Careers with Cirtec – Medical Device Design, Development and Manufacturing

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

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

Opportunities in Brooklyn Park, MN

Quality Documentation Retention Specialist

Summary:

The Quality Documentation Retention Specialist will be responsible for reviewing Quality records for accuracy, ensuring that mistakes are correctly amended, scanning all device history records, and delivering all Quality records to the Quality Documentation Assistant for storage.

Responsibilities:

  • The Documentation Retention Specialist will review production travelers for accuracy, ensuring all fields are completed, that data is accurate, and ensuring that mistakes are correctly amended.
  • The Documentation Retention Specialist will be responsible for scanning all device history records to the designated locations after all operations are completed.
  • Deliver all completed and scanned device history records to the Quality Documentation Assistant for data entry and storage.
  • Other tasks as assigned.

Requirements:

  • Familiar with Good Documentation Practices
  • Self-Starter, ability to handle multiple priorities, and detail oriented
  • Excellent written and verbal communication skills
  • Working knowledge of Microsoft Office
  • Bachelor or Associates degree preferred; High school diploma or GED required.
  • Two years of related experience
APPLY NOW  – or email Careers@Cirtecmed.com

HR Manager

Summary:

Directly responsible for the overall administration, coordination, and evaluation of the Human Resources function. Also shared responsibility for Security, Safety, Hazardous Waste and Wastewater Management. Participates in Management of Cirtec as a member of Cirtec Management Team.

Responsibilities:

  • Implements and annually updates compensation program; rewrites job descriptions as necessary; conducts annual salary surveys; monitors performance evaluation program and revises as necessary.
  • Develops, recommends, and implements personnel policies and procedures; maintains employee handbook; performs benefits administration to include claims resolution, change reporting, annual re-evaluation of policies for cost effectiveness, and communicates benefits to employees.
  • Conducts recruitment effort for all exempt and nonexempt personnel, conducts new-employee orientations; monitors training and advancement program, employee relations counseling, and exit interviewing; writes and places advertisements.
  • Maintains permanent personnel records.
  • Provides public information such as verifying employment.
  • Monitors unemployment claims and writes appeals.
  • Coordinates safety programs including acting as chair of safety committee, records OSHA Log, monitors workers’ compensation claims and coordinates communication between employee and insurance carrier.
  • Maintains complete attendance records.
  • Maintains compliance with federal and state regulations concerning employment.
  • Writes and maintains job descriptions.
  • Publicizes, manages, and monitors apprenticeship program.
  • Organizes employee events.
  • Provides education support to all employees.
  • Coordinates all benefits activities including renewals and development of alternatives to standard programs.
  • Creates and maintains wage scale. Participates in salary surveys to obtain current salary information.
  • Monitors and coordinates all Security Operations.
  • Hazardous Waste Program:
    • Responsible for hazardous waste management compliance
    • Obtain and maintain proper licenses
    • Ensure wastes are properly labeled, handled and disposed
    • Ensure weekly inspections are conducted, logged, and problems addressed
    • Ensure staff involved in hazardous waste management have proper training and maintain tracking of training
    • Track waste manifests and follow up on irregularities
    • Maintain records as required by regulations
    • Ensure emergency measures and personnel are in place
    • Provide reports to regulatory agencies as required
    • Must have appropriate training

Requirements:

  • 4 year degree plus 5 years human resources work experience or Masters degree plus 3 years human resources work experience.
  • Continued education in employment law and human resources related seminars.
  • Team leader and membership training.
  • Read ISO procedures that apply to this position.

ISO PROCEDURES TO BE TRAINED ON: 

ISO System Overview

This job description in no way states or implies that these are the only duties to be performed by the employee in this position. Employee will be required to follow other job related instructions and to perform other job-related duties requested by any person authorized to give instructions or assignments.

