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Instrumentation Laboratory Jobs In Bedford, MA

- 37 Jobs
  • Customer Service Coordinator I

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Under general supervision, the Customer Service Coordinator I is responsible for performing front and/or back office support functions for the Customer Service Team. This includes responding to all incoming customer phone calls, fax and email order and inquiries. Serves as the first point of contact for the customer, and escalates customer's issues to team management as necessary. Responsibilities Key Accountabilities: Responsible for responding to all customer questions via phone or assigned in task system in a timely and professional manner Processes customer orders as received via phone or task system and ensures accuracy and alignment with department guidelines and processes; escalates order inquiries as necessary Interacts with distribution and planning personnel on product status availability and advises customers accordingly Reviews and processes Technical Support requests for replacement products; responsible for following up with Technical Support to ensure resolution Coordinates with the appropriate parties when lot-specific requests are made. Ensures that all orders are released for shipment following product shipping guidelines. Responsible for ensuring proper documentations accompanies all orders prior to final order submissions Regularly reviews task system and assigns orders and/or inquiries to fellow Customer Service Coordinators depending on geographical coverage or special assignments Ensures that all requests for standing orders and overnight shipments are properly labeled Manages personal task queue ensuring that all customer orders are processed within departmental timeline goals. Follows-up on all customer inquiries, account maintenance requests, price discrepancy tasks, shipping issues, etc. Prepares customer quotations for Werfen products based on pre-established pricing guidelines. Works with logistics team to coordinate shipping for returns or replacements, ensuring inventory adjustments and credits are processed accurately, in accordance with department procedures. Researches and resolves invoice discrepancies reported to Credit and Collections team. Processes credit and/or debit memos in accordance with departmental procedures. Prepares and distributes various customer reports on a regular basis Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs, to include interactions such as: Customer Service Distribution Management Technical Support Logistics, Warehouse & Planning Credit and Collections North America Commercial Operations, including Sales & Clinical Applications, Product Marketing IT Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Strong customer service and interpersonal skills Strong written and oral communication skills Ability to navigate and manage customer complaints and objections Strong problem solving Proven attention to detail Ability to analyze and apply sound judgement to issue resolution Good time management skills; Ability to prioritize and organize workload in a fast paced environment Qualifications Min Knowledge & Experience Required for the Position: Education: Associate degree in Business or related field required. Bachelor's degree in Business Administration, Finance, or related field preferred, or equivalent experience Experience: Previous experience in a customer service role or environment preferred Additional Skills/Knowledge: Basic Microsoft Office skills required. Basic pivot table knowledge a plus Ability to navigate in an SAP ERP System preferred Language: Fluency in English required International Mobility Required: No Travel Requirements: Approximately
    $41k-50k yearly est. 12d ago
  • Service Operations Manager

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary: Provides leadership and strategic direction within the North America Service and Support organization. Manages internal and external Service and Support operation functions for US and Canada and acts as the liaison between the functional units within the company and the North America Commercial organization. Develops and implements all critical business operating procedures within the North America Commercial Service organization with focus on continuous improvement of customer support and satisfaction. Responsibilities Key Accountabilities: Essential Functions: Develops and implements policies and procedures for the North America Service and Support Organization Creates and utilizes service support metrics and works with field service management to assess personnel requirements, customer satisfaction levels and monitor and evaluate the performance of the North America service organization Coordinates with internal support departments, including North America Commercial Operations, Client Services, IT, Strategic Business Unit, RA/QA, Manufacturing, and Finance to develop and implement cross department processes required to improve North America Service Operations to maximize service efficiency, increase service revenue, and control operating costs Assist Field Managers to resolve complex service operation and business problems by making solid decisions collaborating with the field service management and internal support staff. Develop and implement a plan of action based on the above Other duties as assigned Secondary Functions: Develops and implements with finance the cycle count process to ensure accurate inventory Works with Service Leadership and Finance to prepare annual service operational budget Reports to senior management the performance/statistics for the North America service and support organization Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs, to include interactions such as: Client Services IT Finance Quality Assurance and Regulatory Affairs Strategic Business Unit Commercial Operations Manufacturing Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Strong Leadership Strategic business planning, ability to execute tactically Highly accountable and drives accountability Ability to communicate and present across all levels of the organization Strong verbal, written and presentation skills. Strong motivational, interpersonal and leadership skills Ability to effectively manage multiple priorities in a fast paced and deadline driven environment Process oriented with focus on continuous improvement Werfen People Manager Competencies: (applicable if in a People Manager Position) The following competencies form part of the competency model for People Manager at Werfen and form part of our mindset around People Management and Leadership. We expect all People Managers of Werfen not only to demonstrate, but also to constantly continue to develop, the following competencies: Building Talent: Planning and supporting the development of individuals' knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively. Customer Focus: Ensuring that the internal or external customer's perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities, crafting and implementing service practices that meet customers' and own organization's needs; promoting and operationalizing customer service as a value. Decision Making: Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences. Driving for Results: Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement. Driving Innovation: Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external) ; encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions. Emotional Intelligence Essentials: Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others' emotions and behavior; leveraging insights to effectively manage own responses so that one's behavior matches one's values and delivers intended results. Qualifications Minimum Knowledge & Experience Required for the Position: Education: Bachelor's degree in Business or Science (Chemistry, Biology, Biochemistry) or Engineering and or equivalent experience. An MBA is highly desirable. Experience: Seven years in a sales, service/support or managerial capacity Additional Skills/Knowledge: Project management experience is desirable. A solid understanding of business systems, computer hardware and software Language: Specific to country and role´s needs International Mobility: Required: Yes Travel Requirements: Up to 50% of time Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. **************
    $91k-119k yearly est. 12d ago
  • Engineering Applications Support Specialist (Design & Software Tools)

