:  Incoming inspection of materials; packaging; In-process and post-process inspection of WIP materials; acceptance for Inventory; and shipment from Finished Goods.  The Quality Control group utilizes systemic controls and support systems for this purpose to include, but not limited to: Measurement Equipment Calibration & Control; Materials Identification & Traceability; Internal Auditing; Corrective and Preventive Actions; and Control of Nonconforming Materials.

Responsibilities:

The Quality Control group is responsible for performing a number of activities associated with manufacturing operations verification checks as part of active process monitoring for assurance of Quality:

  • Performs required Quality checks and log applicable data
  • Manages batch retains for inventory and performs retain verification and Quality checks as needed
  • Identifies nonconforming materials and facilitates related actions per system requirements
  • Attends shift production meetings to understand production priorities and incorporates them into daily scheduled activities in a manner that maximizes commitment to customer delivery
  • Maintains and catalogs production data, from process monitoring activities, into database
  • Monitors indicators for Quality of product in all areas for all manufacturing operations in the facility
  • Generates and maintains reports from Quality Check data sources
  • Actively partners with cross-functional Engineering teams and team-members to find problem solving solutions
  • Performs final production verifications/confirmations including batch/lot reconciliation to DHR records
  • Performs verification of verifications/confirmations for accuracy of final materials accountability for scrap, WIP, and final material, to include relief calculations and data entry
  • Monitors the accuracy and content of consumption error reporting on an as-needed basis, to ensure correct material control, and exception resolution as required
  • Reviews audit reports to ensure all confirmations were keyed in correctly and on the correct day
  • Executes special projects as assigned by Management
  • Participates/contributes to in Continuous Improvement projects
  • Other duties and responsibilities as assigned

Requirements:

  • High School Diploma or G.E.D.
  • Technical Program / Associate Program / Advanced Education preferred
  • Strong basic Math skills
  • Experience in a manufacturing environment (Machining, Stamping, Coiling, Assembly, Laser, EDM, Secondary Operations, & Quality Controls)
  • Regulated industry (Automotive, Aerospace, Medical Device, etc.) experience preferred
  • Knowledge and experience with Quality manufacturing standards (cGMP/QSR, Good Documentation Practices, Line Clearance, Production Control)
  • Solid English verbal and written communication skills. Ability to document and explain complex scenario data to internal partners and supervisors.
  • Hands-on, self-starter with ability to work both independently as well as part of a team
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and/or database entry
  • Previous experience and/or formal GMP/QSR training preferred
  • Cirtec Medical Quality Management Systems-specific training (to be provided)
  • Additional on-going training to meet positional/functional requirements (to be provided)
APPLY NOW – or email Careers@Cirtecmed.com

Laser Operator | 1st Shift or 2nd Shift

Summary:

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

  • 1st Shift: Monday – Friday, 7:00 AM – 3:30 PM
  • 2nd Shift: Monday – Friday, 3:30 PM – 12:00 AM

Requirements:

  • Previous laser machine experience (1-2 years)
  • Experience with high tolerance cutting, welding and drilling of metals
  • Blue print reading
  • Availability to work overtime (shift and weekends)
  • Previous experience working in a cleanroom environment
APPLY NOW  – or email Careers@Cirtecmed.com

Assembler II

Summary:

Perform assembly operations according to written procedures in the clean room environment meeting all quality standards. Be familiar with and follow operating requirements including GMPs (Good Manufacturing Practices) and specific customer defined requirements.

Responsibilities:

  • Performs assembly operations per written procedures meeting both quality and productivity requirements
  • Follows verbal and written instructions of Trainers, Supervisors and Engineers
  • Actively participates in improving quality and processes
  • Demonstrates the ability to read blueprints, use a microscope and inspect all print requirements of components affected
  • Communicates effectively when problems arise or efficiencies can’t be met by yourself or other team members
  • Understands and promotes good manufacturing practices (GMPs) including all clean room related requirements
  • Interacts effectively with engineering and quality to solve problems
  • Shows self-motivation to optimize job performance on a continual basis
  • Demonstrates concern for equipment by proper use of it
  • Maintains a clean and orderly work area
  • Have good attendance record
  • Actively promotes a safe environment in the clean room
  • Looks for ways to continuously improve all aspects of the clean room
  • Is able to:
    • Diagnose and solve problems with jobs in a timely manner
    • Identify scrap and provide suggestions on how to increase yields
    • Be a back-up trainer when necessary
    • Understand production schedules and be able start the next production job
    • Maintain training records and Cirtec Medical procedures
    • Maintain accurate written, spoken and math skills on the production floor with employees and travelers
    • Troubleshoot when necessary, in a timely manner or seek assistants from trainer, supervisor or engineering

