Rapid Micro Biosystems jobs - 25 jobs

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit. Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and have the ability to make a profound impact on our business. The Sales Enablement Manager will develop and implement sales enablement programs that equip our customer-facing teams with the knowledge, tools, and content needed to effectively position, differentiate, and sell our complex scientific solutions. This role requires a blend of scientific acumen, marketing strategy, and sales effectiveness expertise to shorten sales cycles, increase win rates, and accelerate the ramp time for new hires. Key Responsibilities Strategy and planning: Develop and execute a comprehensive sales enablement strategy aligned with overall business and revenue goals. Onboarding and training: Design and deliver comprehensive onboarding programs for new sales hires, focusing on product knowledge, scientific applications, and competitive positioning. Content and messaging: Partner with product marketing and scientific teams to create and manage a repository of high-impact sales content, including playbooks, battle cards, case studies, and presentations. Field communications: Ensure consistent and timely communication of market updates, new product information, and competitive intelligence to the sales team. Cross-functional alignment: Act as a key liaison between sales, marketing, and product management to ensure all teams are aligned on go-to-market strategies, messaging, and goals. Sales process optimization: Partner with Sales Operations to implement and manage sales tools (e.g., CRM, sales enablement platforms) to streamline the sales process, improve efficiency, and enhance the seller and customer experience. Performance analysis: Track and analyze key sales metrics and performance data to measure the effectiveness and ROI of enablement initiatives. Use these insights to identify skill gaps and refine programs. Coaching: Provide ongoing coaching and development to the sales team to reinforce training and improve selling skills. Compliance: Ensure all sales content and processes adhere to the strict regulatory requirements of the life sciences and healthcare industries. Qualifications Education: Bachelor's degree in Life Sciences, Business, Marketing, or a related field. An advanced degree is a plus. Experience: 5+ years of experience in sales enablement, marketing, or a related commercial role within the life sciences, biotech, or medical device industry. Technical expertise: Strong understanding of the life science and biotechnology market, including key trends, customer personas, and scientific applications. Analytical skills: Proven ability to analyze sales data, identify performance drivers, and measure the effectiveness of programs. Communication: Exceptional communication, presentation, and interpersonal skills, with the ability to convey complex scientific concepts simply and compellingly. Sales knowledge: Experience working with CRM platforms (e.g., Salesforce) and familiarity with sales methodologies. Project management: Strong project management skills with the ability to manage multiple initiatives simultaneously in a fast-paced environment. Collaborative spirit: Proven track record of successful cross-functional collaboration with marketing, sales leadership, and product teams. Rapid Micro Biosystems is proud to offer a competitive total compensation package designed to attract, inspire and retain the best talent in our industry. In addition to base pay, our full-time regular employees are eligible for an attractive benefits package, cash incentive opportunities, and an equity grant. The base annual salary hiring range for this position is $110,000 - $148,000 Starting salaries are determined based on skills, experience, budget and other job-related factors. More information about our total compensation package will be shared with candidates during the recruitment process. ABOUT RAPID MICRO BIOSYSTEMS:Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company's Growth Direct™-the first and only growth-based system to automate rapid compendial QC Micro testing-ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation. Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes. Rapid Micro Biosystems is headquartered in Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore. Equal Opportunity:Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.

Under direction of the department manager, provides technical assistance to customers and Werfen field personnel within a product line responsibility. Troubleshoots, over the phone, answers a broad range of technical questions regarding instrument performance, instrument capabilities, QC concerns and other product concerns as required. Assists in the training and direction of new personnel within the department. Responsibilities Key Accountabilities: Provides first line contact on phone calls for instrument assistance (hardware/software/methodology) when possible, resolves issue with customer during first contact. Obtains and records necessary information from customer to provide adequate and useful record of contact and problem encountered. Troubleshoots instrument problems with customer or Werfen field personnel, ascertaining customer's willingness and ability to perform necessary tasks. When required, obtains necessary information and dispatch service request to appropriate Field Service Representative. Assumes responsibility for call until it is transferred to the field. Assists in training and guidance of new department personnel. Enhances personal knowledge of Werfen products and other disciplines to increase ability to provide rapid, effective support. Acute Care Diagnostics product line specialists participate in on-call rotation after hours/weekends and holidays. Hemostasis product line specialists assist as needed/required with covering off-shift hours/weekends/holidays and/or on-call responsibility. Represents the department within Werfen as required to provide proper information for problem resolution. Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs Skills & Capabilities: Must have good 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 I reports. Demonstrated proficiency in MS Windows operating systems versions. Proficient skills in typing, Lotus Notes, Excel, Word and other job critical applications Qualifications Minimum Knowledge & Experience Required for the Position: Bachelor's Degree in Medical Technology, Biomedical Engineering or a related field or equivalent experience Minimum 3 years' experience in a clinical setting Previous customer support experience is desirable International Mobility Required: No Travel Requirements: The annual base salary range for this role is currently $80,000 range to $95,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

