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 Los Gatos, CA

Sr. Program Managers (Biomedical Engineers) (Job Code SPM)

Employer: Cirtec Medical Corporation

Responsibilities:

  • Manage development and manufacturing of Class II & Class III medical devices with electronics and embedded software in compliance with regulatory standards under IEC 60601, IEC 62366, IEC 62304, ISO 13485, ISO 14971 and FDA 21 CFR 820
  • Manage medical devices manufacturing projects, including, planning, tracking schedules, resources, budget, program progress and completion
  • Identify and manage program risks by establishing risk registers and risk mitigation plans, and formulate action plans to minimize risks
  • Create and maintain project documentation and Design History File in accordance with company procedures and applicable regulatory standards using Agile or MasterControl software
  • Manage software and hardware requirements and defects tracking using tools such as Seapine or Bugzilla
  • Conduct system verification and validation plans, draft test protocols and conduct system-level testing

Requirements:

  • Master’s degree (or foreign equivalent degree) in Biomedical Engineering or a related discipline
  • Two years of experience as a Sr. Program Manager, Program Manager, Sr. Software Verification Engineer, Programmer Analyst or a related occupation
  • The required experience must include two years of experience in developing Class III medical devices with electronics and embedded software in accordance with IEC 60601, IEC 62366, IEC 62304, ISO 13485, ISO 14971 and FDA 21 CFR 820 regulatory standards; using Bugzilla or Seapine Test Track tool; and using Agile or MasterControl software.
  • Background check required
  • Job Site: Cirtec Medical Corporation, 101 Cooper Court, Los Gatos, CA 95032
  • Hours: Full-time (40 hours per week)
APPLY NOW – or email Careers@Cirtecmed.com

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

Opportunities in Brooklyn Park, MN

Principal Design & Development Quality Engineer

Summary:

Essential responsibilities of the Principal Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Responsibilities:

  • Product / Process Development activities:
  • Author and execute Quality Plans for Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
  • Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Ensure FDA and ISO Compliance in all areas:
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide statistical data / trending analysis on CAPA, NMR and other quality metrics.
  • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Other duties as assigned.

Requirements:

Educational:

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical:

  • Minimum of 7 years of experience in a regulated manufacturing environment.
  • Experience managing/supervising other personnel preferred.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills:

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training:

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Performance:

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW – or email Careers@Cirtecmed.com

Design & Development Quality Engineer

Summary:

Essential responsibilities of the Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Responsibilities:

  • Product / Process Development activities:
  • Author and execute Quality Plans for Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
  • Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Ensure FDA and ISO Compliance in all areas:
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
  • Provide statistical data / trending analysis on CAPA, NMR and other quality metrics.
  • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Other duties as assigned.

Requirements:

Educational:

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical:

  • Minimum of 3 years of experience in a regulated manufacturing environment.
  • Experience managing/supervising other personnel preferred.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills:

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training:

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Performance:

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW – or email Careers@Cirtecmed.com

Sr. Quality Manager

Summary:

The Sr. Quality Manager will be responsible for the Leadership and management of all site-level, Quality Systems personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Quality Systems Manager shall oversee the following functions: Preventive Maintenance/Calibration, Equipment Qualifications,, CAPA / RMA (Return Material Authorization), Non-Conformance process, Document Control (ECO, Quality System and Documentation, and Internal Audit) & Supplier Quality Assurance.