Requirements:

  • Two years minimum of microscope experience
  • Attention to detail
  • Ability to interpret written and verbal work instructions
APPLY NOW  – or email Careers@Cirtecmed.com

Programmer - Swiss

Summary:

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

Responsibilities:

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

Requirements:

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

Program Manager

Summary:

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

Responsibilities:

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

Requirements:

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

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
  • Improve existing processes for boosting productivity, quality and cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user and customer
  • Prepares Engineering Change Orders for processes, components, and Bill of materials
  • Performs and advises Corrective and Preventive Action tasks
  • Other duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more years’ experience of medical device process or manufacturing engineering
  • 2 years’ experience with bonding techniques. I.E. – Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
APPLY NOW  – or email Careers@Cirtecmed.com

Sr. Engineering Manager

Summary:

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

Responsibilities:

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

Requirements:

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

Tool Maker | 2nd Shift

Summary:

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

Responsibilities:

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

Requirements:

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

Calibration Technician

Summary:

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

Responsibilities:

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

Requirements:

  • Self-starter, ability to handle multiple priorities, and detail oriented
  • A solid understanding of blueprint reading, geometric dimensioning and tolerances, statistical process control, visual inspection tools, and mechanical measuring tools
  • Solid troubleshooting, root-cause, and continuous improvement skills
  • Excellent written and verbal communication
  • Working knowledge of Microsoft Office
  • BS, High school diploma, or GED
  • Five years of related experience
APPLY NOW  – or email Careers@Cirtecmed.com

Sales Operations Coordinator | Can be based in MN or CT

Summary:

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

Responsibilities:

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

Requirements/Qualifications:

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

Press Room Setup / Operator

Summary:

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

Responsibilities:

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

Requirements:

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

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

Summary:

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

Responsibilities:

  • Identifies all burrs on part & proficiently remove them with minimal errors
  • Demonstrates the ability to read blueprints
  • Safely uses knives and other deburring tools
  • Communicates effectively with team members
  • Maintains good attendance
  • Keeps a clean and orderly work area
  • Accurately records data on routers
  • Ability to use general shop math
  • Proficient use of a microscope at 20 power minimum

Requirements:

  • One year experience working under microscope (at 20 power minimum)
  • 6 months experience using knives and other deburring tools
APPLY NOW – or email Careers@Cirtecmed.com

Business Systems Manager | Can be based in MN or CT

Summary:

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

Outcome Required & Strategic Priorities:

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

Main Responsibilities / Critical Tasks:

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

Skills & Knowledge:

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

Behavioral Competencies:

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

Opportunities in Enfield, CT

Customer Service Agent

Summary:

Provide technical sales and customer service support to new and existing customers.  Communicate with customers and provide delivery commitments.  Respond to client inquiries regarding scheduling and delivery.  Verify pricing and process customers Purchase Orders.

Responsibilities:

  • Serves as principal contact with existing clients. Responds to client inquiries regarding scheduling and delivery, develops ways to improve client relationships.
  • Is proactive with clients with communication concerning status of their work.
  • Serves as client advocate to all departments.
  • Collects information to support the forecasting of company sales and resources across both project and production areas.
  • Supports the established customer relationship management system.
  • Creates sales orders in company database and related job travelers.
  • Keeps client contacts and addresses updated within company database.
  • Initiates/performs formal contract review as needed.
  • Other duties as assigned.

Requirements:

Educational:

  • Be able to read, write and speak fluent English
  • High School Diploma
  • Associates degree or equivalent experience in sales/customer service/job scheduling

Technical:

  • Leadership/supervision training, ability to interface and communicate with people
  • Training or equivalent experience in technical report writing and verbal and oral communication skills
  • Minimum 5 years’ experience in customer service and/or manufacturing environment

Training:

  • In-house training sufficient to demonstrate competence to meet job requirements

 APPLY NOW – or email Careers@Cirtecmed.com

Sterilization Engineer

Summary:

This position is responsible for technical execution of activities associated with projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership.