APPLY NOW  – or email Careers@Cirtecmed.com

IT System Administrator

Summary:

This exciting position is responsible for the operation of all hardware and end-use software for the Brooklyn Park location. This includes planning, implementing, maintaining, administering and monitoring all hardware and software, backups, VPN, network security, infrastructure and devices including but not limited to routers, firewalls, switches, servers, printers, laptops, workstations, wireless terminals, cell phones, phone systems, security systems and applications. Sounds like a lot? It is, luckily you will also be responsible for working with a small team of highly skilled individuals to accomplish all of this, so being a team player is a must-have skill!

Responsibilities:

  • Provide end user support 1st & 2nd level helpdesk support roughly 50% of the day.
  • Day to day server management – File, Print, SQL, Exchange Email, Domain Controllers.
  • Assist in management of all network hardware and equipment including HP Servers, Fortinet firewalls, HP ProCurve switches, and wireless routers in LAN / WAN environment.
  • ERP system experience and CNC Machine Shop Floor Automation a plus.
  • Setup and create test lab environments to support business justifications a plus.
  • Manufacturing, inventory, warehouse & distribution experience is a plus.
  • IT experience in a medical device environment with regulatory a plus.
  • LAN / WAN integration a plus.
  • CAD / CAM Software (Creo, Esprit, Gibbs, SolidWorks, etc) in a CNC Machine Shop with DNC environment a plus.
  • Installation, configuration, maintenance and troubleshooting of end user workstation hardware, software and peripheral devices. Create trouble tickets and handle support calls.
  • Administer and perform hardware and software upgrades.
  • Perform bare metal server installations.
  • Create and deploy virtual machines via Hyper-V.
  • Manage, monitor and resolve performance problems with Hyper-V VM’s and hosts.
  • Network device management: Manage router and switch configurations: install, configure and deploy switches and firewalls across multiple subnets and VLANs.
  • Manage and deploy windows updates via WSUS a plus.
  • Manage and create workstation images via Windows Deployment Services a plus.
  • Conduct research and provide opinions on new services/equipment/products for deployment within the company.
  • Practice asset management and related documentation and technical specifications information as requested.
  • Administer and maintain end user accounts, permissions and access rights.
  • Manage and monitor the managed backup service. Perform recovery when needed.
  • Recommend, schedule and perform network and system improvements, upgrades and repairs.
  • Perform 1st & 2nd level helpdesk support.
  • Create and log vendor support calls and assist with trouble resolution.
  • Must be available to occasionally work nights and weekends for maintenance and system upgrades.
  • SaaS private company cloud experience a plus.
  • VDI (Virtual Desktop Infrastructure) and Remote Desktop experience deploying legacy Windows XP a plus.
  • Must be available for on call support.

Requirements:

  • BA or 2 year technical degree in Computer Science or equivalent work-related experience.
  • 5+ years of experience supporting and administrating Windows servers and Windows XP, Windows 7 & 10 workstations.
  • 5+ years of Active Directory experience.
  • 3+ years of Hyper-V experience; clustered environments preferred.
  • 5+ years of hands on and over the phone troubleshooting experience.
  • Must have excellent customer service skills.
  • Must have HP Procurve experience.
  • iSCSI and Fibre Channel and SAN experience preferred.
  • Microsoft SharePoint experience is a plus.
  • Must have a positive attitude, be approachable, friendly and have a good sense of humor.
  • Knowledge of applicable data privacy practices and laws.
  • Strong problem solving abilities.
  • Strong verbal and written communication skills.
  • Strong customer service skills.
  • Ability to work as a team member and individually.
  • Ability to multitask.
  • Ability to conduct research into issues and products as required.
  • Ability to present technical concepts and ideas in user-friendly language.
  • Self-motivated and self-directed.
  • Strong attention to detail.