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Main interface between the Hardware Engineering Department (HWE) and the Werfen Bedford IT Systems Organization, with responsibilities for technical user support for HWE, including administration and support of CAD/Windchill and ALM software. Monitors and controls HWE data communications equipment and software. Maintains HWE hardware and software on the company's network servers and user workstations and keeps hardware and software inventory. Responsibilities Key Accountabilities Essential Functions: For Hardware Engineering (HWE) users: Acts as the main interface with the IL Bedford IT Systems Organization to communicate with, assist with, and resolve HWE department system or network issues. Keeps an up-to-date hardware inventory, including a hardware configuration database for new workstation procurement, and for renewal/upgrade tracking. Directly communicates with the IL Bedford IT Systems Organization for hardware procurement. Keeps an up-to-date software inventory, including an up-to-date list of licensing configurations, pricing and capabilities. Manages use of these licenses at the user level, and proposes yearly additions or subtractions based on utilization metrics and forward-looking department initiatives. Coordinate with other departments to meet other ALM needs. Administer users and licences for ALM software. Participate in Werfen-wide initiatives for ALM software governance and evolution strategies. Software and Licensing administration incudes: ANSYS, PTC/Creo, SolidWorks, MathCAD, MATLAB, PTC ProductView, PTC University, Cockpit, JAMA. Helps establish and improve policies, procedures, workflows, and best practices related to HWE systems. Participates in CAD/Windchill Application Engineering toolkit development. Installs and tests hardware and software for workstations, printers, and other peripheral devices in HWE employee work areas. Diagnoses causes of failures and performs corrective or preventive maintenance with assistance from the IL Bedford IT Systems Organization. When necessary, coordinates service calls to outside vendors, reporting problems and assisting with the repairs. Interfaces with partners and consultants for maintenance, support, and enhancement of HWE tools as well as the monitoring of network servers to support software licensing and hosting. Assists HWE employees in operation of personal computers, printers and other peripheral equipment. Secondary Functions: • Performs other administrative tasks as required by the IL Bedford IT Systems Organization. Budget Managed (if applicable) • N/A Internal Networking/Key Relationships To be determined based on department needs, to include interactions such as: • All users within Hardware Engineering • Regularly meets with systems users to clarify user requirements, provide support and problem resolution. • Regularly meets with the IL Bedford IT Systems Organization to clarify user requirements and problem resolution. • Coordinates with IT Systems Senior Manager or IT Systems Manager in the IL Bedford IT Systems Organization on project priorities and to establish the design for the different infrastructure projects. • Also works with external ALM service providers to increase the specialization and quality of the services provided. Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: • Ability to troubleshoot hardware/software malfunctions and perform repairs is required. • A good understanding of engineering product definition, Bills of Material (BOM), configuration management, library management, and change control is required. Qualifications Minimum Knowledge & Experience Required: Associates or Bachelor's Degree in design technology or equivalent technical subject or three years of equivalent work experience in a similar position are required. Minimum of 3 years' experience in a similar position required Working knowledge of computer hardware and operating systems, servers, computer networks, and peripheral equipment. Experience with technical support and configuration of Windchill/Creo, JIRA, Confluence, and JAMA (similar web-based tool) and its system interfaces. Experience supporting applications in a cloud/datacenter environment. Experience with Programming Languages (C++, Basic, JavaScript, HTML, JS, CSS). Experience in the Microsoft Power Platform (PowerApps, PowerBI, PowerAutomate, PowerQuery) Experience with routine activities for Applications administration, maintenance, and backups like backups, Experience creating and/or maintaining Node.js applications International Mobility Required: No Travel Requirements: Up to 5% of time
    $89k-112k yearly est. 12d ago
  • ACDx Marketing Intern

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    The purpose of the internship is to provide meaningful professional hands-on experience to students with leadership potential and proven academic performance. Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities. Responsibilities Position Description To perform entry level work of a routine nature requiring application of standard techniques, procedures and criteria in carrying out a sequence of related tasks. The Intern will be involved in the day-to-day activities of the team included aiding other departments as they relate to department projects. We expect the intern to gain an in-depth knowledge of the product and its associated processes, particularly the process activities in-which they will be directly involved. The intern will have opportunities to assist in nearly all aspects of the workflow. Key Attributes Requires confidence in using Microsoft Word and Excel tools. Requires Enthusiasm, motivation, initiative and ability to work within an interactive and energetic workplace. Review process procedures, change orders, equipment specifications, validation plans, and reports. Performs research on technology, equipment and tooling to improve process quality, yield or cost. Generates proposals based on research. Assistance in creating, reviewing and maintaining department files. Performs experiments, analyzes and interprets numerical data from experiments. Summarizes findings by computer readouts, statistical summaries, graphs and other methods. Qualifications Minimum Knowledge & Experience Required for the Position: Currently pursuing B.S. in Engineering, Finance, Business, Marketing with a minimum of 2 college semesters complete. Ability to multitask.
    $35k-43k yearly est. 12d ago
  • Product Security Officer

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary: The Werfen Product Privacy and Security Program is a shared service model with responsibility for Cybersecurity and Privacy by Design, Compliance, Security Testing and Incident Response. As a Werfen Product Security Officer you are responsible for cybersecurity and privacy functions for our Products. The role teams on Werfen Projects to ensure the product privacy and security posture. This role is a trusted collaborator of the Project Teams and work closely with Quality and Regulatory functions. Responsibilities Responsibilities Key Accountabilities include but are not limited to: Represent the Werfen Product Privacy and Security Office. Responsible for leading Product cross functional team members to complete all technical aspects of product cyber security tasks and initiatives. Represent cyber security with the product development teams to ensure cyber security and privacy is being designed into products. Represent cybersecurity and privacy in the Risk Assessment. as a subject matter expert including: cyber security threat management process, Continuous technical analysis and monitoring of cyber security signals. Participate in customer assurance. This includes Product Security communications content such as: Product Labeling, completion of security inquiries, complaint and vulnerability reports, provide consistent cybersecurity and privacy guidance to Werfen and Customers. Qualifications Qualifications Minimum Knowledge & Experience Required for the Position: 12-15 years of Cybersecurity and/or Privacy Compliance 5 years' experience leading product cyber security projects and risk management activities - in medical device or healthcare domain. Experience in cross-functional cyber security activities including Product Defense in Depth, security technology, regulatory compliance, and incident response Domain specific standards and approaches on privacy and product security (ISO 2700x, NIST 800 Series Special Publications) Knowledgeable and experience with laws and regulations on cyber security, privacy, data protection and breach notification (e.g.: FDA cyber security guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971. AAMI TIR 57; 21CFR820, SB1386, etc.) Experience in designing or leading software products using Secure SDLC. Thorough Understanding of securing and hardening Windows and Linux operating systems Thorough understanding of networking and network security If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. **************
    $35k-43k yearly est. 12d ago
  • Group Product Manager- Medical Device

