Careers with Cirtec – Medical Device Design, Development and Manufacturing

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

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.

Current Opportunities in East Longmedow, MA

Manufacturing Engineer

Summary:

Manufacturing Engineer needed to define and develop processes for medical device products, prior to introduction into standard production. Also lead process improvement efforts and day-to-day maintenance of production product.

Responsibilities:

  • Plans, schedules, conducts and coordinates detailed phases of engineering work in projects for new and existing products. Makes suggestions for and may implement improvements in operating time, yields, ergonomics, handling, etc.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Writes/updates work instructions, part specifications, validation protocols, technical documents and various forms of reports and correspondence.
  • Serve as team champion for Design for Manufacturing and Assembly (DFMA) considerations.
  • Performs design review and pre-validation assessments to ensure the safe and environmentally sound startup of new processes, communication business related issues or opportunities to upper level management.
  • Develops and implements process improvements for current production products.
  • Troubleshoot production processes when part failures occur.
  • Communicate with customers on project updates, process improvements or manufacturing changes.
  • Participates in the development of new products, works with customers to understand their requirements.
  • Prepare periodic reports on project activities.
  • Comply with all documentation procedures for regulatory compliance.

Requirements:

  • Bachelors of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 3 years.
  • Familiarity with FDA cGMP principles and practices.
  • Experience in Design for Manufacturing.
  • Experience in experimental techniques including statistical analysis, DOE and validation.
  • Possess a solid understanding of engineering theoretical fundamentals including a basic knowledge of precedents in the manufacturing area.
  • Proficiency with SolidWorks and experience with complex mechanical and electrical assemblies.
  • Ability to work with design requirements, suitability of conventional materials and coordination requirements.
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Experience with Six Sigma or process excellence methodologies preferred.
  • Experience with injection molded, extruded and machined parts, as well as emphasis on miniature/small scale components helpful.
– email [email protected]

Quality Engineer

Summary:

Quality Engineer needed to support complex projects and products. This multi-faceted role will require independent work, while collaborating on project teams to meet customers needed. The QE with interact with external and internal customers and suppliers in support of projects.

Responsibilities:

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

Production:

  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures. Interact with customers and suppliers to resolve CAPA investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Perform other duties as necessary.

Requirements:

  • Bachelors of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2 years (BS) OR 4 years (AS) OR 7 years (ND).
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
– email [email protected]

Strategic Sourcing Manager

Summary:

The Strategic Sourcing Manager is responsible for the development and execution of sourcing strategies to leverage relationships within business entity or across enterprise to achieve best total value. Leading the negotiations and supplier management with company supply base, driving the strategic sourcing process across multiple sites. Leading and supporting the development, implementation and management of supply chain strategies providing optimal supply assurance, pricing, and flexibility, quality and delivery performance.

Responsibilities:

  • Builds and leverages strong working relationships with internal customers and key suppliers to assure cost, quality, and delivery targets are met. As the primary supplier relationship owner, responsible for negotiating prices, terms and conditions, risk mitigations and warranties in support of those agreements.
  • Communicate and implement strategies, contracts, and pricing with an overall focus on maintaining good supplier relationships and minimum total cost of ownership to achieve maximum advantage for the company and its customers.
  • Develop key performance measures for chosen suppliers and negotiate on multiple variables to award longer-term strategic contracts that result in significant cost reductions and improved service levels.
  • Analyze current spend and evaluate current suppliers. Consolidate spend to create leverage, analyze purchasing trends and develop sourcing alternatives.
  • Support new product introduction (NPI) programs by coordinating all sourcing and supplier qualification activities across sites.
  • Researches, identifies, and analyzes current and emerging procurement trends, develops a deep understanding of market conditions, proposes global supply chain solutions focusing on total cost of ownership.
  • Works closely with Finance to ensure proper segregation of duties with respect to Supply Chain. Creates policies and programs as needed to ensure compliance with Cirtec directives.
  • Familiar with customs regulations for import of products from foreign countries.