Responsibilities:

  • Leads development review and approval of sterilization validations and product adoptions
  • Provides technical support for in-house ethylene oxide and moist heat sterilization, maintaining flow of development and commercial products
  • Develops and optimizes sterilization cycles with the intent of improving cycle times, reducing lead times, and sterilization of new products
  • Oversees routine bioburden and environmental monitoring programs
  • Develops Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provides on-site training to applicable technical staff
  • Establishes preventive maintenance program for sterilization, requalification, product loading, and material handling
  • Develops and maintains knowledge of applicable industry standards for sterilization
  • Assures compliance with Federal, State and local safety/environmental regulations.  Assists in environmental testing and reporting.
  • Other duties and responsibilities as assigned

Requirements:

  • BS in Engineering; Chemical, Mechanical, Biomedical or equivalent
  • 3+ years in medical device sterility assurance, sterilization operations or testing environment
  • In depth knowledge of industrial sterilization modalities (i.e. Ethylene Oxide and Moist Heat sterilization)
  • Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA, etc.)
  • Knowledge of manufacturing and assembly processes
  • Strong leadership skills
  • Excellent verbal and written communication skills
  • Verbal and written fluency in English

Technical:

  • Previous experience with Class II Single-Use and Class III Medical devices 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
  • 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 and project management skills and the ability to work to tight deadlines and finite deliverables
  • An awareness of health and safety issues associated to sterilization manufacturing environments
  • Willingness and capability to travel, as required (estimated <5%)

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

 APPLY NOW – or email Careers@Cirtecmed.com

Quality Engineer

Summary:

Provides QE support for Engineering and Production. Interact with customers and suppliers in support of engineering projects. Individual responsibilities to be assigned at the discretion of the Director of Quality.

Responsibilities:

Projects:

  • Provides Quality Engineering support for engineering project development
  • Provides Quality Project Management support as needed for product transfers from development to validation
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination
  • Develops and maintains Validation Standard Operating Procedures
  • Develops and maintains project Quality Plan for assigned projects
  • Develops protocols, performs statistical analyses, and writes reports for validations and formal process development, which requires quality-engineering involvement such as DOEs
  • Supports the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System

Production:

  • Provides Quality Engineering support for manufacturing
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures
  • Interacts with customers and suppliers to resolve CAPA investigations and in support of manufacturing
  • Provides Quality Support for the disposition of material
  • Provides Quality Project Management Support as needed for product transfers from validation to production
  • Vendor approval and maintains and assess vendor performance data (i.e. SCAR/on time)

General:

  • Reviews and documents procedure changes for quality requirements and compliance with the quality system
  • Develops quality systems and procedures as needed
  • Audits support for third party audits, customer audits and internal audits
  • Supports the implementation of continuous improvement initiatives for production processes
  • Develops and maintains production quality control plans
  • Initiates and maintain SPC (Statistical Process Control) for production processes
  • Provides initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable
  • Complies with all work rules including those pertaining to safety, health, quality and Cirtec policies
  • Back up to Quality Systems Administrator
  • Performs other duties as necessary

Requirements:

Educational:

  • Bachelor of Science or equivalent, preferably in an engineering discipline
  • Minimum experience in medical/manufacturing environment: 2 years (BS) OR 4 years (AS) OR 7 years (ND)
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office
  • Must possess excellent verbal communication, organizational and management skills

Technical:

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

 APPLY NOW – 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
  • Supporting required equipment qualification/process validation
  • Troubleshoots processes when defects occur.  Determines root cause and implement effective containment and countermeasures.
  • Dispositions non-conforming products and develops 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 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

 APPLY NOW – or email Careers@Cirtecmed.com

Sr. 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 moderate complexity
  • Assists with preparation of proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner
  • Assists in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Tracks and communicates project status, plans, issues, timelines, action items, and budgets.
  • Provides guidance and direction to coworkers on areas of technical expertise
  • Troubleshoots production processes as required
  • Evaluates and selects appropriate test methods for product requirements
  • 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 standard
  • Must demonstrate good organizational skills
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures

Educational:

  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with 5 years of relevant experience; Associate’s degree in an engineering discipline w/10 years of relevant experience; or equivalent

Technical:

  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience
  • Strong computer skills, including the MS Office suite and MS Project
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents
  • Strong analytical skills, must be able to obtain and evaluate secondary research information
  • Ability to learn and apply new technology
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics
APPLY NOW – or 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
  • Assists with preparation of proposals and quotations for clients; interfaces as needed to resolve questions in a timely manner
  • Assists in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Has 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

Educational:

  • Must be able to read, write and speak fluent English
  • A Bachelor’s degree in an engineering discipline and minimum 2 years appropriate work experience; or Associate’s 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 
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Program Manager

Summary:

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

Responsibilities:

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

Requirements:

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

Educational:

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

Technical:

