Haemonetics
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• Function as TEG (Thromboelastographic) product line Clinical Advisor/Clinical Specialist • Support ongoing account management sales process through clinical education and ongoing case support • Grow sales in existing accounts and support new accounts with a growth mindset • Territory management for existing TEG customer base • Increase product usage at existing accounts and expand customer base through clinical education • Train new and existing customers on all product and clinical aspects of TEG line • Provide clinical expertise to help ensure that our TEG product line reaches standard of care levels • Help drive and expand existing business to include broadening application of our TEG within the account
Role Description Ensure compliance with applicable regulations, standards, corporate policies, and procedures related to design controls, product development, and engineering change management within the quality system. - Serve as the Quality representative on cross-functional teams for new product development, product design changes, and product line portfolio initiatives. - Develop, manage, and execute project-specific Quality Plans. - Lead or contribute to the translation of Voice-of-Customer (VoC) feedback into measurable engineering requirements. - Support the drafting, review, and approval of engineering requirements and specifications in compliance with standard operating procedures. - Lead cross-functional risk management efforts, including development and maintenance of risk documentation such as: - Hazard Analyses - Risk Management Plans and Reports - Use/Design/Process FMEAs - Fault Tree Analyses (FTA) - Support or lead the development and review of design verification, validation, and process validation plans, protocols, and reports. - Lead the identification and documentation of critical-to-quality (CTQ) characteristics and specifications. - Ensure full traceability between user needs, system requirements, and verification/validation activities. - Perform or support Measurement Systems Analyses (MSA), including the development and validation of test methods. - Define statistical sampling plans and test methodologies for verification and validation activities. - Contribute to multiple product portfolios; provide subject-matter expertise across various product lines as needed. - Maintain and ensure completeness of the Design History File (DHF) and Device Master Record (DMR). - Analyze product failure data and provide actionable insights and recommendations to development teams. - Mentor, coach, and/or train junior quality engineering staff. - Administer and support Quality System elements including: - Design Controls - CAPA - Non-Conformance - Complaints - Deviations - Document Control - Labeling - Lead or participate in quality system improvement initiatives, including updates to policies, procedures, work instructions, and training materials. - Ensure inspection and audit readiness; support internal and external audits by regulatory bodies and customers. - Lead or contribute to structured problem-solving and continuous improvement projects. Qualifications - Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related field (or foreign degree equivalent) and at least 5 years of experience with Design Quality Engineering within a medical device or other regulated environment. - Employer will also accept a Master’s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related field (or foreign degree equivalent) and 2 years of experience with Design Quality Engineering within a medical device or other regulated environment. Requirements - At least 2 years of experience with medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485). - At least 2 years of experience managing cross-functional projects. - At least 2 years of experience in technical writing, including authoring requirements and specifications. - At least 2 years of experience with Voice-of-Customer development and translation into engineering requirements. - At least 2 years of experience performing risk analysis, including FMEA and FTA. - At least 2 years of experience with measurement systems, applied statistics, reliability testing, and continuous improvement methodologies. - At least 2 years of experience mentoring or training junior team members. - At least 2 years of experience working with medical products, including blood collection systems, apheresis devices, or hemostasis management software. Benefits - Competitive salary: $140,587 – $150,000/year. - 401(k) with up to a 6% employer match and no vesting period. - Employee stock purchase plan. - Flexible time off for salaried employees. - Accrual of three to five weeks’ vacation annually (based on tenure) for hourly employees. - Accrual of up to 64 hours (annually) of paid sick time. - Paid and/or floating holidays. - Parental leave. - Short- and long-term disability insurance. - Tuition reimbursement. - Health and welfare benefits.