Responsibilities:

  • Support the Site-level Management Representative for assurance of compliance to the Cirtec Quality Management System for the facility.
  • Provide organizational Leadership, coaching, mentoring and guidance to all Quality Systems personnel as well as cross-functional teams.
  • Drive and support Site Quality Management System initiatives.
  • Support the establishment and maintenance of site registrations (e.g. ISO 13485 and FDA).
  • Drive Quality Best Practices and cGMP within Cirtec Medical.
  • Provide guidance on the Nonconformance process and Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of associated metrics.
  • Support and manage the site Quality Systems Group to ensure functional ability to provide:
    • Quality Systems support for internal Development programs and Sustaining Manufacturing Process/Continuous Improvement efforts.
  • Support implementation and continuous improvement of processes through SPC and Process Control.
  • Support for Risk Management, component/material/process characterization and development, equipment/inspection qualification and process validation.
  • Support and oversee the Nonconformance Materials Review Board process.
    • Support for integration of new manufacturing capabilities, product transfers, development programs, and manufacturing customers.
  • Support and oversee the Site Internal Audit System.
  • Ensure Metrology and Calibration support for Quality and Operations inspection equipment.
  • Manage Supplier Quality Engineering for effective supply chain management and monitoring.
    • Support and oversee the Site-specific Supplier Audits.
  • Support Site Customer Audits.
  • Manage the Quality Systems Group to provide Documentation Control and records retention functions, Incoming/Final Inspection, Complaint Analysis, Corrective Action System and Quality Control training to Customer Focused Business Units.
  • Administration of employment practices, which may include hiring, terminating, counseling and disciplinary action for all employees. Responsible to ensure that these actions are performed in compliance with Federal and local employment laws and company policy.
  • Other duties and responsibilities as assigned.

Requirements:

Educational:

  • Minimum 4-Year degree or equivalent of directly-transferrable work experience (Engineering discipline preferred).
  • Quality and/or Regulatory certification(s) preferred (ASQ, RAPS, etc.).

Technical Requirements / Experience:

  • Minimum 5 years of experience in a manufacturing environment, with a minimum of 5 years of Leadership/supervisory-level experience, with budget and decision-making authority/responsibilities. Regulated industry/Medical Device manufacturing experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.
  • Experience in effectively managing audits by customers and regulatory agencies.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Experience with the preparation of Engineering protocols & reports.
  • Experience with the preparation, review and catalogue of SOPs, Work Instructions and other Quality Systems documents.
  • Class II and Class III Medical Device Experience.
  • Strong verbal and written communication skills. Ability to present complex data to internal and external contacts.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.

Training:

  • Cirtec Medical Quality Management Systems-specific training (to be provided).
  • Additional on-going training to meet positional/functional requirements (to be provided).

Performance:

  • Interaction: Excellent communication skills (verbal and in writing), meet with clients, as needed.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Must be able to work and thrive in a team environment.
  • Capability to interface and communicate with staff, cross-functional peers and personnel effectively.
APPLY NOW – or email Careers@Cirtecmed.com

Hardware Test Engineer

Summary:

The Hardware Test Engineer will be responsible for various engineering test functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work with a multi-disciplinary engineering team including software and hardware and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. The job requires the individual to be a team player with the ability to function well in a challenging, unconventional/untraditional, and fast paced multi-disciplinary engineering environment. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • Develop and execute procedures and tools for testing, verification, and validation of Programmable Electrical Medical Devices (PEMS).
  • Ensure that PEMS are compliant with applicable standards and requirements.
  • Develop and execute standard manufacturing tests as needed including Highly Accelerated Life Test (HALT), Highly Accelerated Stress Screening (HASS) test, Ongoing Reliability Test (ORT), RF test, and System test (ST).
  • Set up the required test beds (hardware, software and network) for PEMS.
  • Create or assist in creating assigned test automation and test software releases by executing assigned tests (manual and/ or automated) for PEMS.
  • Develop procedures and tools for testing, calibration and verification of the equipment, cooperating with the developers.
  • Conduct Route Cause Analysis when repetitive failures of company’s products occur, or failure under warranty.
  • Ensure accurate document, record and archive measurement data pertaining to product parameters and process control performance.
  • Assist and train the Equipment Test Specialists, when required, in troubleshooting and repairing returned products from the customers.
  • Participate in hardware and software design risk management activities according to applicable standards in the medical device field.
  • Work with the operations department to setup manufacturing and/or purchasing as appropriate.
  • Maintain diligent post introduction monitoring to address and customer requests for changes.
  • Read and understand technical drawings, procedures, and industry standards.
  • Perform test process verifications.
  • Ensures proper test-related documentation is completed, verified and approved.
  • Generate PCB layout guidelines and work with outside PCB layout service providers.
  • Design and build prototype PCB boards, testing fixtures, custom electronics, custom mechanical devices, & custom firmware.
  • Design and implement unit characterization tests, production tests and integration tests. Execute, analyze and verify test results.
  • Work with other engineers (HW and/or SW) to resolve issues as part of development process.
  • General manufacturing support.