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary: Under the direction of the department Director oversees the day to day management of the marketing staff for the product line. Prepares strategic marketing activities and programs for all supported products. Provides marketing assistance and support to affiliates, distributors and customers. Responsibilities Key Accountabilities: Prepares and works with marketing teams on marketing programs for assigned product line. Contributes, through the marketing staff, to planning and creation of advertising and promotional materials and technical information. Promotes, through the marketing staff, the generation of technical publications on products and applications. Provides and oversees the analysis of competitive products, pricing, selling techniques. Provides and oversees market research to define and assess opportunities for new products. Stay informed about developments and testing in medical diagnostic industry as they apply to the company's future marketing plans and products. Coordinates cross department (R&D, QA, Regulatory, Manufacturing, Commercial Operations, Marketing) efforts related to on market analyzers and tests and production planning. Understands the technical aspects of IL and competitive products. Understands the regulatory requirements for assigned products. Oversees, coordinates the training needs of marketing staff Budget managed (if applicable)- N/A Internal Networking/Key relationships To be determined based on department needs Skills & Capabilities: Strong Functional management skills and ability to hire and develop team members Strong technical skills and the ability to learn new technologies as required Conflict management skills, timely decision making ability, strong business acumen Qualifications Min Knowledge & Experience Required for the Position: Bachelor's degree in applicable technical discipline such as medical technology, biomedical engineering or equivalent. An MBA is a plus. Minimum 5 years of experience in product marketing, marketing and/or sales management Practical knowledge of Hemostasis or Critical Care as it relates to the assigned product line International Mobility Required: no Travel Requirements: Some travel required up to 25% Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. ************** #LI-Hybrid
    $123k-158k yearly est. 6d ago
  • Scientific Group Leader II

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Performs a broad range of technical assignments requiring application of professional judgement in the selection of specialized methods and techniques, and their application to specific project tasks higher than or equivalent to Senior Scientist II level. Responsible for assigning and overseeing the tasks of junior scientists (Scientist I to III) or lab technicians in new product development or in released product support projects. May act as group leader or lead scientist on a small project or be responsible for a number of smaller projects. Acts as a coach and mentor for junior scientists in training project specific technologies, preparing protocols and reports and in supporting other department level activities. Responsibilities Key Accountabilities Essential Functions: Manages multiple scientists (Scientist I to III) and/or technicians, and organizes their day to day activities, sets priorities within the group, and holds group accountable to agreed timelines. Responsible for yearly review of department personnel and provides recommendations for required training and career development. Provide updates to functional manager as required. Applies scientific method and experimental design in problem solving. Uses scientific expertise to provide solutions to a broad range of difficult problems. Solutions are original, thorough and practical. Frequently communicates progress status to supervisor. Performs complicated or demanding assignments requiring specialized knowledge. May offer solutions that are creative and/or inventive. Defines short and mid-term objectives and implements plan to accomplish objectives. Maintains accurate, precise, and legible laboratory notebooks. Frequently communicates status updates across the organization. Maintains good documentation. Writes reports and technical summaries. May represent the company to outside organizations. Continually broadens professional expertise through comprehensive knowledge of scientific literature and competitive products. Handles broad assignments and objectives under minimum supervision. Accomplishes short-term objectives. Contributes to departmental goals and is a team player. Working knowledge of design control processes and experience in data collection for supporting regulatory submissions. Secondary Functions: N/A Budget Managed (if applicable): N/A Internal Networking/Key Relationships: Responsible for managing multiple scientists (Scientist I to III) in new product development and released product support projects. Skills & Capabilities: Relevant technical skills, interest in team management, effective in problem solving, building cross-functional relationships and communication skills. Werfen People Manager Competencies: (applicable if in a People Manager Position) The following competencies form part of the competency model for People Manager at Werfen and form part of our mindset around People Management and Leadership. We expect all People Managers of Werfen not only to demonstrate, but also to constantly continue to develop, the following competencies: Building Talent: Planning and supporting the development of individuals' knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively. Customer Focus: Ensuring that the internal or external customer's perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities, crafting and implementing service practices that meet customers' and own organization's needs; promoting and operationalizing customer service as a value. Decision Making: Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences. Driving for Results: Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement. Driving Innovation: Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external) ; encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions. Emotional Intelligence Essentials: Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others' emotions and behavior; leveraging insights to effectively manage own responses so that one's behavior matches one's values and delivers intended results. Qualifications Minimum Knowledge & Experience Required for the Position: Education: Knowledge acquired through a Bachelor's, Master's or Ph.D. Degree. Experience: Bachelor's plus 8 years of relevant experience or Master's plus 6 years of relevant experience or D. degree plus 2 years of relevant experience A minimum of 2 years of experience in managing junior level scientists. Additional Skills/Knowledge: Must have a demonstrated interest in managing a product development effort. Works independently on tasks designated by management, has effective time management skills, and maintains good working relations within the R&D Department and across departments. Strong oral and written communication skills. Must demonstrate the ability to perform all duties and responsibilities higher than Scientist Senior Scientist II level. International Mobility: Required: No Travel Requirements: Approximately 10% of time
    $108k-144k yearly est. 12d ago
  • Associate Training Specialist