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

Training:

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

Performance:

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

 APPLY NOW – or email Careers@Cirtecmed.com

Program Manager

Summary:

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

Responsibilities:

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

Requirements:

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

Educational:

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

Technical:

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

Training:

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

Performance:

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

 APPLY NOW – or email Careers@Cirtecmed.com

General Manager

Summary:

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

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

Responsibilities:

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

Requirements:

Educational:

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

Technical:

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

Training:

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

Performance:

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

 APPLY NOW – or email Careers@Cirtecmed.com

Business Systems Manager | Can be based in CT or MN

Summary:

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

Outcome Required & Strategic Priorities:

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

Main Responsibilities / Critical Tasks:

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

Skills & Knowledge:

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

Behavioral Competencies:

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

Sr. Manufacturing Engineer

Summary:

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

Responsibilities:

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

Requirements:

Educational:

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

Technical:

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

Training:

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

Performance:

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

 APPLY NOW – or email Careers@Cirtecmed.com

Quality Control Inspector | 2nd shift

Summary:

Perform receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and nonconforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel
  • Indicate inspection status of parts with assigned labels and stamps
  • Maintain product identification and traceability
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action
  • Protect product during handling and storage in the performance of work
  • Monitor factory environmental conditions, record data and alert adverse conditions
  • Assist with distribution and control of process documentation and quality records
  • Assist with control of measuring and test equipment calibration
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action
  • Assist with statistical methods of verifying and controlling process capability
  • Provide input when required to quality planning for specific projects and products
  • Provide leadership to production personnel on quality issues
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards
  • Follow Occupational Safety and Health regulations, including laser safety practices
  • Other agreed duties within the Quality Department consistent with training, qualification and experience
  • Provide Quality Support for the disposition of discrepant material
  • Provide leadership to production personnel in relation to quality
  • Provide Quality Control support to Manufacturing & Engineering
  • Other duties as assigned

Requirements:

Educational:

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

Technical:

  • Certificate(s) of training related to this field of work (medical or quality assurance)
  • A minimum of three years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

Competencies:

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

Sales Operations Coordinator | Can be based in CT or MN

Summary:

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

Responsibilities:

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

Requirements/Qualifications:

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

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
  • Accurately documents all work performed on inspection reports and customer travelers
  • Has 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
  • Performs 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

Technician III - 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

Opportunities in Los Gatos, CA

Electrical R&D Engineer

Summary:

The Electrical R&D Engineer will be responsible for the development of electro-mechanical designs for the creation of medical device products.

Responsibilities:

  • Performs design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Performs circuit design including analog input signal conditioning, embedded control, motor control, telemetry, and inductive power coupling
  • Designs battery controlled devices
  • Designs power supplies, battery systems, power management and charging circuits
  • Designs and/or leads design of printed circuit assemblies and electromechanical assemblies
  • Trouble shoots designs and maintains engineering notebook
  • Specifies and/or designs embedded software and firmware for test and verification purposes
  • Develops electronic and electromechanical system requirements (specifications) and development plans
  • Interfaces with and manages suppliers to fabricate prototype and final design components
  • Participates in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Builds, tests, debugs, and maintains configuration of prototype assemblies
  • Develops and executes formal design verification tests
  • Develops documentation of specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Creates and releases medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Participates in the development of quality inspection and manufacturing process instructions for electronic assemblies

Requirements:

  • Minimum BS/MS in an engineering discipline; with 5+ years’ experience in a product development role.
  • Familiarity and experience with electronic design automation tools: e.g.: schematic capture, analog and digital circuit simulation, tolerance and worst case analysis, etc.
  • Experienced in at least two of the following areas:
    • Embedded control design
    • Embedded software and firmware design
    • Power supply and battery management circuits
    • Design of Lithium Ion Battery Packs
    • Motor control: stepper, BLDC controls and position sensors
    • Analog and digital sensor interfacing and signal processing
  • Excellent communication skills both written and oral

Desired:

  • Experience with Altium Designer
  • Experience with Systems and Electronic CAD and simulation tools (e.g.: MATLAB, SPICE, Labview, etc.
  • Printed circuit layout experience
  • FPGA design experience
  • Experience within the Medical Device or a highly regulated industry.
  • Knowledge of Medical Device Verification and Validation for compliance with FDA guidance
APPLY NOW – or email Careers@Cirtecmed.com

Principal Electrical Engineer

Summary:

The Principal Electrical System Design Engineer will be responsible for the development of electro-mechanical designs for the creation of medical device products.

