Careers with Cirtec – Medical Device Design, Manufacturing, and Finished Device Assembly

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

Press Room Setup/Operator

Responsibilities:

  • Perform a variety of moderate stamping, drawing and forming operations, which includes the use of compound, combination and some progressive dies
  • Run all types of equipment safely and smoothly, report when rates aren’t achievable and may be part of implementing changes in order to achieve quoted rates
  • Promptly watch, listen and recognize any changes or faulty operations in any process that they have been trained on
  • Responsible for the quality of the parts they produce and following manufacturing inspection plans
  • Record statistical process controls and run any type of inspection equipment they have been trained on
  • Able to load coils
  • Follows detailed work instructions, both verbal and written (traveler and any other)
  • Package parts
  • Maintain a clean, organized and safe work environment
  • Perform machine maintenance, preventative maintenance and safety checks as required
  • Read blueprints and understand basic geometric tolerances
  • Pro-actively pursue continuing education and personal development opportunities in area of expertise
  • Follow all company and ISO procedures, maintain procedures as assigned and actively participate in continuous improvement initiatives
  • Promote a safe and positive work environment
  • Support activities required to implement and maintain the company’s strategic and departmental objectives
  • Keep abreast of latest in technology regarding area of expertise. Make recommendations to implement where feasible
  • Effectively communicate with other departments, supervisors and managers, including participation in meetings as required
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

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

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Mechanical Designer

Responsibilities:

  • Generate 3D models and Engineering drawings
  • Design detailed tooling, gage, and fixture engineering drawings independently and with input from the subject matter expert or engineer
  • Review engineering drawings to ensure adherence to specifications and standards
  • Design reviews
  • Manage workload to support various departments
  • Work effectively with other departments to resolve drawing discrepancies
  • Work with product development teams to ensure compliance when transferring documents to production releases
  • Maintain strict adherence for multiple CAD file relationships, models, assemblies, libraries and symbols
  • Maintain compliance to procedures and regulatory requirements
  • Maintain CAD database support in multi-user environment
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 10 Plus years’ experience in the engineering/manufacturing environment (Machining, Finishing, and assembly) for medical devices related to product and tool design
  • 3D Printing knowledge
  • Understanding of mold design
  • Understanding of toolmaking/machining practices.
  • Solid working knowledge of dimensioning and Geometric tolerances, GD&T
  • Computer skills associated with Microsoft software
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Possess team collaboration skills
  • Must be able to make clear and accurate decisions
  • Strong mechanical aptitude
  • Possess degree of professionalism
  • PLM/PDM file management experience preferred
  • Associates degree in an Engineering discipline or related field

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office/manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Facilities Manager

Summary:

This position is primarily responsible for the day-to-day implementation of policies, procedures, and programs that will assure a well-maintained facility. Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that coordinates the activities, suppliers, and manpower required for current and future needs of the facility within constraints of time, quality and cost.

Responsibilities:

  • Design, plan and manage all aspects of the facilities function for the facility, which may include but is not limited to maintenance, equipment, machinery, construction, building space allocation and layout, office services, leased properties and furnishings, and building security
  • Plan, budget and schedule facility modifications and moves, including cost estimates, bid sheets, layouts, buildouts, and contracts for construction and acquisition
  • Ensure all interior space requirements, building layout/footprints, architectural elements, corporate environments demands, aesthetics, department work requirements and HVAC (Heating, Ventilating, Air Conditioning) needs are consistently met and maximized
  • Participate in negotiation of service contracts with outside suppliers
  • Ensure projects are completed within time and budget specifications
  • Maintain knowledge of current and emerging trends in technologies, techniques and approaches in space planning and allocation, and space optimization methodology
  • Enforce safety, security, and emergency guidelines
  • Ensure that facility maintenance requirements are consistently met
  • Promptly respond to facilities related issues and ensure effective resolution
  • Keep apprised of current regulations in order to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Minimum 5 years’ experience in facilities management to include the following: design, construction, build out, interiors, branding, space planning, maintenance and custodial development
  • Extensive experience with supplier negotiations and supplier management
  • Strong project management skills and an ability to oversee multiple projects simultaneously
  • Excellent communication skills and leadership skills with the ability to influence multiple business partners across all levels
  • High level of customer service aptitude
  • Proven track record of resolving complex business issues and making sound decisions
  • Prior experience in complying with OSHA and ADA regulations
  • Knowledgeable in establishing and enforcing safety, emergency and security procedures
  • Experience with sustainable design or energy use reduction methods