Secondary Responsibilities:

  • Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical Investigator Groups, surgeons, societies, and salesforce
  • Assist in product development, integrated system testing, and manufacturing activities as required
  • Assist product development in design reviews and cadaver labs
  • Special projects and duties as assigned

Requirements:

  • 2 to 5 years of experience in testing electronic boards, modules and test equipment preferably with medical devices
  • Solid knowledge in electronics; analog, power and digital, oscilloscopes, general electronic test equipment
  • Knowledge in C, C++, Java, Java 2 Platform Micro Edition (J2ME), LabVIEW, MATLAB
  • Knowledge of Quality Control principles and methodology is an asset
  • Good Communication, interpersonal skills, analytical reasoning and problem solving
  • Experience in developing test instructions and procedures
  • Familiar with IEC 60601 and IEC 62304
  • Excellent oral, written, and presentation communication skills
  • BA in Electrical/Electronic/Biomedical/Computer Engineering
  • Ability to travel up to 15-20% of the time

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

APPLY NOW  – or email Careers@Cirtecmed.com

Sr. Electronics Engineer

Summary:

The Senior Electronics Engineer will be responsible for various engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. In addition, this individual will be responsible for coordination, and successful execution of various research projects for product development. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced multi-disciplinary research laboratory environment. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • Design and develop wireless systems for portable/low power implant systems
  • Design and develop analog and digital electronic circuits for basic sensor instrumentation
  • Design and develop PCB layouts for electronic circuits in portable/low power implant systems
  • Successfully transferring electronic circuitry design to ASIC manufacturers and testing ASIC prototypes
  • Perform design verification and validation activities to ensure designs meet specifications
  • Obtain market feedback from physicians and other customers to determine functional and design specifications for new product
  • Create and maintain project plans and Design history Files (DHF) for each project
  • Management of all aspects of project to ensure timely completion of tasks while remaining in full compliance with Cirtec quality system and other applicable regulatory bodies
  • Work with project managers to develop project schedules
  • Work with the operations department to setup manufacturing and/or purchasing as appropriate for each project
  • Maintain diligent post introduction monitoring to address and customer requests for changes
  • Research market and competition on an ongoing basis to ensure that Cirtec has cutting edge technology in neuromodulation market
  • Create reports on the status of various projects

Secondary Responsibilities:

  • Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical Investigator Groups, surgeons, societies, and sales force
  • Assist in product development and general research activities as required
  • Assist product development in design reviews
  • Special projects and duties as assigned

Requirements:

  • 5 to 7 years of electronics and wireless experience in a R&D environment preferably with medical devices
  • Experience working with Implantable medical devices, including pacemakers, cardioverter defibrillators, neurostimulators, drug pumps, physiological monitors
  • Extensive knowledge and hands on experience with analog and digital electronics in general
  • Working experience with Microcontrollers – both hardware and software development using TI MSP430/432, 8051 based, etc; Knowledge about FPGA is preferred
  • Experience with RF Transceivers, implantable antenna design using simulation software such as CST Microwave Studio, wireless data transfer and low power portable telemetry systems.
  • USB peripheral devices development experience including hardware and software development.
  • Demonstrated experience with PCB layout and routing software packages such as – Altium designer, Eagle, OrCAD etc.
  • Basic knowledge of Digital Signal Processing (DSP)
  • Strong understanding of ASIC design, manufacturing, and testing
  • Basic understanding of MEMS engineering principles and applications
  • Strong computer skills in LabVIEW, MATLAB, Microsoft Office, and Microsoft Project
  • Programming: C++, FORTRAN
  • Master’s Degree in Engineering required
  • Excellent oral and written communication skills
  • Ability to travel up to 15-20% of the time