REQUIRED EDUCATION:

  • IT Technical School, Associate, Microsoft Certifications are a plus, or equivalent experience

REQUIRED EXPERIENCE:

  • Microsoft Windows Server LAN/WAN Environment: 3 years
  • Microsoft Exchange Server: 2 years (High Availability is a plus)
  • SaaS Private Cloud
  • Virtual Machine Environment Hyper-V
  • Active Directory: 5 years
APPLY NOW  – or email Careers@Cirtecmed.com

Software Test Engineer

Summary:

The Software Test Engineer will be responsible for writing test protocols and executing unit, integration and system level tests for active implantable and hand-held medical devices. Requires close communication with the product development team to track testing status and regression testing. This individual will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers 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. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • Review software requirements and become familiar with the software being tested.
  • Participate in product development meetings and software/hardware design and risk analysis reviews.
  • Experience in creating and executing test cases and scripts to verify software and hardware requirements.
  • Working knowledge of testing mobile applications and embedded medical devices.
  • Ensure that medical device components are compliant with applicable international standards and requirements.
  • Maintain software/hardware design history file and participate in periodic phase reviews.
  • Report defects to the stakeholders and create test logs.
  • Provide inputs to the team in order to improve the medical device design and test outcomes.

Requirements:

  • 2-5 years’ experience in testing active implantable devices, hand-held devices and test equipment used for testing medical devices.
  • Working knowledge in electronics; analog, power and digital, oscilloscopes, general electronic test equipment.
  • Knowledge of Quality Control principles and methodology is an asset
  • Good Communication and interpersonal skills
  • Analytical reasoning and problem solving
  • Experience in developing test instructions and procedures
  • Familiar with standards such as IEC 60601-1 and IEC 62304
  • Excellent oral, written, and presentation communication skills
  • Bachelor’s Degree in Electrical/Electronic/Biomedical/Computer Engineering

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. This individual will work with customers 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 communication solutions for active implantable and hand held medical devices.
  • Design and develop analog and digital electronic circuits for neuromodulation system components.
  • Develop firmware (in C or C++) for calibrating and testing prototype boards.
  • Successfully transfer electronic circuit design to ASIC manufacturer and test ASIC prototypes.
  • Perform design verification and validation activities to ensure designs meet specifications.
  • Create and maintain project plans and Design History Files (DHF) for each project.
  • Work with project managers to develop project schedules.
  • Work with the operations department to setup manufacturing and/or purchasing as appropriate for each project.
  • Research market and competition on an ongoing basis to ensure that Cirtec has cutting edge technology in neuromodulation market.

Requirements:

  • 5 to7 years of electronics and wireless experience in an active implantable medical device product development environment
  • 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
  • Working experience with Microcontrollers – both hardware and software development using TI MSP430/432, 8051 based, etc.; Knowledge about FPGA, CPLD 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, C++, C#
  • 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

Electronics Test Engineer

Summary:

The Electronics Test Engineer will be responsible for various engineering test functions associated with designing and developing active implantable devices. This includes developing test protocols and scripts, fixtures/tooling for hardware calibration and testing, design verification and validation, and developing test procedures for manufacturing. 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-motivating 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 tools for testing and execute test procedures as part of verification, and validation of active implantable and hand-held external medical devices.
  • Ensure that active implantable and hand-held external medical devices 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 setup (hardware, software and network) for active implantable and hand-held external medical devices.
  • Create or assist in creating assigned test automation and test software releases by executing assigned tests (manual and/ or automated) for active implantable and hand-held external medical devices.
  • Conduct Root Cause Analysis when repetitive failures of product occur.
  • Assist and train company personnel, when required, in troubleshooting and repairing returned products from the customers.
  • Participate in hardware and software design risk management activities according to applicable standards for a medical device.
  • Work with the operations department to setup manufacturing and/or purchasing as appropriate.
  • Read and understand technical drawings, procedures, and industry standards.
  • Perform test method validations.
  • Ensures proper test-related documentation is completed, verified and approved.
  • Design and build prototype PCB boards, test fixtures, custom electronics, custom mechanical devices, & custom firmware.
  • Work with other engineers (HW and/or SW) to resolve issues as part of development process.
  • General engineering and manufacturing support.