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT

Work is performed in both an office and manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

NPI Buyer

Responsibilities:

  • Vendor selection, qualification and development.
  • Develop strong relationships with vendors to ensure quality and delivery at best in class costs.
  • Establish and improve purchasing and planning parameters (lead times, MOQ’s, tiers and pricing).
  • Ensure vendor performance supports design requirements and production goals.
  • Review MRP to verify accurate demands and to place orders for inventory components on a timely basis.
  • Transition production ready vendors and or components or services to sustaining buyers.
  • Support project and program teams as key sourcing resource.
  • Work with Engineering and review new item masters to ensure item masters are set up correctly to maintain proper finance, inventory and purchasing guidelines.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Demonstrated supply chain creation, management and improvement experience.
  • A record of creating and improving vendor relationships.
  • Ability to read and interpret technical specifications, prints and requirements.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with demonstrated progressive sourcing experience.
  • Bachelor’s degree preferred.
  • Working knowledge and experience in Lean and Six Sigma methods, ERP and QMS systems, and logistics and procurement processes.
  • Experience with ISO 9001 and ISO 13485 procedures preferred.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Project Manager - Supply Chain

Responsibilities:

  • Project Management with a focus on supply chain creation for strategic programs.
  • Create resilient and scalable supply chains to ensure quality and delivery at best in class costs.
  • Integrate supply chains into execution teams with seamless handoffs.
  • Serve as core team member for strategic programs.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Demonstrated supply chain management and improvement experience.
  • A record of creating and improving supply chains.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with project and or program management experience.
  • Bachelor’s degree preferred.
  • Working knowledge and experience in Lean and Six Sigma methods, ERP and QMS systems, and logistics and procurement processes.
  • Experience with and managing with ISO 9001 and ISO 13485 procedures preferred.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Principal Mechanical Design Engineer (IPG)

Summary:

Defines, develops and designs implantable pulse generators (IPGs) and other Class II and III active implantable devices. Owns efforts in developing solutions to product design, and design for manufacturability. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs. Effectively communicate to all levels of the organization.

Responsibilities:

  • Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
  • Utilize design, analysis, and statistical tools, including SolidWorks, Minitab, DOE, Measurement System Analysis, 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.
  • Leading and/or participating in DFMEA, PFMEA, and risk analysis activities.
  • Performs design reviews and pre-verification assessments to ensure design outputs will be met.
  • Writes/updates part specifications, mechanical drawings, and various technical documents.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • 5-7 years of experience in the medical device industry with responsibility for designs, materials, and processes for 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 tolerance analysis.
  • A BS degree in relevant engineering discipline.

Desired Requirements:

  • Experience designing Implantable Pulse Generators or similar devices.
  • Understanding of standards and requirements related to Implantable Pulse Generators or similar devices
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Mechanical Design Engineer

Summary:

Defines, develops and designs medical devices and related accessories. Owns efforts in developing solutions to product design, and design for manufacturability. 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.
  • Utilize design development, analysis and statistical tools, including SolidWorks, Minitab, DOE, Measurement System Analysis, 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.
  • Leading and/or participating in DFMEA, PFMEA, and Risk analysis activities.
  • Performs design reviews and pre-verification assessments to ensure design outputs will be met.
  • Writes/updates part specifications, mechanical drawings, and various technical documents.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • 3-5 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 tolerance analysis
  • A BS degree in relevant engineering discipline
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Process Development Engineer (Nitinol)

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Focusing on manufacturing with Nitinol, design of Nitinol components and adjacent tooling, this role is also involved in the documentation and validation 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:

  • Production lead for driving eligible processes through the transfer from development to production.
  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project deliverables:
    • 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

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

Nitinol manufacturing and/or design experience.

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 5 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 7 years appropriate work experience; or a minimum 10 years relevant work experience; or equivalent.
  • 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.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Cost Accountant

Summary:

The Cost Accountant works closely with the Operations Controller as the subject matter expert on all cost accounting activities for the company, ensuring an accurate representation of product and manufacturing costs and expenses on the company’s financial statements.