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    This position assists with developing, implementing, and maintain training materials, programs and records that focus on improving the competencies of team members to ensure compliance with regulatory requirements, written procedures and role-based training requirements. Works proactively to ensure that required training is identified, assigned and completed by affected team member to meet Quality and corporate objectives, and to reduce process deviations and support the production of quality products. This role also supports employee learning and development by providing support and guidance to stakeholders on various types of learning interventions. Responsibilities Key Accountabilities: Assists with the development and maintenance of role-based training requirements by functional group. Supports Training Group owners to ensure group definitions and training requirements assigned to the group meets the needs of the company and the minimum needs for compliance Assists with reviews of new and revised procedural documents and consults with originators and training group owners to ensure compliance with training requirements and alignment with roles. Assists with training needs requests, from origination to development and implementation, to tracking of session completion in SAP and following up with Functional Managers as necessary. Provides feedback to stakeholders on creating learning interventions following the ADDIE model and incorporating adult learning principles, including use of a template library. Provides administrative support for employee learning platforms. Other items as assigned. Networking/Key Relationships: To be determined based on needs but could include interactions with all departments. Qualifications Minimum Knowledge & Experience Required for the Position: Education: Bachelor's degree or related equivalent experience Experience: This is an entry-level position requiring a minimum of 1 year of relevant work experience. Must be proficient with Microsoft Office suite. Experience with ERP systems desirable. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Desire and aptitude to quickly learn and apply new knowledge and skills Flexible, organized and able to manage time; balances priorities and meets assigned deadlines Customer-focused and able to interact effectively with a diverse range of people at multiple organizational levels Strong verbal and written communication skills Attention to detail Works independently and as part of a team Analyzes situations, thinks creatively, and asks thoughtful questions Travel Requirements: Approximately 5% of time
    $80k-110k yearly est. 12d ago
  • Field Service Engineer I

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Amazing Total Rewards for our Field Service Engineers! Generous Base Salary + Incentive Compensation Company Vehicle with Personal Use Allowance Phone & Internet Reimbursement 8% 401k Match (dollar for dollar!) Comprehensive Health Care Benefits Company paid Life Insurance Flexible Spending Account (FSA) Tuition Reimbursement Talk to your recruiter for full offerings! Position Summary: Under direction of the Area Service Manager, develops customer satisfaction through technical repair, installation, training, operation, and maintenance of Werfen instruments and systems. Position may have a specific assigned territory or system population or may be a position to cover other assigned territories as needed under the direction of the Area Service Manager. Responsibilities Key Accountabilities: Provides highly visable customer support through the performance of on-site installations and neccessary diagnostics. troubleshooting, service and repairof complex instruments and systems. Performs routine and some non-routines technical repairs of all systems. This includes updates, retrofits, PMs and product enhancements. Instructs customers in the proper operation, maintenance and troubleshooting of Werfen instruments and systems Is responsible for complying with all appropriate regulatory bodies (FDA, ISO and Health Canada) mandated policies, procedures, work instructions, and records Serves as a company liaison with customers. Responsible for routine interaction with sales counterparts with respect to cusstomer situations, updates, and lead generation Assures financial stability and viability of territory by promoting and selling service agreements, PMs, and other services Other duties and responsibilities as assigned by the Area Service Manager Budget Managed (if applicable) N/A Internal Networkign/Key Relationships TBD based on departmental needs Skills & Capabilities: Approachability; Command Skills; Listening; Presentation Skills; Functional/Technical Skills Qualifications Min Knowledge & Experience required for the position: Associates Degree in Electronics, Biomedical Engineering, Medical Technology or related industry. Must posses some organizational skills, the ability to multi-task, work under pressure and exercise good judgment. Ability to communicate effectively with customers, peers and management through oral and written presentations / reports Must have some basic MS Office Skills (Word, Excel and PowerPoint) including the ability to manipulate data and build presentations Travel is required. International Mobility Required: no Travel Requirements Minimum 30% by auto in primary assigned territory. Minimum 10% by air for training, business meetings and/or support to customers outside primary or assigned territory.
    $72k-101k yearly est. 10d ago
  • Principal Regulatory Affairs Specialist

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Job Summary The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing regulatory strategies and plans throughout the lifecycle of the SaMD products. This role acts as a subject matter expert that helps to ensure compliance with applicable international regulations in which the company does business; preparing product regulation plans and submission documentation for international markets and evaluating product changes for effects on regulatory license registrations. Responsibilities Key Accountabilities (Digital Factory Products) Conceive of and Implement the Regulatory Strategy in collaboration with Cross-Functional (Solution Leaders, SBU Marketing, Medical Affairs, BU Regulatory and other) partners. Collaborate with Digital Solutions QA to implement changes in the Quality Management System to support the Regulatory Strategy. Assess Software Safety Classification. Prepare regulatory plans assessing worldwide country registration requirements. Act as the liaison and point of contact for all Digital Factory interactions and communications with Regulatory Agencies and Notified Bodies. Author and support regulatory filings for market clearance, licensing, registration, and legalization. Support the development and maintenance of Technical Files, Design Dossiers, Design History Files and Product Files. Provide Regulatory guidance to Product Development Teams during New Product Development and change implementation. Assess product modifications for regulatory impact, prepare needed submissions and review and approve related change orders. Review and approve labeling and other product marketing promotional materials related to new products and significant changes. Support Product related Third-Party Audits. Author post-market surveillance reports. Support changes to regulatory procedures in alignment with evolving Technologies, Regulations and Standards. Networking/Key Relationships SBU Marketing Medical Affairs BU R&D BU Regulatory Solution Leaders Digital Solutions QA Legal Other Werfen departments as needed Qualifications Minimum Knowledge & Experience required for the position: Education: Bachelor's degree or higher, in Science, Engineering, and Regulatory. Experience: Minimum of 10 - years' experience in regulatory approval processes for medical devices or in vitro diagnostics, with at least 5 years related to software as a medical device (SaMD). Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Advanced knowledge of FDA, MDSAP, IVDR, MDR and international regulations, as well as ISO 13485 and other international standards Experience working with Artificial Intelligence Product submissions desirable. Regulatory Affairs Certification (RAC) desirable. Ability to thrive in a fast-paced, technical, and mission-focused Agile organization. Works closely with other functions to generate Regulatory documents in alignment with quality procedures related to applicable Regulatory requirements, standards, regulations, and best practices. Able to effectively communicate Regulatory requirements to a broad population of constituents. Ability to negotiate and influence others in establishing direction toward improved and enhanced Regulatory compliance. Must possess extensive knowledge of Regulatory Affairs as it applies to the product life cycle as well as other related processes gained from work experience. Ability to maintain responsibility for process or key area of Regulatory Expert level of understanding of Regulatory requirements Strong writing, editing and analytical skills and have experience in developing complex submissions with minimal supervision. Ability to evaluate Regulatory impact of proposed product and / or process changes Travel Requirements: Approximately ≤10% of time Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. **************
    $74k-98k yearly est. 12d ago
  • Program Manager II- R&D