Role Description The Regional Clinical Specialist position will take a lead role in the training of physicians, nurses, and technicians on the proper use and advantages of Haemonetics Medical products in Cardiac Cath Labs, Interventional Radiology, and Vascular Surgery suites. - Assist in product launches in their region and support busier teams when needed. - Assist in clinical trials not only in their region but around the country when needed. - Aid in the training of new hires and continued development of the region's team. - Contribute to achieving projected sales goals, company objectives, and increasing sales revenue. Essential Duties - Support the TM in the organization and analysis of evaluation/trial data. - Identify issues related to the usage of Haemonetics products and share those issues with the Regional Sales Director and appropriate TM. - Provide additional in-service training to the impacted clinical staff if issues stem from incorrect or inappropriate usage of the device. - Facilitate the clinical training and on-boarding of new field personnel. - Provide clinical expertise for Structural Heart implanting centers. - Assist in education and training activities with physicians, hospital support staff, and Haemonetics personnel. - Stay abreast of and communicate clinical data regarding Haemonetics portfolio of products. - Provide support on questions regarding device suitability and comprehensive technical support. - Develop and maintain comprehensive clinical and technical product knowledge. - Oversee local education and training activities. - Identify, establish, and maintain productive working relationships with key decision makers and customers. - Act as a spokesperson related to procedural expertise and updated best practices within assigned region. - Develop therapy and device operational knowledge to support procedural excellence. - Serve as the region expert for Interventional Technology procedures. - Present Haemonetics clinical papers and overall value proposition while complying with regulations. - Support the monitoring of product inventory levels. Qualifications - BA/BS or equivalent required. - Health science and appropriate registrations or certifications (RN, RCIS, RCSA, RVMS, etc.) - Required. - Minimum of 5+ years of directly related experience in the medical device industry. - Strong clinical orientation, experience with products for use in interventional and structural cardiology. - Extensive experience in the cardiac cath lab environment or as a scrub nurse/tech for Structural Heart procedures. - Minimum experience of 3+ years of structural heart experience in a commercial role - preferred. - Minimum of 3+ years: Medical device experience with 3+ years in structural heart in commercial role - Required. Requirements - Excellent interpersonal skills and strong clinical orientation. - Ability to influence a variety of clinician, nurse, and lab tech personality types. - Previous industry experience with structural heart clinical specialist role. - Ability to persuasively communicate and tailor the Interventional Technology Value Proposition. - Analytical with financial acumen. - Ability to maintain a good working relationship while dealing with sensitive matters. - Excellent verbal and written communication skills. - Attention to detail to maintain records and process reports. - Thorough knowledge of the medical device market, products, and territory's customer base. - Emotional intelligence to manage their schedule effectively. - Previous industry experience in the Structural Heart space with preference to TAVR. - Previous experience providing clinical education and training to staff members is preferred. - Values teamwork and collaboration internally and externally with customers. Benefits - Competitive suite of benefits including a 401(k) with up to a 6% employer match and no vesting period. - Employee stock purchase plan. - Flexible time off for salaried employees. - Accrual of three to five weeks’ vacation annually for hourly employees. - Accrual of up to 64 hours (annually) of paid sick time. - Paid and/or floating holidays. - Parental leave. - Short- and long-term disability insurance. - Tuition reimbursement. - Health and welfare benefits.
• You are responsible for installation, maintenance, servicing, and troubleshooting of medical technology devices at customer sites • You maintain customer relationships, identify sales opportunities and report them to the responsible Sales Manager • You ensure minimal downtime of all machines in your territory through fast and reliable fault diagnosis • You perform maintenance on Haemonetics devices in hospitals, blood donation, and plasma centers • You represent our company in the best possible way to customers • In close cooperation with Sales and Application teams, you sustainably ensure customer satisfaction and help grow the business.
• Effectively sells capital equipment, disposables, software, and service within the Hemostasis Management and Cell Salvage portfolios • Accountable for overall territory management, achievement of sales goals, and account management • Develop and execute comprehensive territory plans to increase revenue • Partner with cross-functional counterparts to effectively deliver our technologies • Maintain existing business and ensure accounts are contractually compliant • Resolve customer concerns through accurate investigations • Keep up-to-date account data within CRM • Travel up to 75% depending on territory geography and need • Educate customers on products and industry trends • Conduct superior sales presentations and product evaluations • Function as Project Manager post-sale, managing product implementation
• Own the deployment and maintenance of AWS services and applications and on-premise infrastructure for medical software solutions. • Develop infrastructure automation using Terraform, AWS CloudFormation, and Ansible. • Help troubleshoot networking and connectivity issues in hybrid environments (AWS & on-prem). • Work with senior R&D engineers to enhance security, scalability, and compliance. • Support on-premise software installations using automation tools like Ansible, PowerShell, or Python. • Assist in automating deployments, rollbacks, and software updates. • Learn and apply security best practices for AWS and on-prem environments. • Assist in ensuring compliance with HIPAA, FDA, ISO 13485, and IEC 62304. • Help implement monitoring and logging solutions for security and performance. • Support monitoring of infrastructure and applications using CloudWatch and Datadog. • Work with senior R&D engineers to resolve performance bottlenecks and reliability issues. • Assist in incident response and system health checks.