Responsibilities:

  • Identify, analyze, and report variances in product costing, job costing and production activities. Review labor and overhead application and variances.
  • Collaborate with manufacturing, supply chain, and quality leaders with efforts to reduce costs, variances, customer returns, and manufacturing scrap.
  • Establish and execute cost controls for item masters, bills of materials, work centers, and job travelers.
  • Assist our sales engineers in producing customer quotes to ensure all costs are captured and appropriate profit margins are maintained.
  • Perform monthly account reconciliations, analysis, and reporting for inventory, WIP, and variances. Also provide gross margin analysis per product line and customer.
  • Provide support for year-end and other 3rd party audits of our inventory. This will include the identification of slow-moving and obsolete inventory and communicate recommendations for the valuation and disposition of these items.
  • Assist with the budgeting process for cost and product related valuations and estimates. Provide explanations of variances and deviations of the current budget to the actual results.
  • Support IT initiatives with system improvements, upgrades and/or conversions. Act as accounting representation in cross-functional teams to properly develop and execute cost and manufacturing transaction procedures to maximize the efficiency and use of our resources.
  • Assist with capital expenditure requests by providing return on investment analysis as needed.
  • Perform other related duties as assigned by management.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Bachelor’s degree in accounting or related field
  • Excellent analytical and communication skills
  • High level skills with ERP systems
  • Proficient use of Word, Excel, and Outlook
  • Must be self-motivated, and the ability to work independently with minimum supervision

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Applications Engineer

Summary:

The Senior Applications Engineer will serve as principal technical contact with external customers during the business development process and will be mainly responsible for defining scope, timeline, and budget for new medical device development programs / projects.

Responsibilities:

  • Serves as the principal technical contact with external customers during the business development process and participates actively with business development team to engage new customers to specify project / product requirements and effectively communicate Cirtec’s capabilities to customers
  • Leads definition of scope, timeline, and budget for new development programs and prepares budgetary project plans, development proposals and quotations for new and existing customers
  • Collaborates with the engineering teams to coordinate integration of existing individual processes and platform capabilities to facilitate product development process
  • Understands and communicates emerging technologies, market trends, customer strategies, competitive intelligence and overall market landscape to internal stakeholders to improve company’s development and manufacturing capabilities
  • Supports program management team during program kick-off and planning phases, and assists them in preparing change orders and new quotations during development phases
  • Participates in continuous improvement of company’s design control procedures and internal business processes based on emerging industry trends
  • Communicates with strategic vendors and suppliers, and builds strong business relationships
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • BS in Biomedical / Mechanical / Electronics / Computer engineering discipline with at least 10 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies highly preferred.
  • Must have experience working on medical device development projects from early stage design through verification/validation, and transfer to production
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Must have proficiency in MS Office software
  • Must possess excellent written and oral communication skills in English
  • Willingness to travel, if required

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Facilities Coordinator

Summary:

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:

  • Manage required facility and custodial documents per Cirtec’s policy
  • Perform and/or delegate janitorial duties to ensure the highest level of safety and cleanliness at Cirtec Medical
  • Safely use chemicals in the cleaning process
  • Maintain an inventory of supplies related to janitorial and facility maintenance
  • Perform plumbing and electrical repairs ae 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.
  • Assist in overseeing and directing contracted projects to ensure adherence to specifications
  • Promote efficiency and cost reduction
  • Provide training for the janitorial/custodial staff
  • Oversee and direct contracted projects to ensure adherence to specifications
  • Maintain compliance with local, state and federal laws
  • Inspect plant facilities or review inspection reports to determine repairs, replacement and or improvements required
  • Maintain environmental records and waste reports as required
  • Inspect chemicals and ship wastes as needed
  • Create purchase requests for needed repairs and inventory
  • Be an active part of the safety team
  • Participate in Safety Committee meetings
  • Provide safety training as needed
  • Attend trainings as needed
  • Emergency on-call duties as required
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • High school diploma-GED
  • Must be able to meet deadlines while the workload level fluctuates
  • Ability to life 50lbs occasionally
  • Basic computer skills
  • Effective verbal and written communication and listening skills
  • Ability to represent facilities a tactful manner
  • 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
  • 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 safely and efficiently
  • Detail oriented and conduct duties and repairs in a cleanly manor
  • Electric mechanical troubleshooting skills
  • Knowledge of cleanroom environments and med device a plus