Requirements:

  • 2 to 5 years of experience in testing electronic boards, finished electronic devices and test equipment
  • Solid knowledge in electronics; analog, power and digital, oscilloscopes, general electronic test equipment
  • Knowledge in C, C++, Java, C#, LabVIEW, MATLAB
  • Working knowledge of Bluetooth Low-Energy, MICS, and other communication protocols used to communicate with active implantable devices
  • 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 60601-1, IEC 60601-1-2, ISO 14708-1 and ISO 14708-3 international standards
  • 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

Embedded Systems Software Engineer

Summary:

The Embedded Systems Software Engineer will be responsible for various engineering functions associated with designing and developing active implantable devices. 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 customers 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 development 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 active implantable 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.
  • 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.
  • Develop embedded software life cycle plan and management for new products.
  • Work with Business Development, Marketing, and customers to identify technology projects.
  • Assist in product development and integrated system testing activities as required.
  • Assist product development in design reviews, and bench testing

Requirements:

  • 2 to 5 years of experience in an embedded systems software development preferably with active implantable medical devices.
  • Experience with Texas Instruments and Zarlink microcontrollers, DSP, SPI
  • Extensive experience programming in C, and C++ for embedded medical device applications
  • Experience using hardware diagnostic instruments to troubleshoot embedded devices
  • Demonstrated experience working with Human Interface Devices (HIDs), developing USB based interfacing software
  • Familiar with IEC 60601 and IEC 62304 international standards
  • 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

Business Analyst

Summary:

Review, analyze and evaluate business systems and user needs. Document requirements, define scope and objectives and formulate systems to parallel overall business strategies.

Responsibilities:

  • Determine operational objectives by studying business functions; gathering information; reviewing customer forecast; reviewing what is loaded into ERP systems; evaluating output requirements and formats
  • Creating a link to customer forecast and business forecast
  • Construct output from customer forecast; business forecast; business dashboards
  • Communicate with customers, sales team, and management on forecasting
  • Construct workflow charts and diagrams; studying system capabilities; writing specifications
  • Improve systems by studying current practices; designing modifications
  • Recommend controls by identifying problems; writing improved procedures
  • Define project requirements by identifying project milestones, phases and elements; forming project team; establishing project budget
  • Monitor project progress by tracking activity; resolving problems; publishing progress reports; recommending actions
  • Maintain user confidence and protect operations by keeping information confidential
  • Prepare technical reports by collecting, analyzing and summarizing information and trends for all sites forecast
  • Contribute to team effort by accomplishing related results as needed
  • Conduct and coordinate financial, product, market, operational and related research to support strategic and business planning within the various departments and programs of the client group
  • Interpret, evaluate and interrelate research data and develop integrated business analyses and projections for incorporation into strategic decision-making
  • Plan and coordinate the development of primary and secondary market research studies in support of strategic planning and specific marketing initiatives, as required and presents findings of studies to client committees
  • Perform daily, weekly and monthly reviews and analyses of current processes using operational metrics and reports
  • Review a variety of areas including operations, purchasing, inventory, distribution and facilities
  • Understand and communicate the financial and operational impact of any changes to forecasting
  • Suggest changes to senior management using analytics to support your recommendations. Actively participate in the implementation of approved changes
  • Create informative, actionable and repeatable reporting that highlights relevant business trends and opportunities for improvement
  • Conduct insightful, ad hoc analyses to investigate ongoing or one-time operational issues

Requirements:

  • Bachelor’s Degree in appropriate field of study or equivalent work experience
  • Microsoft Access and/or SQL experience strongly preferred
  • Ability to impact operations and effect change without being confrontational
  • Detail oriented, analytical and inquisitive
  • Ability to work independently and with others
  • Extremely organized with strong time-management skills
  • Software Design
  • Analysis
  • Teamwork
  • Software Maintenance
  • Process improvement
  • Big Picture Thinking
APPLY NOW  – or email Careers@Cirtecmed.com

Laser Engineer

Summary:

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

Responsibilities:

  • Develop laser welding and cutting process
  • Develop CNC Program and design and tooling
  • Set up and verify quality of production jobs
  • Set up production parameters and insure they are documented and maintained
  • Provide trouble shooting for production jobs
  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to develop laser quotations and manufacturing procedures
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date

Requirements:

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

Facilities Technician - 2nd Shift

Summary:

This position is on 2nd shift and must be able to work 3:00 PM – 11:30 PM, Monday – Friday.