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Plan and manage a large multi-functional product development project and/or several small multifunctional product development projects simultaneously. The position requires strong, enthusiastic leadership skills in a highly technical medical instrument product development environment. The position requires regular interaction with all functions and levels of the organization from R&D scientists and engineers, marketing/sales, quality/regulatory, and operations, through executive management. Directs the program team and project team(s) in a manner to achieve the business results expected. Seeks guidance on unusual and complex problems whose solution exceeds the approved project or program boundaries. Authority of position is that required to carry out assigned duties, except where expressly reserved by the senior management personnel or Werfen Corporate/Division Policy. Responsibilities Key Accountabilities Essential Functions: Program Leadership: Provide technical and team leadership to one or more medium project team(s) or a program team, including planning, scheduling, and technical leadership within the program area. Drive the successful attainment of program/project goals. Project Planning and Scheduling: Responsible for project or program planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates an integrated project plans that meet business objectives and are in compliance with the design control process, while maximizing resource efficiency. Project Execution and Control: Responsible for conducting regular project or program team status meetings and reviews. Ensures deliverables are completed and documented. Identifies the need for and implements changes to the program and project plans that are within approved program and project boundaries. Plan and conduct major program and supporting project and milestone reviews. Agile Project Management: Assume the role of Product Owner for Agile teams that are within the program. Define story requirements and approve deliverables at the Sprint demo. Problem Solving Leadership: Responsible for coordination of project resources to identify the root cause(s) of program and project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. Risk Management Leadership: Responsible for ensuring program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan. Regularly assess and report the status of overall program risk remaining on a program. Design Control: Creates and maintains file to current phase ensuring accuracy. Communication: Responsible for program communication for both within the project team(s) and between the team(s) and executive management. Vendor Management: Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project. Cross Department Collaboration: Responsible to establish communication channels with commercial functions, support team and infrastructure to ensure successful on market change(s) and/or new product introduction. Conflict Resolution: Able to resolve program and project team conflict through the application of good listening skills and negotiating skills. Able to remove oneself from the problem. Fosters a creative, professional climate that will maximize the contributions of the technical staff. Resource Allocation: Ensures that adequate equipment and material resources are available to advance the project(s) and achieve goals and objectives. Works with other program and project managers to make the best use for the business of shared resources. Supervision and Employee Performance: Demonstrated functional management expertise and skills in developing, mentoring and coaching others. Provides direct supervision to Program Managers and Project Managers assigned to the program. Secondary Functions: Project/Program Initiatives: Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures. Budget Managed: Prepares and maintains budgets for the portfolio of programs and projects. Annual budget between $3 million and $8 million Networking/Key Relationships: Works with functional management to conduct performance appraisals and coaching for project core team members. Provide regular supervision for assigned Project Manager(s). To be determined based on department and project needs, to include interactions such as: Coordination of review of documentation with Quality and Regulatory disciplines Communication of product changes with Manufacturing / Operations disciplines Communication of plans and status of projects with Marketing discipline Communication of plans and status with other programs and projects within R&D Qualifications Minimum Knowledge & Experience Required for the Position: BS in STEM field (engineering, chemistry, physics, etc.) At least 8 years of experience, preferably in product development with at least 3 years of successful technical leadership, project coordination, or project management are required. Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable. Certification in project management or program management is preferred. Full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing introduction. Skills & Capabilities: Leadership Skills Analytical Skills Problem-solving, conflict management, listening, managing and measuring work Strong project management skill set and familiarity with project management tools and techniques Team player, self-motivated, perseverance Strong oral and written skills Word, Excel, PowerPoint, Design Control Travel Requirements: Less than 10% of the time.
    $94k-123k yearly est. 12d ago
  • Internal Auditor- Rotational Program

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Exciting opportunity to work in Barcelona, Spain for up to 1 year! This position is to first have an initial onboarding program in Barcelona Headquarters for about 1 year and then can reside in the Boston/Bedford, MA area. During this period, the selected candidate will be appointed as Internal Auditor to receive a solid induction of Werfen and the internal Audit function. The position ensures successful completion of assigned audit engagements, from start to finish, and sometimes pre-planning and wrap up activities. Depending on assigned engagement, reports to one or more member(s) of the Internal Audit senior management team. Ensure a successful completion of assigned audit for all affiliates, from start to finish, including preplanning and wrap up activities. Responsibilities Conduct assigned audit engagements successfully from beginning to end. Identify and communicate issues raised, offering recommended solutions relevant to business and risk. Review the deliverables of contractors assigned to engagements providing guidance and overall review of deliverables. Ensure audit conclusions are based on a complete understanding of the process, circumstances, and risk. Execute audit programs and testing procedures relevant to risk and test objectives. Obtain, write and review the evidences ensuring audit conclusions are well-documented. Manage the Internal Audit Program, which includes assisting in the preparation of a detailed audit plan, making recommendations on the systems and procedures being reviewed, reporting on the findings and recommendations and monitoring manager's action plans and implementation. This will involve travel to all locations. Communicate assigned tasks to engagement team in a manner that is clear and concise ensuring high quality, accurate, and efficient results. Organizes agenda and personal planning along the week of audit fieldwork. Continue to build relations across the company offering a business advice service as and when required. Conduct any reviews ad-hoc. Handle highly confidential information. Perform statistical and financial analyses. Networking/Key relationships Effective communications and relationship with all affiliates stake holders. Qualifications Minimum Knowledge & Experience required for the position: Degree/ diploma obtained, program of study or equivalent and type of experience required. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: ESSENTIAL Excellent oral and written communication skills. Think and act independently. Determine strategies to achieve goals. Prepare comprehensive reports and correspondence. Ability to recognize when learned theoretical concepts should be applied. Solid understanding and ability to apply risk and control concepts. Interact professionally with various levels of hierarchy employees and outside Group Understand, interpret, and apply laws, rules, regulations, policies, procedures, contracts, budgets, and fiscal practices when auditing. Complete audit projects on-time and within budget. Comfortable with change and improving activities. Analyze situations, identify problems, recommend solutions Use of initiative and confident decision making. Time management - priority setting. DESIRABLE Proficiency with Microsoft Office products. SAP basic knowledge. Education: Bachelor's degree - Accounting, Finance, Business Administration, Public Administration, Information Systems or another related field. MBA or Higher Educational Degree in Finance, Accounting desirable. Experience: A minimum of at least 3 years audit experience is required as well as one or more relevant professional certifications (i.e. CPA, CIA, CISA, CFE). Big four accounting firm experience is desirable but not required. Languages: English Castellano/Spanish (preferred) Travel requirements: This position is to first have an initial onboarding program in Barcelona Headquarters for about 1 year and then can reside in the Boston/Bedford, MA area. During this period, the selected candidate will be appointed as Internal Auditor to receive a solid induction of Werfen and the internal Audit function. Normal travel will be up to 50%. Individual Contributor Core Competencies: Managing Work Effectively managing one's time and resources to ensure that work is completed efficiently. Emotional Intelligence Essentials Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others' emotions and behavior; leveraging insights to effectively manage own responses so that one's behavior matches one's values and delivers intended results. Building Partnerships Developing and leveraging relationships within and across work groups, including cross-functional groups, to achieve results. Decision Making Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences. Continuous Improvement Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas and implementing solutions. Continuous Learning Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill on the job and learning through their application.
    $75k-98k yearly est. 12d ago
  • Sales Consultant: Hemostasis Product Line - San Francisco, CA