Preferred:

  • 2+ years of college training in leadership/supervision or equivalent training
  • Proficient with Microsoft Office Suite and email
  • 4 years facilities experience
  • HVAC high level systems knowledge

PHYSICAL DEMANDS: While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Engineer Technician

Summary:

Cirtec Medical is searching for an Engineering Technician to join its Operations team. In the fast-paced medical contract manufacturing space, this position is primarily responsible to support engineering and production. Our Engineering Technicians assist Manufacturing Engineers to document processes, update documentation, implement creative ideas or solutions to improve assembly operations, and develop tooling/fixturing as needed.

Responsibilities:

  • Actively participate in improving quality and processes for the products we manufacture
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements
  • Assist in training employees on equipment and assembly skills
  • Interact effectively and assist engineering in improving quality and solving problems
  • Show self-motivation to optimize job performance on a continual basis
  • Maintain a clean and orderly work area
  • Ability to diagnose and solve problems with jobs in a timely manner
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • 3+ years’ experience in the engineering / manufacturing environment of medical device component assembly
  • Excellent working knowledge of technical drawings, blueprints, specifications, illustrations and geometric tolerances
  • Strong problem solving and process validation experience is a plus
  • Strong computer skills including MS Office, Project, Document Control systems, Adobe Acrobat
  • Must be able to read, write and speak fluent English
  • Possess good reading, writing, communication, and organizational skills
  • Maintain performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Strong desire to learn and apply new technology

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

Work is performed in an office and manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Program Manager

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

The Senior Program Manager will be mainly responsible for managing and coordinating design and development of novel medical devices.

Responsibilities:

  • Manages and coordinates design and development of complex and novel Class II & Class III mechanical and electro-mechanical medical devices such as active implants and peripherals, surgical devices and external devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Supports project team in establishing and maintaining product requirements and test plans
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers
  • Mentors and provides guidance to other program manager(s) and engineers
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • BS in a relevant engineering or science discipline with at least 10 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies preferred but not required.
  • Minimum 5 years of experience in project / program management of medical device development programs
  • Demonstrated ability to lead medical device development projects from early stage design through verification/validation, and transfer to production
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required

PHYSICAL DEMANDS: While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Program Manager

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

The Program Manager will be mainly responsible for managing and coordinating design and development of novel medical devices.

Responsibilities:

  • Manages and coordinates design and development of complex and novel Class II & Class III mechanical and electro-mechanical medical devices such as active implants and peripherals, surgical devices and external devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Supports project team in establishing and maintaining product requirements and test plans
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • BS in a relevant engineering or science discipline with at least 5 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies preferred but not required.
  • Demonstrated ability to lead medical device development projects from early stage design through verification/validation, and transfer to production
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required

PHYSICAL DEMANDS: While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. 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 as well as continuation design & development support for sustaining manufacturing and product distribution. 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 2-5 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 CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

The position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • Design Input/ Output Characterization & Specification
  • Manufacturing Process Verification & validation Controls
  • Gage R&R, Test/Inspection Method Development & Qual.
  • Statistical Qualitative and Quantitative Data Analysis
  • Complaints Investigation/Returned Materials Analysis
  • Manufacturing Engineering support
  • Education & Training
  • ISO Class Controlled Environments
  • Metrology & Calibration (including Gage R&R)
  • Tracking and Trending Quality Objectives and Metrics,
  • Other Quality Management System Functions

This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Requirements:

Educational: 

  • Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferable industry work experience (Engineering or Quality discipline preferred).

Technical: 

  • Minimum of 2-5 years of experience in a regulated manufacturing environment.
  • 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 CareersAtCirtec@Cirtecmed.com

Quality Control Inspector

Summary:

This position is primarily responsible for performing 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 non-conforming 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.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance
  • 3 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

PHYSICAL DEMANDS  While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Laser Technician

Summary:

This position is responsible for the safe and functional operation of laser cutting and welding equipment.  Will be responsible for developing manual or CAD programs required to cut or weld components.  Will assist in the development of tooling and fixtures required. To be self-motivated. Help lead the team in a manner to maximize production, Quality, and day-to-day functions.