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

APPLY NOW  – or email Careers@Cirtecmed.com

Embedded Systems Software Engineer

Summary:

The Embedded Systems Software Engineer will be responsible for various engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. The job requires the individual to be a team player with the ability to function well in a challenging, unconventional/untraditional, and fast paced multi-disciplinary embedded software R&D environment. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • Develop embedded software designs for various medical device applications
  • Perform software design risk management activities according to applicable standards in the medical device field
  • Understand software requirements per standards and create software design control documents
  • Unit testing of developed embedded software including static and dynamic testing
  • Participate in design reviews and in software process development activities
  • Create and maintain project plans and Design history Files (DHF) for each project
  • Management of all aspects of project to ensure timely completion of tasks while remaining in full compliance with Cirtec quality system and other applicable regulatory bodies
  • Work with marketing and product managers to develop forecasts and market plans
  • Maintain diligent post introduction monitoring to address customer requests for changes
  • Research market and competition on an ongoing basis to ensure that Cirtec has cutting edge technology in all markets entered
  • Assist in the planning, and maintenance of a state-of-the art embedded systems research laboratory with all necessary equipment.
  • Develop embedded software life cycle plan and management for new products
  • Work with PD, Sales & Marketing, and surgeons to identify technology projects
  • Create reports on the status of various projects
  • Ensure a steady stream of peer reviewed publications and podium presentations
  • Create and build a reputation as the best spine research facility in the world
  • Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical Investigator Groups, surgeons, societies, and sales force
  • Assist in product development and integrated system testing activities as required
  • Assist product development in design reviews, animal testing and cadaver labs
  • Special projects and duties as assigned

Requirements:

  • 2 to 5 years of experience in a research environment in embedded systems software development preferably with medical devices
  • Experience with Texas Instruments and Zarlink microcontrollers, DSP, SPI
  • Extensive experience in C++, Java, Java 2 Platform Micro Edition (J2ME), Microsoft Visual Studio
  • Remarkable knowledge about Windows and Mac systems architecture, developing installer programs, executable software packages in general
  • Experience in developing Application Programming Interface (API), Graphics User Interface (GUI), WIMP, Post WIMPs
  • Demonstrated experience working with Human Interface Devices (HIDs), developing USB based interfacing software
  • Familiar with IEC 60601 and IEC 62304
  • Bachelor’s Degree in Engineering required, Masters Preferred
  • Excellent oral, written, and presentation communication skills
  • Ability to travel up to 15-20% of the time

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

APPLY NOW  – or email Careers@Cirtecmed.com

Mobile Applications Developer

Summary:

The Mobile Application Developer will be responsible for software development functions within their product lines. This includes bringing a product from idea/concept through requirements definition, design, prototyping, code development, design verification and validation. The job requires the individual to be a team player with the ability to function well in a progressive, AGILE and multi-disciplinary Medical Product R&D environment.

Responsibilities:

  • Perform product development activities in compliance with FDA Guidelines:
    • Participate in product software requirements generation.
    • Generate product design documents from requirements.
    • Generate product mobile software code to implement designs.
    • Perform product software design verification and validation activities to ensure designs meet specifications.
  • Unit testing of developed mobile software including static and dynamic testing.
  • Support integration testing as required.
  • Support product validation activities as required.
  • Support the Software Development Life Cycle producing mobile software designs for medical devices.
    • Support of existing SW Tool infrastructure:
      • JIRA, BitBucket, Jenkins, GIT, SVN.
    • Participate in continuing software infrastructure analysis and development.
      • Peer review tools
      • Software Design methods and tools
      • AGILE processes
      • Static analysis suites
  • Participate in product design reviews and in software process development activities.
  • Assist in product development and integrated system testing activities as required.
  • Special projects and duties as assigned.