As a QA Laboratory Technologist III, you will evaluate materials and products to ensure they meet our high quality standards. You will work within a team to perform a broad range of laboratory work requiring application of professional judgment, perform specialized studies and/or specific assignments within the Product Quality Laboratory. Responsibilities include validations, reliability testing, functional testing, proficiency survey testing and general housekeeping. General laboratory tasks include: inventory management, data analysis, calibration and maintenance, quality control and laboratory testing. Responsibilities Key Accountabilities Responsible for the execution of: Reliability Testing, GEM Functional Testing, GEM Prescreen Testing, Value Assignment for Werfen products, Proficiency Testing, Validation Activities, and etc. Ability to interpret clinical proficiency survey results of difficult complexity. Performs calibration coordination: maintain accurate calibration records in SAP, lead potential out-of-tolerance equipment investigations, train staff, and execution of calibration and maintenance for laboratory equipment. Maintains inventory of laboratory supplies, reagents, and other consumables. Monitors proper storage conditions and expiration dates are maintained. Train other QA Laboratorians and Medical Technologists on protocols, techniques, and project specific studies. Participate in cross-functional meetings to present data, may involve slide creation, presentations, and maintain detailed and accurate records. Responsible for Proficiency Survey scheduling including meetings and shipments. Manage data for survey results, calibrations, Reliability and Functional testings and other studies. Other duties as directed by the Manager/designee. Networking/ Key relationships Work with various functional groups throughout the organization including other Werfen sites. Qualifications Minimum Knowledge & Experience required for the position: Bachelor's Degree in science related field or Medical Technology. Medical Technologist Preferred. Five years or 2 years (with a Master's) of clinical laboratory experience. Lean and Six Sigma certification is a plus. Skills & Capabilities: Expert knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practices (GWP), and Product Quality Escalation. Knowledge of equipment calibration, maintenance processes, and techniques. Excellent oral and written communications, problem solving, statistical knowledge. Proficient in MS office applications particularly Excel, Work and PP. Minitab and Power BI is a plus. Ability to work safely and efficiently in a busy biohazardous laboratory environment. Reliable and dependable. Ability to lift and move materials per current OSHA standards. Travel requirements: N/A

The Intellectual Property (IP) Counsel is responsible for providing high quality IP service to the entire Werfen organization. The position reports directly to the Chief IP Counsel. The IP counsel is responsible for strategically establishing patent portfolios in different business areas, perform freedom-to-operate, assist with IP due diligence, support internal clients and manage outside counsel, and work closely with both the business and the Chief IP Counsel on a daily basis. Responsibilities Key Accountabilities Initiate, improve, and implement IP strategies and processes across Werfen technology centers to optimize IP asset procurement Identify strengths and weaknesses and set priority to selected technical areas for IP procurement Update databases and provide IP statistics information to business Continue to learn the ever changing IP laws and practices in major jurisdictions and apply such knowledge effectively in daily work Perform freedom-to-operate studies and provide high quality work products to business Effectively, efficiently, and independently manage outside counsel to ensure high quality prosecution work product within a reasonable budget Perform trade secret survey and strategize and implement trade secret policies adapted to local laws within Werfen entities Assist with trademark portfolio management Assist with IP related agreements Support software licensing matters and other day-to-day IP related matters, including responding to client inquries or perform other assigned tasks as they arise Support IP due diligence Performs other duties and responsibilities as assigned. Networking/Key relationships Establish and maintain good working relationships with marketing, R&D, and other stakeholders within the business. Qualifications Minimum Knowledge & Experience required for the position: Bachelors degree in science or engineering, preferably in biological sciences, required. JD from an accredited U.A. law school and membership in good standing of state bar re-quired. Admission to practice before the U.S. Patent & Trademark Office required Minimum of 5 years of relevant experience gained in a law firm required. In-house experi-ence is a plus but is not required. Solidly trained in patent drafting and prosecution, and currently able to independently draft and prosecute without senior attorney's supervision. Well-versed in patent law in major jurisdictions in software, hardware, and diagnostic as-says. Substantial freedom-to-operate (FTO) experiences, including searches, evaluations, and work product generation. Preferred training or experience relevant to life sciences, chemical analysis, or materials characterization and strong technological aptitude and inclination to learn and work with a range of technologies. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Proven ability to establish a high degree of credibility, respect and trust at all levels including with technologists, scientists, managers and executives. Strong professional and personal communication skills, capable of dealing with a wide range of people. Be accountable for the responsabilities taken or work assigned. Effective planning and organizing skills to prioritize key areas of responsibility, tasks and projects. Ability to prioritize and manage multiple projects. Strong team player who is both committed and flexible. Combination of in-depth legal knowledge and commercial awareness of the business issues facing the organization and the ability to deal with problems in a practical manner. The successful candidate must also exhibit the highest integrity, excellent judgment, and the ability to proactively recognize and effectively communicate legal issues to patent, legal, and senior management Be energized by challenging and interesting legal work, technical and scientific matters, and novel business problems. Be keenly interested in and curious about technology and eager to work closely with technology