Responsibilities:

  • 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 Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • 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
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seek assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner

Qualifications:

  • Recent pulsed laser cutting experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Software (Embedded) Engineer

Summary:

Based out of our headquarters in Brooklyn Park, MN, The Sr. Software (Embedded) Engineer will be mainly responsible for development and integration of embedded software for novel Class II and III medical devices.

Responsibilities:

  • Participate in software system architecture development and document software requirements and development plan
  • Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements
  • Track software related issues and lead resolution of issues with a well-documented and methodical approach
  • Develop software test and verification plans and protocols, and conduct prototype testing and verification testing
  • Work closely with hardware engineering team to debug/integrate software with hardware
  • Collaborate with program managers to create and manage development plans and project plans related to software development
  • Lead and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
  • Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files

Requirements:

  • Experience with microcontrollers (ARM, Texas Instruments), communication controllers (Zarlink, Bluetooth), IC interfaces (SPI,I2C), DSP
  • Extensive experience developing firmware solutions using C, C++, and Assembly (experience with event driven and state machines designs preferred)
  • Strong HW / SW bring-up and debugging skills
  • Capable of working independently in a hardware lab with oscilloscopes, signal generators, power supplies and other test equipment
  • Knowledge and understanding of IEC 60601 and IEC 62304 and other relevant medical device regulatory standards highly preferred but not mandatory
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Systems Engineer

Summary:

Based out of our headquarters in Brooklyn Park, MN, the Sr. Systems Engineer will be mainly responsible for system-level development and implementation of electronic and software designs for novel Class II and III medical devices.

Responsibilities:

  • Lead system architecture design, sub-system requirements partitioning, requirements management and configuration management during product development
  • Develop system requirements, technical specifications and development plans based on marketing and regulatory needs, and applicable standards
  • Ensure that all hardware and software requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability and serviceability within the constraints of the project schedule and budget
  • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams
  • Manage and lead resolution of systems engineering issues including systems architecture, hardware and software design trade-offs
  • Develop verification and test plans and protocols, and manage prototype testing and design verification testing
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development
  • Lead and contribute in creation of risk management documentation, including Failure Mode Effects Analysis
  • Develop and maintain documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files
  • Manage and assist in creation of manufacturing process instructions, bills of material, quality inspection, and related documentation

Requirements:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • Experience with development of neuromodulation devices highly preferred.
  • Demonstrated expertise in systems engineering and requirements management
  • Working knowledge of medical device regulatory standards, for e.g. IEC 60601 and related standards
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Process Engineer - Manufacturing

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
  • 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 CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

Systems Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

Based out of our division in Chandler, AZ, the Systems Engineer will be mainly responsible for system-level development and implementation of electronics and software designs for novel Class II and III medical devices.

Responsibilities:

  • Develop verification and test plans and protocols, and manage prototype testing and design verification testing
  • Develop calibration processes, for medical device RF communication systems such as the Microsemi ZL70103
  • Facilitates and coordinates development and implementation of electronic and software system designs with cross-functional engineering teams
  • Facilitates system architecture design, sub-system requirements partitioning, requirements management and configuration management during product development
  • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development
  • Develop and maintain documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files
  • Manage and assist in creation of manufacturing process instructions, bills of material, quality inspection, and related documentation

Requirements:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • 5+ years’ experience as systems engineer or test engineer.
  • 2+ years working on medical device development
  • Experience with development of neuromodulation devices highly preferred.
  • Experience with the Microsemi ZL70103, TI MSP430, Arm Cortex M4 and/or TI MSP430 highly preferred
  • Demonstrated expertise in systems engineering and requirements management
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 50 pounds while moving equipment.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in a lab and/or office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Enfield, CT

Manufacturing Engineer-Laser Weld

Summary:

This position is responsible for developing laser and resistance welding techniques, procedures, and application of welding equipment to problems involving fabrication of metals, utilizing knowledge of production specifications, properties and characteristics of metals and metal alloys, and engineering principles.