Ensure that all facility systems receive the attention required for Cirtec Medical to run unimpeded. Duties including maintenance schedules are up to date and machines are maintained properly, ensuring Cirtec’s facility is at the highest level of cleanliness and safety. Coordinate through a staff of skilled, semiskilled and unskilled labor, activities concerned with the operation, repair, maintenance, and construction of facilities, equipment, buildings and grounds to minimize interruption and improve efficiency. Carries out facilities systems repairs or may obtain bids for additional work from outside contractors if asked to by management.

Responsibilities:

  • Communicate with team leaders and management about facility needs
  • Safely use chemicals in the cleaning process
  • Maintain an inventory of supplies related to janitorial and facility maintenance
  • Perform plumbing and electrical repairs as needed
  • Provide supervision/leadership to the janitorial/custodial team
  • Perform and/or delegate special projects such as carpet cleaning, wall cleaning, panting, ceiling tile repair, etc.
  • Promote efficiency and cost reduction
  • Provide training for the janitorial/custodial staff
  • Assist in overseeing and directing contracted projects to ensure adherence to specifications
  • Maintain compliance with local, state and federal laws
  • Inspect plant facilities or review inspection reports to determine if repairs are needed, suggest replacement and or improve efficiency
  • Emergency on-call duties as required

Requirements:

  • High school diploma
  • 2+ years of college training in leadership/supervision or equivalent training
  • Effective verbal and written communication and listening skills
  • Ability to represent facilities a tactful manner
  • Proficient with Microsoft Office Suite and email
  • Ability to work with CMMA systems
  • Must be flexible to adapt to changing and varying work requirements
  • Must be able to meet deadlines while the workload level fluctuates
  • Ability to organize and prioritize
  • 8 years facilities experience
  • Ability to use chemicals safely
  • Ability to life 50lbs occasionally
  • Mechanically inclined (able to perform facility and equipment repairs)
  • Ability to use hand tools/power tools
  • Detail oriented and conduct duties and repairs in a cleanly manor
  • HVAC high level systems knowledge
  • Electric mechanical trouble shooting skills
  • Knowledge of cleanroom environments and med device a plus
  • This position is on 2nd shift and must be able to work 3:00 PM – 11:30 PM, Monday – Friday.
APPLY NOW  – or email Careers@Cirtecmed.com

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

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

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

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

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

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

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

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

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

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

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

Quality Control Inspector | 2nd shift

Summary:

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

Responsibilities:

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

Requirements:

Educational:

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

Technical:

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

Competencies:

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

Sales Operations Coordinator | Can be based in CT or MN

Summary:

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

Responsibilities:

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

Requirements/Qualifications:

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

Technician II - 2nd Shift

Summary:

A Technician II has the general responsibility for operating workstations and associated systems used in the manufacturing of products sold to our customers. The Technician II is expected to work with lower level Technicians and other upper level Technicians to effectively meet or exceed expectations for product quality and production rates. In this position they must have a basic knowledge of how to set up and operate workstations, perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Has the primary function of operating workstations used in the manufacturing processes
  • Proficient in set-up and loading component materials into product specific tools
  • Has the responsibility of following established documentation for product manufacturing
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines
  • Accurately documents all work performed on inspection reports and customer travelers
  • Has a general understanding of the CNC controlled workstations on the production floor
  • Possesses the ability to read and follow process control documents, work instructions, and standard operating procedures
  • Working knowledge of drawings, ability to interpret nomenclature and dimensions.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
  • Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers
  • Provides direction within the manufacturing cell to Tech I associates assigned to assist them
  • Performs basic workstation set up and troubleshooting tasks
  • Performs additional duties as required under the direction of the Production Manager
  • Maintains cleanliness of work areas, machines, tools and equipment
  • Assists Quality Control with inspection duties as required
  • Responsible for recognizing quality issues and communicating these issues to quality and/ or Production Supervision
  • Performs other job duties as assigned with minimal supervision
APPLY NOW – or email Careers@Cirtecmed.com