Requirements:

  • Experience with full software lifecycle development process.
    • 3-5 year experience in Mobile App development preferably with data driven apps or games. Medical device experience is a plus.
  • Experience with core iOS frameworks:
    • GameKit, UIKit, CoreBlueTooth. Android experience a plus.
  • Experience in consuming RESTful services (XML/JSON).
  • Full understanding of object oriented programming and can demonstrate proficiency with MVC patterns.
  • Experience in C, Objective-C, and/or C++ development. Swift knowledge a plus.
  • Experience with version control systems, such as Git or SVN.
  • Familiarization with Agile Methodologies.
  • Deep knowledge of iOS systems architecture.
  • Experience in developing Application Programming Interface (API), Graphical User Interface(GUI).
    • Web API development a plus.
    • Bachelors in computer science, Engineering, MIS, CIS, or related field (Masters is a plus).
  • Excellent oral and written communication skills
  • Ability to travel up to 10% of the time.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

APPLY NOW  – or email Careers@Cirtecmed.com

Materials Coordinator

Summary:

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

Responsibilities:

  • Review jobs requiring materials via the ERP system
  • Issue materials to assigned jobs physically and in ERP system
  • Return materials from completed jobs physically and in ERP system
  • Perform monthly cycle count in assigned area(s)
  • Communicate any material shortages to appropriate departments as needed
  • Prepare outgoing shipments to subcontract suppliers
  • Assist Shipping team as needed
  • Assist Production Control team as needed
  • Assist Receiving as needed
  • Other duties as assigned

Requirements:

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

Sr. Engineering Technician

Summary:

The Senior Engineering Technician works in collaboration with the development engineering team. Assisting Design and Process Engineering to develop new prototypes, processes, documentation, perform experiments and develop tooling/fixturing as needed.

Responsibilities:

  • Assembles development prototypes in a timely manner, whether independently or coordinating with a larger team of operators and technicians
  • Provides candid feedback to engineering team when designs and/or processes can be improved
  • Documents settings, assembly techniques, etc. in a laboratory notebook using good documentation practices
  • Drafts initial process flows and manufacturing procedures
  • Small scale Engineering Change Order creation and execution
  • Performs training to the assembly team when programs mature in the development phases

Requirements:

  • High school diploma/GED and 5 years relevant experience; or Associates Degree or Technical Certificate and 4 years relevant experience
  • Knowledge of a specialized or technical field relevant to position
  • Understanding of basic cleanroom, measurement, and lab equipment
  • Mechanical aptitude for intricate assembly
APPLY NOW  – or email Careers@Cirtecmed.com

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 Representative

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:

  • Serve as principal contact with existing clients. Respond to client inquiries regarding scheduling and delivery, develop ways to improve client relationships.
  • Be proactive with clients with communication concerning status of their work.
  • Serve as client advocate to all departments.
  • Collect information to support the forecasting of company sales and resources across both project and production areas.
  • Support the established customer relationship management system.
  • Create sales orders in company database and related job travelers.
  • Keep client contacts and addresses updated within company database.
  • Initiate/perform 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

Material Kitter

Summary:

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

THIS POSITION WILL TRAIN ON FIRST SHIFT AND THEN TRANSFER TO 2ND SHIFT

Responsibilities:

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

Requirements:

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

Training:

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

Performance:

  • Decision Making & Problem Solving: Able to make clear and accurate decisions without jumping to inappropriate conclusions.
  • Policies and Procedures: Able to conform to all established procedures and work activities.
  • Interaction: Able to communicate well verbally and in writing and work well in a team environment.
  • Versatility: Able to respond to changing priorities with minimum disruption.
  • Initiative: Able to function with minimum supervision.
  • Safety: Work safely without presenting a direct threat to self or others.

 APPLY NOW – or email Careers@Cirtecmed.com

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

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