Responsibilities:

  • Develops electronic and electromechanical system requirements (specifications) and development plans
  • Performs design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Performs circuit design including analog input signal conditioning, embedded control, motor control, telemetry, and inductive power coupling
  • Designs battery controlled devices
  • Designs power supplies, battery systems, power management and charging circuits
  • Designs and/or leads design of printed circuit assemblies and electromechanical assemblies
  • Specifies and/or designs embedded software and firmware for test and verification purposes
  • Interfaces with and manages suppliers to fabricate prototype and final design components
  • Participates in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Builds, tests, debugs, and maintains configuration of prototype assemblies
  • Develops and executes formal design verification tests
  • Performs Failure Mode Effects Analysis
  • Develops documentation of specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Creates and releases medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Trouble shoots designs and maintain engineering notebook
  • Participates in the development of quality inspection and manufacturing process instructions for electronic assemblies

Requirements:

  • Minimum BS/MS in an engineering discipline; with 10+ years’ experience within the Medical Device* industry.  *Similar experience in a highly regulated industry along with regulatory compliance and/or systems engineering experience may be substituted.
  • Expert level skills in the practice of electronic circuit design with commercial product design experience in at least four of these areas:
    • Embedded control design
    • Embedded software and firmware design
    • Power supply and battery management circuits
    • SMBus implementation
    • Design of Lithium Ion Battery Packs
    • Motor control: stepper, BLDC controls and position sensors
  • Expertise in electronic design automation tools: e.g.: schematic capture, analog and digital circuit simulation, tolerance and worst case analysis, etc.
  • Excellent communication skills both written and oral

Desired:

  • Working knowledge of medical device international regulatory (e.g.: IEC60601-1) requirements and compliance testing
  • Knowledge of Medical Device Verification and Validation for compliance with FDA guidance
  • Knowledge of creation of Design History Files and Technical Files
  • Experience with Altium Designer
  • Experience with Systems and Electronic CAD and simulation tools (e.g.: MATLAB, SPICE, Labview, etc.
  • Printed circuit layout
  • Formal systems engineering practices: requirements management, traceability, etc.
  • Knowledge of Statistical Methods
  • Design of Experiments, Taguchi or similar design optimization methods
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

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

Responsibilities:

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

Requirements:

Educational:

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

Technical:

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

Training:

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

Performance:

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

Catheter Manufacturing Technician

Summary:

Responsible for the manufacturing and assembly of sterile and non-sterile medical devices, with focus on assembly of catheter 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
  • Ensures that all Manufacturing Instructions / Inspection Instructions are followed when building customer products
  • Maintains an orderly production line at all times while building customer 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:

Education:

  • Associates Degree or a combination of equivalent education and experience
  • Minimum 5 years of experience in medical device assembly
  • Experience with assembly of catheter devices highly preferred
  • Must be able to read, write and speak fluent English

Technical:

  • Attention to detail
  • Working 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

Operations Manager

Summary:

Responsible for all manufacturing operations and related support functions, including production scheduling, production operations, formulating and recommending manufacturing policies and programs, and continuous improvement.   Create and direct a team oriented workforce to achieve and / or exceed employee and customer satisfaction, business and profit objectives, including continuous improvement within areas of safety, quality, cost, delivery, team building and personnel management. Develop and implement business plans and programs in a manner that aligns with identified objectives.

Responsibilities:

  • Development and implementation of strategic plans for efficient and cost effective manufacturing, logistics, and related operations. Manage the budgets for equipment expenditures and direct/indirect labor.
  • Manage production staff while demonstrating leadership. Establish performance requirements and monitor achievements. Direct multiple production shift operations through subordinate managers.
  • Provide leadership for the department, staff operational areas at appropriate levels with fully qualified individuals capable of performing duties to the required level of proficiency.
  • Create and nurture a continuous improvement program and culture focusing on Lean Manufacturing processes.
  • Ensure compliance with all FDA, ISO/13485 and other external/internal quality requirements as it relates to all products and services.
  • Define targets for safety, quality, cost and delivery.  Devise strategies to achieve these targets.
  • When defects are detected, engage the workforce using root cause problem solving techniques.  Contain defects and implement countermeasures while continuing to monitor process effectiveness (Plan-Do-Check-Act).
  • Establish standard work practices for lead operators, supervisors and managers.
  • Establish visual controls and daily accountability huddles with employees.
  • Work across departments to achieve company and departmental objectives and build teamwork. Specifically, work with other groups to achieve product and customer standards and requirements, communicating related information as necessary to the appropriate staff.
  • Identify areas in which process modifications could positively influence a reduction in operating cost and/or increased profit.  Use of specific metrics to monitor and track performance.
  • Establish production schedules and manpower planning, based on product requirements and material supply. Review production, inventory, equipment capacity and utilization regularly. Initiate change as deemed necessary to efficiency, on time delivery, product quality or customer satisfaction.
  • Develop and maintain a thorough understanding of customers and market to ensure that services and skills align with market and/or competition.
  • Work with HR to develop role based curriculums, development opportunities, and maximize cross training potential of staff.
  • Acquire a strong knowledge of the production process and all associated equipment.  Be able to troubleshoot manufacturing issues and develop a self-directed team to conduct the same activities.
  • Gain an understanding of the manufacturing process as it applies to the business software system. Review MRP / ERP system as to its applicability, recommending alternate systems where deficiencies are identified.  Use ERP system to fullest capabilities to improve efficiency, reduce errors, etc.
  • Other duties as assigned.