• Manage companywide indirect spend and the related supply base in support of plant, business unit, and corporate goals (Service, Quality, Cost, Working Capital, etc.) • Build business relationships and work with key business partners/leadership to gain a solid understanding of strategic direction, supply requirements, business objectives, and priorities to develop global or regional category-specific supply strategies • Negotiate contracts on behalf of the company with Year-Over-Year (YOY) productivity expectations • Lead supplier selection processes in alignment with business partners and negotiate contracts up to final authorization • Maintain and review supplier performance to ensure conformance to supplier management goals (cost, quality, delivery) • Ensure timely resolution of all disputes • Develop and lead sourcing strategies for categories, and deliver effective Requests for Proposals (RFP), as necessary • Provide guidance to R&D (technical and commercial) and Engineering teams regarding new industry trends and provide market intelligence • Lead the risk management and supply continuity programs for the category • Manage contracts and suppliers through supplier scorecards, periodic business reviews; active monitoring of supplier performance and risk, measuring contract compliance and other key metrics to ensure targets are being met and value is being delivered to the business under the supply agreements • Perform category management activities and contract life-cycle management to include reviewing/renewing expiring contracts, updating pricing and commercial terms • Proactively address marketplace changes managing any known or potential business impacts • Provide commodity guidance and build an annual budgeting plan for the plastics and molding category
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details The Clinical Specialist will work with the sales management within a defined geographic area to meet existing and potential customers (e.g., physicians, physician office groups at hospitals) to identify their clinical needs, goals, and constraints related to patient care and to discuss and demonstrate how the company’s interventional products can help them achieve their goals and meet patient/client needs. By providing case coverage, the Clinical Specialist will contribute to achieving projected sales goals, Company objectives, and increasing sales revenue. Essential Duties - Collaborates with sales management to provide good case coverage and clinical outcomes for patients. - Serves as the primary clinical resource for clinical support in the areas of coverage troubleshooting and in-service education for company products. - Informs the customer on the latest product, therapy and technology developments in the industry by actively engaging in procedural and technical discussion. - Demonstrates the ability to link clinical data to key messaging. - Meets with existing and potential customers to identify their clinical needs, goals and constraints related to patient care and provide creative and feasible solutions using company products. - Collaborates and communicates account and other requested information to sales team on a daily basis. - Share insights on competitive products or on account issues, opportunities with appropriate colleague. Educates the customer on the merits and proper clinical usage of company products. - Oversee local education and training activities including coordination and set up of programs, procedural troubleshooting, and coordination and facilitation of staff education. - Identify, establish, and maintain productive working relationships with key decision makers, customers and their staff, and administrative staff, etc. - Support monitoring of product inventory levels. - Other Duties as assigned Supervisory Responsibilities: None Qualifications Education Required: Bachelors of Arts or Science Medical training (RT, RCIS, Surgical tech, RN, NP, or first assistant) preferred Years of Experience 5+ Directly related experience of the medical device industry. Strong clinical orientation, experience with products for use in interventional cardiology, electrophysiology, vascular or cardiac surgery. Training/Certifications None Skills • Excellent interpersonal skills and strong clinical orientation with the ability to influence a variety of clinician, nurse, and lab tech personality types. • Ability to persuasively communicate and tailor the Vascular Closure Value Proposition. • Analytical with financial acumen (understanding of how our products performance and data impacts a health system's bottom line). • Ability to maintain a good working relationship while dealing with sensitive and confidential matters. • Excellent verbal and written communication skills. • Attention to detail to maintain records and process reports. • A thorough knowledge of the medical device market, products, and territory's customer base. • Emotional intelligence to manage their schedule effectively and efficiently. • Previous industry experience preferably in the Cardiovascular space calling on Interventional Cardiologists, Vascular • Surgeons, Interventional