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Amazing Total Rewards for our Sales Team! Generous Base Salary + Incentive Compensation Company Vehicle with Personal Use Allowance Phone & Internet Reimbursement 8% 401k Match (dollar for dollar!) Comprehensive Health Care Benefits Company paid Life Insurance Flexible Spending Account (FSA) Tuition Reimbursement Talk to your recruiter for full offerings! Position Summary: Within the assigned territory, responsible for direct sales of company products and services. Contributes to the attainment of individual, area and company goals and objectives. Responsibilities The Territory: The San Francisco Hemostasis sales territory covers accounts in Northern California, Hawaii, and Northern Nevada (not including Las Vegas). The ideal home location is somewhere within the Bay area. The ideal candidate for this position will exhibit the following skills and capabilities: • 2-3 years of experience in a hospital lab as a Clinical Laboratory Scientist (CLS) or similar role in a hospital, research, or reference lab. • Science degree preferred • Sales experience is not necessary if you have lab experience or a science degree, but you must have an outgoing, organized, and self- motivated personality. • Willingness to travel Travel requirements: • Up to 50% travel. • This position is based out of a home office but requires daily travel to hospitals and other accounts to visit customers in person. • Anticipated overnight travel away from home of 6-8 days per month. Key Accountabilities: Achieves annual sales objectives as set forth by management. Analyzes existing and anticipated customer requirements and promotes consideration and purchase of company products and services. Initiates and develops contacts with customers, both existing and potential, with focus on new sales opportunities. Prepares and delivers effective product/sales presentations. Maintains all aspects of the Werfen Customer Database and Property Accountability Documents. Achieves and maintains a high level of competency in knowledge and positioning of Werfen products and services. Strives to achieve similar competency regarding competitive systems. Prepares accurate and effective quotations in accordance with existing policy and procdure. Prepares accurate forecasts and other sales reports as required. Prepares an annual territory business plan, with consideration of current corporate and area focus and objectives. Is responsible for complying with all appropriate ISO mandated policies, procedures, work instructions and other duties and responsibilities as assigned by Sales Management. Networking/Key Relationships: This role will interface on a regular basis with: Marketing Sales Operations Client Services Technical Service Information Technology Qualifications Minimum Knowledge & Experience Required for the Position: Bachelor's degree in Business or Scientific discipline or equivalent experience required. Minimum of 3 years prior sales experience (medical and/or capital sales experience preferred), or equivalent business experience required. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Demonstrated proficiency in Microsoft Office Strong customer focus with customer service mindset Demonstrated strong written and verbal communication Goal and action oriented Ability to create working relationships with internal and external stakeholders Ability to work independently with little daily oversight Strong negotiation skills Ability to effectively manage multiple priorities while driving results in a fast paced and deadline driven environment Ability to create and execute sales presentations that focus on value creation Travel Requirements: Up to 50% travel.
    $89k-126k yearly est. 12d ago
  • ME/EE Design and Development of Automated Med Device Co-Op

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Summary: The chosen candidate will be assigned within a multi-discipline team with tasks to assist in the design and development of new automated medical diagnostic instruments. Responsibilities include designing, prototyping and troubleshooting clever solutions towards next generation and on market products. Candidates will gain experience with both Mechanical and Electrical Engineering. On the mechanical side, candidates will be asked to create detailed drawings for their solutions using GD&T (Geometric Dimensioning and Tolerancing) and DFM (Design for Manufacturing) methodologies. Proposed designs will be presented to an engineering team allowing candidates to experience design reviews and grow through design iterations. On the Electrical side, candidates will review schematics, rework PCBs, and gain valuable lab experience. This position will provide the candidate knowledge of a full product development lifecycle of a regulated medical device company. The product lifecycle includes prototyping, manufacturing scale-up, and manufacturing operations, all located in-house at the Bedford, MA facility. Responsibilities The chosen candidate will be exposed to the following software tools: Creo formally known as ProEngineer ANSYS, an engineering simulation software Minitab, a software used for statistical analysis Arduino Programming Windchill, a product lifecycle management tool PADS schematic design tool Microsoft Office including Microsoft Visio The chosen candidate will also be able to further their knowledge in the following topics within Mechanical and Electrical Engineering: Material Selection Microfluidics Automated Assemblies Instrument Design Plastics Design Sheet Metal Design Soldering Lab equipment (DMMs, Oscilloscopes, Power Supplies, etc.) Understanding schematics Circuit design The candidate will be mentored by the Mechanical Engineering Development Team Leader and will be considered an active team member. Additional Perks: IL Team Sports: Tuesday Morning: Soccer, Thursday Morning: Hockey, Friday Afternoon: Flag Football IL Gym Access: Members will have access to IL Gym and locker rooms with showers Subsidized Cafeteria prices: $2-4 Breakfast, $3-5 Lunch Essential Functions: Performs experiments, analyzes and interprets numerical data from experiments. Summarizes findings by computer readouts, statistical summaries, graphs and other methods. Requires confidence in using Microsoft Word and Excel tools. Requires Enthusiasm, motivation, initiative and ability to work within an interactive and energetic workplace. Review process procedures, change orders, equipment specifications, validation plans, and reports. Performs market research on Qualifications Minimum Knowledge & Experience Required for the Position: Currently pursuing B.S. in Engineering, Finance, Business, Marketing with a minimum of 2 college semesters complete. Ability to multitask If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team. **************
    $96k-121k yearly est. 12d ago
  • Senior Manufacturing Engineer II