Technician III - 2nd Shift

Summary:

The Laser Technician has the general responsibility for operating laser and associated systems used in the manufacturing of products sold to our customers. The Technician III is expected to work with and assist in the training of lower level technicians to effectively meet or exceed expectations for product quality and production rates. It is also expected that in this position the Technician III will continue to build their skills with the upper level Technicians along with taking tasks and direction from the Engineering departments. In this position you must proficient in setting up and operating workstations perform visual and dimensional inspections needed to manufacture the products at Cirtec.

Responsibilities:

  • Has the primary skills of operating manufacturing workstations including all laser systems used in the manufacture of products sold to our customers. (Unitech, Triumpf, Lasag, IPG)
  • Perform laser welding, resistance welding laser marking, header pouring, silicone molding
  • Glovebox laser welding
  • Strong soldering experience. IPC 610 certification preferred
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines
  • Proficient in the operation of computerized motion controllers
  • Proficient, at an intermediate level, in modifying or creating computerized motion control programs
  • Possesses the ability to accurately follow operating manuals, maintenance instructions, Standard operating procedures & work instructions
  • Working knowledge of drawings with an intermediate ability to interpret nomenclature and dimensions
  • Must accurately document all work performed on inspection reports and travelers
  • Performs in-process inspection of all parts and/or assemblies in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions
  • Performs various dimensional inspection using specific dies or gauges, or dimensional inspection systems, verniers and micrometers.
  • Provides direction within the manufacturing cell to Tech I or II associates assigned to assist them
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities
  • Assist facilities departments and upper level Technicians in duties such as flash lamp or filter changes on lasers
  • Ability to perform workstation set up requirements for any type of processing job using existing tooling and established parameters
  • Performs additional duties as required under the direction of the Production Team Leader or upper level Technicians
  • Responsible for recognizing quality issues and communicating issues to the Qulaity and/ or Production Supervision
  • Assists in ensuring the accuracy of Process Control Documents, Parameter Sheets, Work Instructions, and Standard Operating Procedures
  • Acts as a resource during audits or customer visits for questions and answers or practical demonstrations
  • Assist Upper level Technicians or Engineers with parameter adjustments and weld parameter/process development.
  • Ability to perform metallurgy (cross sections)
  • Performs weld validations and collects data for validation reports
  • Ability to provide input to Engineering and upper level Technicians in regards to tool design and/or troubleshooting processes
  • Performs other job duties as assigned with little or no assistance or supervision

Requirements:

Experience & Education:

  • Be able to read, write and speak fluent English
  • High school diploma or General Education Degree (GED) is required
  • Two to three years experience in a med device field preferred
  • One year applications experience or equivalent training

Technical:

  • Strong experience with a variety of laser welding equipment and techniques
  • Strong soldering skills (IPC 610 certification preferred)
  • Header pouring, laser marking, silicone molding, glove box laser welding
  • Moderate computer skills, including the MS Office suite
  • Must be able to interpret technical drawings, blueprints, specifications & illustrations
  • Strong analytical skills and must have the ability to obtain secondary research information from the Internet or alternate sources
  • Ability to learn and apply new technology
  • Technical report preparation

Physical:

  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds
APPLY NOW – or email Careers@Cirtecmed.com

Opportunities in Los Gatos, CA

Document Control Specialist

Summary:

The Document Control Administrator implements and maintains the Engineering Change Notice System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Provides documentation such as good manufacturing practices (GMP) and good laboratory practices (GLP) procedure manuals and change authorization in accordance with company policies and government regulations.

