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

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 medical devices, that include Class II and III.  The System Engineer will work on systems integration of hard and software of multiple medical device projects and customers. This individual will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

• Create requirements, engineering specifications, tests during the life cycle of the product development.
• Knowledgably of applicable medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485.
• 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.
• 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.
• Create, review test software requirements, architecture, develop and executing the test code.
• Knowledge of Quality Management System principles and methodology.
• JAMA Product Development Documentation Management a plus.
• Participate in product development meetings and software/hardware design and risk analysis reviews.
• Specify and assemble hardware for tests.
• Maintain design history file and participate in periodic phase reviews.
• Create reports to the stakeholders and create test logs.
• Provide inputs to the team in order to improve the medical device design and test outcomes.
• Use a thorough, systematic, open approach to problem-solving.
• 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 Electronics or Computer Engineering or in an equivalent engineering discipline.
• Advanced degrees preferred.
• Minimum of 5 years’ experience in active and passive implantable devices, peripherals for medical devices.
• Class III medical device experiences preferred.
• Meticulous attention to detail, including ability to maintain accurate records and traceability.
• Experienced in electronics; analog, power and digital, oscilloscopes, general electronic test equipment.
• Experienced of Quality Control principles and methodology.
• Good Communication and interpersonal skills.
• Analytical reasoning and problem solving.
• Experience in developing requirements, engineering specifications, procedures.
• Team player and goal oriented.
• Agile, Scrum, knowledge.
• Excellent oral, written, and presentation communication skills.

Summary:

This position is primarily responsible for producing the highest quality tool’s in our medical manufacturing facility.

Responsibilities:

• Set-up and Operate CNC tool grinding machines, using blueprints, job orders, and knowledge of abrasives and metal properties.
• Program CNC tool grinding machines.
• Clean and conduct general maintenance to department machines.
• Select ,True and Dress Diamond wheels.
• Create close tolerance, carbide micro tooling, from solid blanks.

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 4 years, Set-up 6 axis tool and cutter grinders with pallets.
• Programming with conversational and M&G formats.
• Familiar with Rollomatic and TTB machines.
• Quick turn Manual grinding.
• Knowledge of Manual and Automatic wheel dressing.
• Knowledge of balancing wheel packs.
• Inspection with usage of microscope, shadow, vision systems, micrometers.
• Must be able to read, write and speak fluent English.
• Must be able to convert inch to metric.

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 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.

Summary:

Ensure that all facility systems operate optimally to mitigate negative impacts to customer service, quality operations, engineering and any/all other Cirtec BP internal customers. Primary responsibilities include monitoring, maintaining, operating and general oversight of facility systems, equipment, building and grounds.  Provide general facility services to internal customers to ensure optimal customer service. Assist with projects as assigned regarding design, planning, installation, operations, removal, commissioning, qualifications, and documentation.  Assist with developing, refining, and updating preventative and predictive maintenance procedures and documentation. Work directly with contracted services as assigned.

Responsibilities:

• Perform routine facility work tasks as required to meet internal customer service needs.
• Collaborate consistently and effectively with EHS to ensure a safe and clean working environment.
• Perform assembly, installation, removal, testing, calibration, and maintenance of facility equipment and systems.
• Assist with facility project planning, definition, implementation, execution, and completion of tasks.
• Document, analyze and communicate work performed, actions, irregularities, and continuous improvement needs.
• As needed, act as point of contact for outside contractors regarding facility equipment or systems scheduling, planning and work.
• Assist with developing, documenting, deploying, and sustaining the predictive and preventive facilities maintenance program.
• Assist with maintaining equipment parts and supplies inventories.
• Provide professional communications to internal customers, contractors, suppliers, and vendors.
• Ability to promote the company’s goals of quality, customer service and continuous improvement through employee engagement.

Requirements:

To perform this job successfully, an individual must be able to satisfactorily perform each essential duty and other duties as assigned.