Responsibilities:

  • Develops welding techniques, procedures, and application of welding equipment to problems involving fabrication of metals, utilizing knowledge of production specifications, properties and characteristics of metals metal alloys, and engineering principles.
  • Conducts research and development investigations to develop & test new fabrication processes and procedures, improve existing or develop new welding equipment, develop new or modify current welding methods, techniques and procedures,
  • Prepares technical reports ((OQ) as result of research & development preventive maintenance investigations.
  • Establishes welding procedures, setup instructions, to guide production and welding personnel relating to specification restrictions, material processes, and establishes the essential variables related to maintaining a robust process that assures process stability.
  • Evaluates new technology as it pertains to welding and its possible application to current welding problems or production processes.
  • Directs coordinates technical personnel in performing inspections to make sure workers compliance with established welding procedures, restrictions, and standards; in testing welds for conformance with national code requirements; or testing welding personnel for certification.
  • Contacts personnel of other agencies, engineering personnel, or clients to exchange ideas, information, or offer technical advice concerning welding matters.
  • May perform experimental welding to evaluate new equipment, techniques, and materials.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Understanding of AWS CWI required
  • Bachelor’s degree in Mechanical, Manufacturing or Metallurgical Engineering required an associate degree in Weld Engineering is acceptable w/5+years’ experience
  • 5+ years of weld experience required
  • Strong mechanical background relating to welding and assembly
  • CNC programming of automated welding equipment preferred
  • Dry Box experience preferred
  • Knowledge of welding equipment, measuring instruments, and electric and pneumatic eq.)
  • Certification from an accredited school in laser or resistance welding technology
  • Certification in Laser Safety
  • Ability to read, analyze and interpret drawings, standards, welding codes and other technical documents
  • Ability to effectively communicate information to internal/external customers

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Site Quality Manager

Summary:

This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned Cirtec Medical Facility.

Responsibilities:

  • This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • Designated Site-level Management Representative for assurance of compliance to the Cirtec Medical Quality Management System and member of the Site-Senior Management Team for the facility.
  • Drive and Support Corporate QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.).
  • Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, development programs and manufacturing customers.
  • Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
  • Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
  • Provide Leadership and Guidance for site-level Design and Development programs, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Hazard Analysis and Assessment – Design & Process), Design and Limit Characterization, and Process Qualification (DV&V and PV).
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as Cirtec Medical policies.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

This position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
  • Author and execute Quality Plans for Quality Product Design and Development projects.
  • Initiate and/or consult in the development and/or update of Risk Management 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.
  • 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.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s.
  • Provide statistical data / trending analysis on CAPA, Complaint, NCMR and other quality metrics.
  • Support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees.
  • Responsible to ensure these actions are performed in compliance with Federal, local and organizational laws/policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 2-5 years’ experience in a regulated manufacturing environment. Preferred Qualifications & Experience:
  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience. • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in effectively supporting audits by customers and external regulatory agencies.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Program Manager

Summary:

This position is primarily responsible for executing the project plan and managing the project initiative to established budget and timeline. Coordinate the design, development, documentation, and validation of complex new and modified customer products.

Responsibilities:

  • Organize a project plan for complex projects to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets internally and externally. Serve as principal contact with clients. Coordinate and direct site visits, conference calls, and day-to-day customer communication.
  • Coordinate 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 monitor the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommend and implement corrective actions.
  • Oversee the process of preparing new or modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Author planning documents as required to support assigned projects.
  • Contribute to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assist business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manage resources assigned to the project team to meet project goals/milestones. Work with management to ensure project has proper resources assigned.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Willingness to travel, if required.
  • Required to maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline with 5 years of applicable experience or equivalent.
  • Minimum 3 years in project engineering. Demonstrated ability to lead projects from early stage development to production.
  • Minimum 7 years’ experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information. • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Systems Engineer

Summary:

The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Responsibilities:

  • Corrective/Preventative Actions (CAPA):
    • Serves as Subject Matter Expert (SME) for the CAPA system.
    • Responsible for CAPA system administration, including conducting periodic meetings, tracking individual CAPAs, and, as necessary, performing work on individual CAPAs.
  • Complaints Investigation/Returned Materials Analysis:
    • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Nonconforming Material (NCM) Control:
    • Knowledge of ID, traceability, and containment requirements for handling of NCM.
    • Knowledge of Material Review Board (MRB) responsibilities and handling of NCM.
  • Supplier Quality Management:
    • Support supplier/vendor Qualification activities.
    • Support Management of the Approved Supplier/Vendor Listing (ASL/AVL).
    • Manage Supplier/vendor Corrective Actions (SCAR).
  • Internal Auditing:
    • Provide Support for the system to ensure all internal audits are performed as scheduled.
    • Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations/findings and reporting.
  • Documentation Control:
    • Support local Document Control (PLM) and Material Resource Planning (MRP) systems.
  • Training and Education:
    • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Preventive Maintenance, Calibration & Metrology (Gage R&R):
    • Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment.
  • Author and execute Quality Plans for the QMS and Organizational Objectives projects.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Provide support for the compliance of Quality System support elements (QM ‘feeder’ systems) for the site QMS and the tracking & reporting of associated metrics, as required.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Provide quality support on maintaining ISO Class clean rooms including review and trending of the testing and monitoring reports
  • Support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 2-5 years’ experience in a regulated manufacturing environment.
  • Technical training and/or experience in a related field.
  • Must be able to read, write and speak fluent English.
  • Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820 (FDA cGMP/QSR).
  • Familiarity with Class II or Class III medical devices
  • Experience in use of computer systems specifically Microsoft Office, calibration and maintenance programs.
  • Strong verbal and written communication skills
  • Ability to work with a wide variety of functional areas, including but not limited to Program Management, R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Must be able to respond to changing priorities with minimum disruption.
  • Must possess organizational skills.
  • Ability to troubleshoot problems in a narrow time frame.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector-2nd shift

Summary:

This position is primarily responsible for performing 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 non-conforming 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.
  • Other duties as assigned.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma-GED.
  • Certificate/s of training related to this field of work (medical or quality assurance.
  • A minimum of 2 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Sr. Electrical Engineer

Summary:

The Senior Electrical Engineer will be mainly responsible for design and development of electronic systems as part of novel Class II and III medical devices.

Responsibilities:

  • Develop and implement circuit designs, including circuits for analog input signal conditioning, embedded control, telemetry, inductive power coupling, power supplies, battery systems, power management and battery charging
  • Develop electronic system and sub-system requirements, and development plans
  • Perform detailed design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Design and/or lead design of printed circuit assemblies and electromechanical assemblies, including prototype development, testing and troubleshooting
  • Collaborate with software engineering team to specify, test and verify embedded software and firmware in the system
  • Interface with and manage suppliers to fabricate prototype and final design components
  • Participate in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Build, test, debug, and maintain configuration of prototype assemblies
  • Develop test plans and protocols, and execute prototype testing and formal design verification testing
  • Perform Failure Mode Effects Analysis and participate in creation of risk management documentation
  • Develop and maintain documentation for specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Create and release medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Participate in the development of quality inspection and manufacturing process instructions for electronic assemblies

Qualifications:

  • BS in Electronics / Computer Engineering or in an equivalent engineering discipline
  • 10+ years of experience within the medical device industry or a highly regulated industry
  • Expert level skills in electronic circuit design and commercial product design experience in areas of Neuromodulation, Embedded Control Design, Battery System and Power Management Circuits, Real-time Signal Processing, Wireless Charging and Communication highly preferred.
  • Expertise in electronic design automation tools: e.g.: PCB design (Altium preferred), schematic capture, analog and digital circuit simulation, tolerance analysis.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineering Manager

Summary:

Based out of our facility in Los Gatos, CA, the Manufacturing Engineering Manager will be mainly responsible for managing and supporting sustained production, and launch of new products into clinical and/or pilot production.