Responsibilities:

  • Responsible for issuing part numbers and ECN’s and processing documents into the QMS software (i.e. Master Control, Syteline, etc.)
  • Responsible for communicating with customer for obtaining ECN approval.
  • Responsible for compiling and maintaining control records such as release drawings, project documents, quality system documents and manufacturing documents.
  • Responsible for making electronic changes to documents, release documents, and notifies affected departments.
  • Responsible for maintaining related Document Control files.
  • Responsible for ensuring documents are filed correctly and maintained per established procedures.
  • Perform database searches, minor data analysis, and reporting to assist Quality Assurance team.
  • Maintain logs and update CAPA, NCMR, Complaint and other Quality Systems files.
  • Prepare reports and memorandums.
  • Ensure Proper upkeep of quality records and documents.
  • Coordinates Training program, which includes facilitating the training and input results into the training QMS system.
  • Other duties as assigned.

Requirements:

  • Prior experience with PLM software system, such as Master Control is preferred
  • Strong knowledge in implementing, processing, and maintaining Cirtec and Customers documentation in ERP and PLM Software System
  • Extremely detail-oriented work habits
  • 2-3 years experience in the Medical Device Industry required
  • Flexible and motivated attitude
  • Proficient with MS Word, Excel
  • Knowledge of document control procedures with data storage, maintenance, revision and archival background
  • Familiarity with FDA Quality System Regulation (QSR) and ISO 13485
APPLY NOW – or email Careers@Cirtecmed.com

Mechanical Engineering Intern

Summary:

Assists in defining and developing products and processes in both the development and manufacturing environment.

Responsibilities:

  • Develop 3D models and drawings using SolidWorks
  • Work on product design, machine design, and fixture design
  • Able to build, test, and iterate designs in the lab
  • Review and update product requirements, create lab test procedures, collect test data, analyze results and draft engineering reports
  • Perform other R&D and engineering related tasks as assigned

Requirements:

  • Must be a full-time student (Junior, Senior or Graduate) pursuing a degree in Mechanical or Biomedical Engineering with an emphasis in Mechanical Engineering OR a recent graduate
  • Must have a 3.3 cumulative overall GPA or better (on a 4.0 scale)
  • Must have good fundamental understanding of mechanical systems
  • Finite Element Analysis knowledge a plus
  • Labview knowledge is a plus
  • Good communication skills and ability to articulate technical problems
  • Strong Initiative and ability to work independently and in cross-functional teams
  • Legal authorization to work in the U.S.
APPLY NOW – or email Careers@Cirtecmed.com

R&D Engineer

Summary:

The Research & Development Engineer in our Los Gatos, CA office will work in a functional project engineering group consisting of multiple engineering disciplines. The ideal candidate will lead the design, development, documentation and verification of new customer products, and modification of existing products.

Responsibilities:

  • Engage in the full design, development, and validation requirements of projects, including:
    • General manufacturing process development and documentation
    • Clinical and test sample build support
    • Manufacturing transfer
  • Lead, attend and schedule project meetings to discuss current and future design and development initiatives as necessary.
  • Serve as a primary contact/technical lead with clients on projects of low to moderate complexity.
  • Assist in preparing proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintenance of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions.
  • Provide consistent input to project manager regarding project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs/outputs:
    • Feasibility and initial planning documents and hazard analysis.
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
    • Materials sourcing and device prototyping.
  • Evaluate and select appropriate test methods for product requirements.
  • Feasibility builds, testing, and documentation.
  • Design and application failure mode analysis.
  • Design Verification testing.
  • Other duties as assigned.

Requirements:

  • Must maintain high ethical standards
  • Must demonstrate good organizational skills
  • 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
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics
  • Ability to train new engineering employees Cirtec policies and procedures
  • Must be able to read, write and speak fluent English
  • Bachelor’s degree in an engineering discipline with 1-3 years relevant experience
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

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.
  • Improve 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.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur. Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Other duties as assigned.

Requirements:

Educational:

  • Bachelor’s degree in Engineering or related field
  • Excellent verbal and written communication skills
  • Fluency in English
  • Knowledge of manufacturing and assembly processes

Technical:

  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • 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.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.
  • An awareness of health and safety issues.
  • Willingness to travel, if required.
APPLY NOW – or email Careers@Cirtecmed.com

General 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