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary Responsible for leading the process engineering and production support of a product or product line. Provides technical leadership and support for continuous improvement team efforts focused on process improvement and optimization. Provides engineering leadership for the design, documentation and implementation of assembly methods, test methods, equipment operation, including specification and optimization. Responsibilities Key Accountabilities: Responsible for the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions Responsible for delivering long-term cross functional impactful projects on time and on budget May be required to act as Product Champion for a specific product or product line with the following leadership responsibilities The focal point in operations for the products which they have responsibility for. Leads the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions. Leads the process engineering and production support activities required for the manufacture of a product line. Provides technical support and leadership for continuous improvement team efforts focused on process improvement and improvements to product manufacturability. Provides technical leadership and hands-on engineering support, including specification and implementation of assembly/test methods and process optimization. Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposals Responsible for establishing the Manufacturing Quality Plan (MQP) for a product or product line including process flow, production floor layout, equipment, line balancing, etc. Writes process procedures, change orders, equipment specifications, validation plans, and reports Performs research on technology, equipment, and tooling to improve process quality, yield, or cost; Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis Performs engineering design of test equipment, assembly equipment, fixtures, and tools; Performs IQ/OQ/PQ validation activities Participates in the introduction of new products into manufacturing; Collaborate with R&D and suppliers to improve product robustness and manufacturability both pre- and post-release Supervises (as assigned) personnel in classifications below that of Senior Mfg. Engineer May lead or participate in Lean Six Sigma projects of significant scope and complexity Budget Managed (if applicable) N/A Internal Networking/Key Relationships To be determined based on department needs Skills & Capabilities: Functional/technical skills Qualifications Min Knowledge & Experience required for the position: B.S. in Engineering and a minimum of 12 years of experience or an M.S. Degree and at least 8 years of experience Experience in technical support for the manufacturing of instrumentation and/or disposables preferred Experience in Lean and Six Sigma problem solving methodologies preferred International Mobility: Required: no Travel Requirements: If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. **************
    $84k-106k yearly est. 12d ago
  • Process Engineer II- R&D

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    Using procedures standard to the company, carries out assignments associated with research, design, or development, and manufactures specific parts, components, or minor phases of a project. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Under the general direction of senior Engineering personnel, with moderate latitude for self-direction, operate in one or more areas of responsibility within a specific section or department. Responsibilities Key Accountabilities: Performs varied engineering assignments under minimum of direct supervision and technical guidance. Technical responsibilities directed to engineering assignments which substantially add to the program. Designs and develops moderately complex parts, components, and/or circuits. Provides technical direction to support personnel as directed by engineering supervisor. Accomplishes independent designs, analyses, and interpretations of engineering data. May test materials for adherence to technical specifications. Prepares specifications for developed parts, components, and/or circuits. Maintains a good engineering notebook. Provides limited technical guidance to other engineers and supervision to technicians assigned to projects. Performs other duties as requested Budget managed (if applicable): N/A Internal Networking/Key relationships. Assists senior engineering personnel in solution of complex problems. Works closely with other engineers and support departments. TBD based on departmental needs Skills & Capabilities: Problem Solving Detail Oriented Time Managemen Teamwork Priority Setting Qualifications Min Knowledge & Experience required for the position: B.S. in Engineering and a minimum of 2 years experience related to the areas given above or suitable equivalent combination of education and experience. International Mobility: Required: no Travel requirements:
    $82k-106k yearly est. 12d ago
  • IT Solutions Implementation Engineer

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    This position is responsible for the successful implementation of Werfen's data management solution(s) for new and existing Werfen customers in collaboration with the IT Solutions Architect. This includes, but is not limited to, completion of all required post sale technical implementation activities, ensuring the product application/solution functions to specifications. Ensures customer satisfaction during the installation, validation, integration and go-live processes. Responsibilities Key Accountabilities Essential Functions: Collaborates with IT Solutions Architects, and/or stakeholders to translate customers' functional and business requirements to ensure functional specifications are converted into flexible, scalable, and maintainable solution designs Designs, gains agreement, and communicates professional project plans for customer implementations, utilizing IL's appropriate products and solutions Manages expectations, identifies risks, and formulates plans to minimize impacts to the project. Coordinates activities to ensure project progresses on schedule while meeting all other specified project performance parameters. Actively participates in and conducts pre-implementation, implementation and post-project review meetings for customers and internal stakeholders. Performs troubleshooting during the implementation to ensure IT solutions are fully functional and utilized as planned. Understands gaps, proposes mitigation plans, and escalates as required to ensure complete customer satisfaction. Ensures designs are in compliance with all regulatory policies, procedures and records Secondary Functions: Assess new and upgraded software and related hardware to determine technical implementation plan for commercial introduction Other duties and responsibilities as assigned Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs, to include interactions such as: Commercial Operations Organization | Implementation and Project Team Strategic Business Unit | Marketing | Service On-Market Engineering Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Strong interpersonal and communication skills, both verbal and written Ability to author documents, diagrams, and presentations Ability to communicate effectively, influencing customers and internal teams Ability to gather, analyze and articulate high-level business capabilities and requirements Ability to work under own initiative /self-motivated Ability to work in a regulated environment Demonstrated ability to solve complex technical challenges Adaptability; ability to manage workload and competing priorities Highly collaborative; ability to work cross-functionally, with multi-disciplined teams Qualifications Minimum Knowledge & Experience Required for the Position: Education: Bachelor's degree in Information Technology, Computer Science or Engineering required or equivalent experience in lieu of a degree will be considered. Experience: Minimum of five years' working in an IT support role. Focus on IT applications preferred. Minimum of five years' experience with Healthcare IT requirements required: Interface Engines, IT Security for healthcare environments, Connectivity, Databases ADT/POCT Devices required. Project Management experience desirable Additional Skills/Knowledge: Advanced Knowledge of clinical/healthcare IT environments Advanced Knowledge of cybersecurity, keeps current within industry trends and mitigation Advanced Knowledge of IL IT Solutions portfolio applications to determine functionality meets customer needs Language: Fluency in English required International Mobility: Required: No Travel Requirements: Up to 30% travel
    $80k-104k yearly est. 12d ago
  • Clinical Educator I