• Experience:  Associate degree in a technical field such i.e. Mechatronics, Electronics Technology, Electrical Systems, Computerized Control Systems, or Industrial Maintenance Technician is preferred.  Alternatively, 5 or more years related manufacturing mechanical maintenance experience and/or maintenance of facility systems equipment.
• Professionalism: Consistent performance as a professional, effective, and positive member of the department and organization.
• Communication:  Strong verbal and written communication skills; ability to interact effectively with all team members, management, internal customers, contractors, suppliers, vendors, and engineering.
• Schedule:  Flexibility to alter or adjust work schedules or locations is required in order to meet the demands of the business.
• Emergency Schedule: The ability to respond to on-call emergencies is required.
• Skills: Ability to confidently and accurately utilize a wide range of core facility maintenance, industrial repair, and/or trade skills
• Time Management: Organization and prioritization skills; ability to manage multiple priorities based on business needs.  Skill with risk assessment and mitigation.

Abilities

• Language: Read and write English with good comprehension, comprehend instructions, understand short correspondence.  Clearly write correspondence.  Effectively present information in one-on-one and small group situations to other employees of the organization.
• Math: College level algebra is beneficial.  Ability to add, subtract, multiply, and divide, in all units of measure and in basic mathematical formulas, using whole numbers, common fractions and decimals.
• Reasoning: Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Deal with problems and/or situations involving several variables.
• Computer Skills: Intermediate level skills for clerical and administrative procedures and systems such as computer functions, word processing, spreadsheets, e-mail, internet, managing electronic and hardcopy files and other basic tasks.
• Certificates and Licenses: Professional Certification in a discipline such as: Pneumatics / Hydraulics, Electrical Systems, PLCs Robotics, Control Systems, or other electro-mechanical disciplines is beneficial.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms and stoop, kneel, crouch or crawl.  The employee is frequently required to stand; climb or balance and talk or hear.  The employee is regularly required to lift up to 10 pounds.  The employee is at times required to lift to 40 pounds.  The vision requirements include close vision, distance vision, peripheral vision, and depth perception.  (Note: distance vision, peripheral vision and depth perception are requirements for PIV Operators only.)

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is frequently exposed to dust airborne particles.  The employee is occasionally exposed to moving mechanical parts and high places.  The noise level in this environment is moderate.

SUMMARY:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

• Lead PE representative on project.  Provide input on resources needed and project planning.
• Attends and arranges project meetings to discuss current and future design and development initiatives.
• May serve as a primary contact with clients on projects of moderate complexity.
• 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. Track and communicate project status, plans, issues, timelines, action items, and budgets.
• Provide guidance and direction to coworkers on areas of technical expertise.
• Troubleshoot production processes as required.
• Evaluate and select appropriate test methods for product requirements
• Responsible for the following project inputs:
  • Feasibility builds, documentation, and testing
  • Equipment selection
  • Process development and documentation
  • Device Verification samples and testing
  • Operator training
  • Process Failure Mode Effects Analysis
  • Clinical builds
  • Process Validation
• Involvement in the full design, development, and validation requirements of projects, including:
  • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
  • Materials sourcing and device prototyping.
  • Design verification and validation activities, including data for regulatory submission
  • Manufacturing transfer and support of existing product lines as applicable.
• Other duties as assigned.

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.
• Must maintain high ethical standards
• Must demonstrate good organizational skills.
• Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
• Must be able to read, write and speak fluent English.
• A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience; or equivalent.
• 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.

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.

SUMMARY:

This position is primarily responsible for utilizing state of the art equipment for the development of life changing medical devices.  The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development.   Lastly, the technician must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program.

Responsibilities:

• Run equipment tests, collect data and analyze data with the engineering team.
• Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
• Ability to diagnose and solve problems with jobs in a timely manner.
• Assist in training employees on equipment and assembly skills.
• Interact effectively and assist engineering in improving quality and solving problems.
• Develop processes and procedures for projects to improve quality and cost.
• Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience.
• Represent engineering for Material Review Board concerning material dispositions.
• Represent Engineering in cross functional teams as assigned.
• Maintain compliance to procedures and regulatory requirements.
• Understand and follow safety policies and practices, attend safety training and wear PPE as required.
• Prepares Engineering Change Orders for processes and components.
• Performs Corrective and Preventative Action tasks.
• 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:

• Strong drive to learn, share and teach.
• Understanding of and experience with mechanical equipment.
• FDA, cGMP principles and practices, (ISO 9001, ISO 13485).
• 3 Plus years’ experience in the engineering/manufacturing environment for medical devices.
• In-depth understanding of one or more manufacturing processes is a plus.
• Familiarity with Pro-E / CREO and or SolidWorks is preferred.
• Strong computer skills associated with Microsoft software.
• Ability to interpret technical drawing, blueprints, specification and illustrations.
• 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 strong team collaboration skills.
• Must be able to make clear and accurate decisions.
• Strong desire to learn and apply new technology.