Radiologists, administrators, and clinical staff members. • Previous experience with vessel closure is preferred. • Previous experience providing clinical education and training to staff members is preferred. • Values Teamwork and collaboration internally and externally with customers. • Knowledge of MS office systems. Physical Demands Sitting; remaining in a seated position. - Occasional Standing; walking; reaching with hands and arms; and stooping, kneeling, crouching, or crawling. - Constant Lifting/moving up to 10 pounds. - Constant Fine manipulation; picking, pinching, or otherwise working primarily with fingers rather than the whole hand or arm as in gross manipulation. - Constant Keyboarding; entering text or data into a computer or other machine by means of a keyboard. - Frequent Exposure to moving mechanical parts, vibration and/or moderate noise levels. - Constant Exposure to hazardous chemicals or other materials. Frequent Exposure to blood. - Frequent Travel Expectations: Regular Domestic: 25-50% EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email AskHR@Haemonetics.com. The base salary range for this role is: $86,800.00-$161,200.00/Annual
• Function as Clinical Sales Specialist to the customer and effectively drive utilization and expansion of TEG & Cell Saver products line at existing customer sites within defined territory • Support ongoing account management sales process through clinical education and ongoing case support in all existing and potential areas of operation and clinical utilization within the customer site • Territory management for existing customer base • Increase product usage at existing accounts and expand customer base through clinical education of new users and generate revenue growth • Ensure customers are able to independently, safely and efficiently operate Haemonetics equipment, software, and related disposables for the assigned products line • Train new and existing customers on all product and clinical aspects of the assigned products line • Provide summary of training sessions and ensure follow up as needed through onsite support in the many areas of operation and application such as lab, critical care, and OR • Provide clinical expertise to help ensure that our products line reaches standard of care levels within the account • Help drive and expand existing business to include broadening application of our products within the account • Provide dedicated onsite support for new customers “going live” with the technology or additional assays inclusive of all affected shifts and areas of use case support and training inclusive of after-hours support • Resolve technical, operational, and clinical customer concerns through accurate and timely investigation and partner with cross-functional team members to develop solutions • Increase professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks and participating in professional societies and conferences • Provide history by maintaining records within CRM tool on area of responsibility and customers in that area • Support VAD/ECMO customers, Trauma, CV, High Risk Obstetrics, Liver transplant, Vascular, and all Critical Care clinicians in their use of TEG • Assist customers in tailoring their products training materials and needs • Understand competition and competitive landscape in existing territory, and convert to TEG Haemonetics business in existing accounts • Work closely with Territory Sales Manager in overlapping market to target key accounts for expansion and forecast revenue increase during quarterly business planning and monthly cadence calls with management • Provide tradeshow support, both regionally and nationally • Drive demand for device and software upgrades as well as add on devices • Work closely with Territory Sales Manager and Implementation team during laboratory installation, validation, and verification process including assistance with training, competency, SOP and IQCP development, normal donor sourcing, logistics support for TEG program, and ordering/interfacing needs • Prospect and develop multi-level relationships (including C-level) within defined territory • Participate in product development market needs and/or quality investigative needs and launches while providing feedback to sales, marketing and R&D
• Function as Territory Sales Manager to hospital customers and prospects within the assigned geography • Effectively sell equipment, disposables, software, and service within our Cell Saver and Haemostasis product lines through a strategic sales process • Influence standard of care of our technologies within multidisciplinary specialities • Accountable for overall territory management, achievement of sales goals, profitability and account management within the assigned product lines • Develop and execute comprehensive territory plans by account to increase revenue and secure new business • Partner with cross-functional counterparts to effectively deliver and drive the adoption of our technologies • Maintain existing business including ensuring accounts remain compliant and incremental business is achieved
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