    Steris Plc 4.5company rating

    Boston, MA Job

    Workplace Type: Onsite At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. ****How You Will Make a Difference**** No two people learn the same way, at the same pace. That's where you come in. As a Clinical Educator, you will not only be the face of orientation and training for your facility and team, but you will also use your experience and expertise to develop each individual's skills and abilities throughout their time in the Sterile Processing Department. ****What You Will Do**** * Design and implement training plans based on the priorities of your facility and staff members * Lead multi-week training programs for all new Sterile Processing employees at your facility * Document and review training efforts for compliance with industry standards and regulations * Identify employee knowledge gaps at your assigned facility and create an ongoing development plan for all members of the Sterile Processing team * Build continuing education programs with a focus on new products and procedures ****What You Need to Be Successful**** * High school diploma or GED, Bachelor's degree preferred * 3+ years' experience in Sterile Processing * 3+ years' experience in training * Sterile processing certification required ****What We're Offering You in Return**** Employees are what makes a company great, so we believe it's important to take care of them just like we take care of our Customers and their patients. In addition to being a global organization and industry leader with ample room to grow your career, we also offer benefits including Medical/Vision/Dental, Paid Time Off, and a 401(k) with company match. We all hope to have a mentor who instills in us a love and enthusiasm for what we do. As a Clinical Educator, you can be that person for our current and future employees. If you're looking for the chance to further your career with a company that offers career development and leadership opportunities, click the apply button below. Let's create a healthier and safer world, together. STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries. If you need assistance completing the application process, please call 1 . This contact information is for accommodation inquiries only and cannot be used to check application status. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity. The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours. Job Category: Clinical Support, Operations & Education Location: Boston, MA, US, 02115
    $71k-85k yearly est. 13d ago
  • Spring 2025 ACDx Electrical Engineering Co-Op

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    The purpose of the cooperative experience is to provide a semester long hands-on experience. Werfen hires students with leadership potential and proven academic success. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities. Responsibilities Key Accountabilities To perform entry level work of a routine nature requiring application of standard techniques, procedures and criteria in carrying out a sequence of related tasks. Responsible for process and production support of a product or product line. Provides support for continuous improvement team efforts focused on process improvement and optimization. Provides design, procedures and implementation of assembly methods, test methods, equipment operation, including specification and optimization. Ability to lead and influence at various levels and functions of the organization through strong interpersonal and communication (oral and written) skills. Competency in conducting desk research and competitive intelligence, distilling down vast amounts of data into concise summaries focused on the key strategic & financial implications to IL Essential Functions: Performs experiments, analyzes and interprets numerical data from experiments. Summarizes findings by computer readouts, statistical summaries, graphs and other methods. Requires confidence in using Microsoft Word and Excel tools. Requires Enthusiasm, motivation, initiative and ability to work within an interactive and energetic workplace. Review process procedures, change orders, equipment specifications, validation plans, and reports. Performs market research on Qualifications Minimum Knowledge & Experience Required for the Position: Currently pursuing B.S. in Engineering, Finance, Business, Marketing with a minimum of 2 college semesters complete. Ability to multitask
    $80k-103k yearly est. 12d ago
  • Paralegal

    Instrumentation Laboratory Company 4.8company rating

    Instrumentation Laboratory Company Job In Bedford, MA

    The Paralegal is responsible for supporting the commercial, clinical, and corporate activities of the Hemostasis and Acute Care Diagnostics business unit of Werfen. Responsibilities include but are not limited to contract review, negotiation, and analysis in alignment with corporate strategy and goals. The role will report to the Assistant General Counsel and will collaborate closely with other key internal business partners, external parties, and other members of the Legal department. Responsibilities Key Accountabilities Support the Legal team with respect to contract adminstration including reviewing, drafting, redlining, and negotiating terms and conditions in various agreements, such as confidentiality, consulting, service, supply, sponsorship, and clinical and research agreements Assist with reviewing, drafting and filing documentation for corporate governance matters, including board and stockholders consents/minutes, secretary and officer certificates, letters of authorization, and powers of attorney Ensure agreements and other related documents are executed and maintained properly per Werfen practices, policies and procedures Identify opportunities and lead or support project initiatives for process improvement that contribute to the efficiency and effectiveness of the overall contracting process Exhibit and uphold the Werfen values of honesty, humility, respect, trustworthiness, credibility, openness, reliability, listening to others, and building trustworthy relationships Perform other duties as requested by the Legal department Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key Relationships Fosters an open and collaborative working relationship with internal stakeholders across the organization. Qualifications Minimum Knowledge & Experience for the position: Bachelor's Degree or paralegal certification with 3+ years of professional experience, ideally in the medical device, diagnostics, or healthcare industry, required. Registered notary public or willingness to obtain a notary certification, preferred. Experience in management of corporate books and records, preferred. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Able to read and understand terms and conditions and apply a practical, business-minded approach to contract review and negotiation Capable of coordinating and prioritizing multiple tasks/projects while maintaining accuracy in a fast-paced environment Capacity to interact professionally with internal stakeholders of varying seniority levels Ability to work independently with minimal oversight and in group settings Possess a positive attitude and high emotional intelligence and business acumen Exhibits sound judgment and strong analytical skills Excellent written and verbal communication skills Effective organizational and administrative skills, including keen attention to detail Strong computer skills with advanced skills with Microsoft Word, Excel and PowerPoint Prior experience engaging in internal operations projects (e.g., template development, document management) preferred Travel Requirements: Ability to travel domestically and internationally upon request if needed (no more than 5% of the time).
    $52k-68k yearly est. 12d ago

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