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.

SUMMARY:

This position is primarily responsible for manufacturing processing, inspection, standard documentation and packaging of products. The Technician I works under the direction of the Production Team Leader and the upper level Technicians they are assigned to assist or be trained by.  This position is designed to augment the ability of the Technician’s and other manufacturing personnel to meet goals for quality and production rates in a cost-effective manner.

Responsibilities:

• Primary function of assisting production operators and technicians engaged in processing and product fabrication.
• Will be proficient in the task of loading components into product specific tools.
• Demonstrates strict adherence to all safety, GMP & quality system guidelines.
• Has the responsibility of following established documentation for product manufacturing.
• Must accurately document all work performed on inspection reports and customer travelers.
• Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
• Performs pre-weld operations such as assembly and part cleaning.
• Performs various post-weld operations such as cleaning or post weld assembly.
• Assists in packaging of finished goods as needed.
• Maintains cleanliness of work areas, machines, tools and equipment.
• Assists Quality Control with inspection duties as required.
• Performs other duties as assigned by the Production Manager.
• Takes direction within the manufacturing cell from upper level Technicians assigned to that cell.
• Performs workstation set-ups with assistance from qualified technicians.
• 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:

• Must be able to read, write and speak fluent English.
• High school diploma or General Education Degree (GED) is required.
• Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

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.

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.

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 facility in Los Gatos, CA, the Manufacturing Engineer will be mainly responsible for manufacturing process development, launching new products into clinical and/or pilot production and supporting sustained production.

Responsibilities:

• Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products
• Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
• Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
• Develops manufacturing process instructions, inspection plans and lot history travelers
• 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)
• Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
• Manages and/or supports production and test equipment maintenance, qualification and calibration
• 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, leads investigation to determine root cause and implements effective containment and counter measures
• Dispositions non-conforming products and develops required re-work procedures
• 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
• 5+ years of experience in medical device process development and/or manufacturing engineering
• Experience with capital electromechanical products (involving circuit boards and displays) preferred
• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred
• Solid knowledge of GMP and ISO 13485 regulations
• Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.
• 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

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 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.

SUMMARY:

This position is primarily responsible for working in a functional engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

• Attends and arranges project meetings to discuss current and future design and development initiatives.
• May serve as a primary contact with clients (internal and external).
• Assist with preparation of proposals and quotations. May be required to interface with clients 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
• Designs flex circuits, rigid flex, and PCB circuits using customer supplied data, schematics, Gerber files, and component specifications.
• Creates 2D and 3D CAD models of circuitry using SolidWorks, Altium, and other applicable software
• Manipulates electronic data files using Gerber, OB++, various CAD packages, and 3D modeling such as AutoCAD and SolidWorks
• Establishes electrical functionality (current, Isolation, and stack up requirements)
• Specifies components, solder, underfill, and cover lay materials use on circuit assemblies
• Define and review test requirements to verify circuit performance
• Designs and specifies test fixtures in support of circuit performance verification
• Specifies metal schemes, base materials and other features as related to circuit performance
• Troubleshoots existing designs in support of sustaining manufacturing
• Defines and maintains electronic library in support of company’s standard offerings
• 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:

• Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
• Able to follow cleanroom and ESD policies, become familiar with and practice 6S principles in order to maintain a safe, neat, and orderly workplace.
• 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 Electrical Engineering and minimum 4-years appropriate work experience; or Associates degree in Electrical Engineering and a minimum or 6-years appropriate work experience; or a minimum 10-years relevant work experience; or equivalent.
• Must have working knowledge in analog and digital circuit and system design
• Experience with electrical and mechanical interfaces (connectors, mechanical aspect of PCBs, flex circuits, wire-harnesses, fuses, indicators etc.)
• Must have working knowledge of in electronics engineering principles and methods is a must; knowledge of design standards IPC-2220 series and acceptability for electronic assemblies per IPC-A-610C
• Must have a working knowledge of printed circuit board CAD data and assembly equipment programming software, and databases.
• Strong computer skills, including the MS Office suite and MS Project.
• 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.

Protective Clothing Required: Standard PPE and cleanroom garments

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.