Requirements:

  • BA/BS, +5-7 years of work experience or MBA, + 3-5 year minimum relevant work experience with in the medical device industry.
  • Extensive knowledge of supply chain planning, sourcing, inventory management, purchasing, logistics & experience in working with engineering and quality teams to collaborate on supplier development.
  • Experience working with a medical device contract manufacturer desired.

This position can be located in either Minneapolis or East Longmeadow, MA.

– email [email protected]

Current Opportunities in Los Gatos, CA

Principal Systems & Electrical Engineer

Summary:

The Principal Systems & Electrical Engineer will provide Systems Engineering expertise and functional supervision to the Electrical Engineering Department. This person will direct, lead and manage the technical activities of system design, requirements management, electronic design, hardware reliability and system integration for multi-disciplinary medical device technologies. This person will become actively involved in the design and development of products as required to meet schedules and resolve problems.

Responsibilities:

  • Develop electronic and electromechanical specifications, test plans and verification reports.
  • Develop, model, analyze and design electronic and electromechanical subassemblies.
  • Perform and document system performance and budget analyses (tolerance stackups, error budgets, power, weight and cost breakdowns, etc.)
  • Provide support and supervision to direct reports and contractors for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.
  • Serve as a principal contact with clients; arrange meetings to discuss upcoming projects, instilling confidence in our technical capabilities and quality products.
  • Organize a project plan to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Maintain project and product cost.
  • Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversee the process of preparing new or modified products ensuring compliance to internal and customer requirements.
  • Provide leadership of multi-disciplined teams that will execute projects from the development phase through production.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Interface with quality engineering to help maintain accurate policies and procedures and respond to audit findings.
  • Identify Electrical Engineering resource needs for programs and assist in recruiting appropriate talent.
  • Other duties as assigned.

Requirements:

  • BS/MS in Electrical Engineering or a related engineering discipline.
  • Experienced with Systems Engineering and Requirements Management.
  • Familiarity with and ability to manage projects involving embedded microcontrollers, hardware architecture, embedded software design, motor and control feedback circuits, sensors, mixed signal circuit design and PCB layout.
  • Ability to work with a wide variety of people, including Manufacturing, and QA, as required accomplishing results with little overall guidance.
  • Strong verbal and written communications skills to effectively prepare specifications, protocols and reports and formal presentation skills.
  • Minimum of 5 years of product development leadership with a demonstrated ability to lead projects successfully from early stage development to production.
  • Minimum of 10 years in systems and/or electrical engineering design and development, preferably for Class II or Class III medical devices.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, specifications and illustrations.
  • Will attend technical classes and seminars as required to enhance job performance.
– email [email protected]

Process Development Engineer

Summary:

The Process Development Engineer will be responsible for the development and manufacturing of mechanical designs for the creation of external and implantable medical devices.

Responsibilities:

  • Applies engineering knowledge and skills as technical engineer for all phases of development projects.
  • Participates in the creation of specifications and develops designs to meet those specifications.
  • Participates hands-on in developing prototypes.
  • Generates and executes test protocols to verify functionality.
  • Creates and releases medical device manufacturing process instructions, bill of materials, lot history travelers, and related documentation.
  • Sometimes coordinates and schedules other staff to work on specific tasks.
  • Communicates directly with clients to understand needs and present results.
  • Effectively interfaces with and manages suppliers to fabricate prototype and final design components.
  • Participates in product risk management and develops and implements risk mitigation strategies.

Requirements:

  • Minimum BSE/BSME with 2-5 years of experience within the Medical Device industry.
  • Knowledge of materials and processes used in manufacture of catheters and other medical devices preferred.
  • Experience in creating product specifications, test protocols, manufacturing procedures.
  • Experience with SolidWorks.
  • Excellent communication skills both written and oral.
  • Familiarity with medical device design control processes.
  • Familiarity with medical device packaging systems and related testing.
– email [email protected]