Requirements:

Education:

  • A BS in Engineering or Business is required – MBA or advanced degree preferred
  • Must be able to read, write, and speak fluent English

Technical:

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

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

Sr. Mechanical Engineer

Summary:

The Senior Mechanical Engineer will be responsible for design and development of mechanical and electromechanical medical devices.

Responsibilities:

  • Applies engineering knowledge and skills as technical engineer for all phases of development projects
  • Participates in and often leads efforts to create product specifications and develop novel designs to meet those specifications
  • Participates in hands-on development, fabrication and testing of device prototypes
  • Generates and executes test protocols to verify functionality and generates test reports
  • Generates and maintains appropriate design and manufacturing process documentation for Design History File (DHF)
  • Often coordinates and manages other technical staff to work on specific tasks
  • Communicates directly with clients to understand project needs and present results
  • Effectively interfaces with and manages suppliers to fabricate prototypes and components
  • Participates in risk management activities, and develops and implements risk mitigation strategies

Requirements:

  • Minimum BSE/BSME with 10-20 years of experience within the Medical Device industry
  • Extensive experience with design and development of mechanical and electromechanical devices, preferably class III devices
  • Significant experience as a technical team leader
  • Experience with project management preferred
  • Must be proficient with Solidworks
  • Experience in creating and managing product requirements, writing verification test protocols and test reports, and generating manufacturing procedures
  • Experience with design for manufacturing and assembly
  • Excellent communication skills, both written and oral
  • Deep knowledge of medical device design control processes

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.  Ability to meet deadlines and manage projects across many departments.  Ability to handle multiple projects and customers at any given time.
  • Leadership: Must be able to lead discussions, teams and meetings with customers and staff related to job role.
APPLY NOW – or email Careers@Cirtecmed.com

Mechanical Engineer

Summary:

Assists in defining, designing and developing electromechanical medical devices and processes in both the development and manufacturing environment.

Responsibilities:

  • Develops 3D models and drawings using SolidWorks
  • Applies engineering knowledge and skills as technical engineer for all phases of development projects
  • Participates in hands-on development, fabrication and testing of device prototypes
  • Generates and executes test protocols to verify functionality and generates test reports
  • Generates and maintains appropriate design and manufacturing process documentation for Design History File (DHF)
  • Communicates directly with clients to understand project needs and present results
  • Works on product design, machine design, and fixture design
  • Able to build, test, and iterate designs in the lab
  • Reviews and updates product requirements, creates lab test procedures, collects test data, analyzes results and drafts engineering reports
  • Performs other R&D and engineering related tasks as assigned
  • Other duties as assigned

Requirements:

  • Bachelor’s degree in Mechanical or Biomedical Engineering with an emphasis in Mechanical Engineering
  • 2-5 years of experience within the Medical Device industry
  • Must have good fundamental understanding of mechanical systems
  • Finite Element Analysis knowledge a plus
  • Labview knowledge a plus
  • Good communication skills and ability to articulate technical problems
  • Strong Initiative and ability to work independently and in cross-functional teams
  • Legal authorization to work in the U.S.

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. Ability to work independently on multiple projects.
  • Leadership:  Must be able to lead discussions and meetings with customers and staff related to job role.
APPLY NOW – or email Careers@Cirtecmed.com

Program Manager

Summary:

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

Responsibilities:

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

Requirements:

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

Education:

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

Technical:

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

Training:

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

Performance:

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

General Referral Application

General Referral

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

APPLY NOW – or email Careers@Cirtecmed.com