Responsibilities:

  • Develops and implements robust cost-effective manufacturing processes and improves product flow, assembly methods, and product quality and safety performance for both sustained and new products
  • Coordinates the design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
  • Provides support and supervision to direct reports for the timely completion of projects, improvement initiatives and key activities
  • Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
  • Develops manufacturing process instructions, inspection plans and lot history travelers
  • Develops and maintains process risk management documentation (PFMEA) to identify potential risks, and implement preventive and corrective actions
  • Manages and/or supports equipment management, qualification and calibration
  • Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations
  • Collaborates with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM)
  • Performs analysis for cost reduction, and quality and efficiency improvement
  • Prepares engineering change orders and coordinates the implementation of changes including training production staff
  • Troubleshoots designs and processes when defects occur, and determines root cause and implements effective containment and countermeasures
  • Dispositions non-conforming products and develops required re-work procedures
  • Serve as Project Lead / Manager for sustained production projects and prepare periodic status reports for sustained production projects
  • Communicates with customers regarding process improvements and production changes
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Mechanical / Industrial Engineering or in an equivalent engineering discipline
  • 10+ years of experience in manufacturing/process development, with 5+ years of technical staff management experience preferred
  • 5+ years of experience in medical device manufacturing
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies
  • Solid knowledge of GMP and ISO regulations
  • Demonstrated success in leading and managing people in a team-based environment
  • Must be proficient in Solidworks and must be able to interpret technical drawings and specifications
  • Strong computer skills, including the MS Office suite
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Must have demonstrated organizational skills to manage multiple priorities and schedules
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Continuous Improvement Engineer

Summary:

This position is primarily responsible for identifying and leading execution of a wide range of Continuous Improvement projects using industry best practices in Lean and Six Sigma approaches. Leads, facilitates, executes, and manages projects to reduce waste and variation through use of Lean and Six Sigma tools and methodologies. Utilize his/her knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project execution to identify, prioritize and recommend improvement projects that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals and standardization and implementation of initiatives intended to improve quality, cost and delivery
  • Supports productivity, quality, process efficiency, space utilization, and standardization and lead time improvement efforts for existing and new product development programs
  • Supports the philosophy of the Toyota Production System through leading standardized use of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, value stream mapping, time studies, line balancing efforts, setup time reductions, process layout and flow improvement, 5S and standard work
  • Collaborates with cross functional teams as required
  • Evaluates, designs and implements new layouts: including storage rack, conveyor, automation, and other material handling solutions for facilities
  • Leads facility kaizen and productivity projects; ensuring projects are done according to budget and timeline
  • Serves as a statistical resource to a manufacturing/research facility requires a mastery of basic to advanced statistical techniques
  • Seeks out continuous improvement opportunities, weights their value based on benefit, investment and risk, and prioritizes work, accordingly
  • Participates in project work to help customers and operators achieve sustainable results
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS degree, preferably in Industrial Engineering or related field or equivalent experience; advanced degree a plus
  • 3 to 7 years’ in manufacturing experience; preferably in medical device; preferably in machining and assembly of implantables
  • Six Sigma or Lean Certification (ASQ or IASSC) preferred
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team settings
  • Be adaptable to accept new changes in the field of lean manufacturing and should remain abreast with the latest developments happening in that field
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to influence and engage others to accomplish projects
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization
  • Strong organizational abilities; multitasks, prioritizes and meets deadlines in timely manner
  • Ability to travel to sister sites (approximately 5-10%)

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Site Quality Manager

Summary:

This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned Cirtec Medical Facility.

Responsibilities:

  • This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • Designated Site-level Management Representative for assurance of compliance to the Cirtec Medical Quality Management System and member of the Site-Senior Management Team for the facility.
  • Drive and Support Corporate QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485).
  • Provide organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, development programs and manufacturing customers.
  • Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
  • Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
  • Provide Leadership and Guidance for site-level Sustained Manufacturing Programs and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Hazard Analysis and Assessment – Design & Process), Design and Limit Characterization, and Process Qualification (DV&V and PV).
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as Cirtec Medical policies.
  • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor-Weekend 2nd Shift

Summary:

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Responsible for ensuring conformance to all company policies, procedures and work instructions.
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conduct daily team meetings for proper communication and development of production team.
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs. Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics.
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization.
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the preventative maintenance program.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • Associates degree or equivalent experience in a related field
  • Computer literate (MS Office Suite, Syteline) • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities. • Must be able to read blue prints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.
APPLY NOW – or email CareersAtCirtec@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 CareersAtCirtec@Cirtecmed.com