development professionals. Be able to work cross-functionally to develop knowledge to enhance support of business needs. Have excellent drafting and very clear communication skills. Must be able to multitask and prioritize in a dynamic work environment. Must be able to independently lead projects and complete tasks timely with high quality work products and with minimum supervision. Must be professional, thoughtful, respectful, flexible, responsive, and accountable. Must be willing to work on not only high-risk matters but also daily matters including looking up patent status or generating statistics or responding to client inquiries on vari-ous matters. Must be willing to adapt to the Werfen business environment, learn about business per-spectives, and practice within. Must be able to think strategically but also work on details meticulously. Must be able to initiate projects as needed and follow through implementation. Must be able to handle matters in a wide range of technology fields, curious, and willing to take on new tasks and continuously learn. Must stay up to date with evolving IP laws in major jurisdictions. Travel Requirements: Up to 5% travel required, mainly in the US to other technology centers. The annual base salary range for this role is currently $180,000 range to $210,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Req ID: 5130 Company: Terumo Medical Corporation Department: TIS Sales - New England Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. **Join us and help shape wherever we go next!** **_Advancing healthcare with heart_** **Job Summary** Serving as a "subject matter expert" (SME), provide product support, education, training and insight regarding the proper use of specialty medical devices for endovascular embolization procedures. Proctor physicians and/or ancillary staff during procedures in which embolization devices are utilized, provide in-services and presentations on technologies, medical devices and on specific embolization procedures to customers. Customers typically include physicians, nurses and other medical personnel. May also extend internally to cross-functional partners. Under minimal direct supervision, provide highly specialized technical training typically in a clinical and/or surgical environment. Work with assigned sub-market team to include Territory Managers, Region Managers, etc. in assigned accounts within the Embo Quarterly Business Review (QBR) process. **Job Details/Responsibilities** Customer Facing: + Train internal (Field Team) and external customers (Physicians, Clinicians, Technicians) on the proper technique and use of TIS embolization product portfolio. + Serve as a company liaison with customers on clinical and technical matters supporting company initiatives, projects and products. + Communicate (verbally or written) with marketing and sales teams to address technical, and clinical issues. + Operate computer medical simulation equipment and support the use of various vessel model units. + Support local/regional/national clinical seminars and medical society sponsored symposia and courses as necessary. + Work with NEBDM, sales team, and marketing, internal departments and customers to resolve clinical and technical related problems. + Visit key customers to evaluate products and help maintain good customer relationships, gain competitive knowledge and new product concepts or product enhancement ideas. + Visit key customers to evaluate products and help maintain good customer relationships, gain competitive knowledge and new product concepts or product enhancement ideas. + Ensure clinical compatibility between all TIS products within the scope of procedural application. + Participate in the QBR process demonstrating understanding of sales processes, effective targeting and operational compliance. + Ensure to the best of their ability TIS products are used appropriately regarding patient safety and intended use. + Marketing, Compliance, Quality and Safety + Work with Marketing and Sales to implement tactics supporting strategic goals and product related tactics. + Follow the established (PPR) Product Performance Reporting process and provide any necessary input. **Job Responsibilities (continued)** + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not limited to the prompt recognition and forwarding of customer complaints (i.e. adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (i.e. branding strategies, product claims, etc.) and materials (i.e. literature) discussed or presented to customers are clinically accurate and adhere to AdvaMed guidelines and Terumo's policy on Interactions with Healthcare Professionals. + Maintain strong knowledge of and adherence to regulations regarding promotional material content and control. Follow procedures for good clinical practices and Design Control when participating in new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. + Perform other job-related duties as assigned. **Working Conditions/Physical Requirements** + This is a field-based position. Must be able to drive personal automobile on a daily basis to/from customer accounts and drive long distances as necessary. + This position, based on organizational needs, will require overnight and occasional weekend travel for training, meetings, region support, etc. Amount of travel will be determined by size of region. + Daily entry into hospitals and other medical facilities is required. Many facilities have instituted vendor credentialing policies which require vendors to meet defined training, background check and proof of immunization requirements as a condition of entry. Terumo Associates entering these facilities are required to abide by these credentialing requirements. + Must be able to gain access to and work in the IR suite, cath lab and operating room. Entry into these areas requires an ability to wear appropriate gowning, standing for long periods of time, complying with hospital policy/protocol and awareness of potential biohazards such as blood borne pathogens. + This position requires working in areas where ionizing radiation is present. Knowledge of radiation exposure and protections is necessary. **Knowledge, Skills and Abilities (KSA)** + Strong technical and clinical knowledge in human anatomy and physiology and medical procedural techniques (endovascular preferred). + Ability to quickly gain a thorough knowledge of company products and their recommended use in various disease states. + Ability to handle customer inquiries and to respond with company information, selected reference material and analyze product applications and misapplications to diagnose product issues relating to usage, manufacture and/or failure. + Strong interpersonal and analytical skills, training and the ability to stay aware of the current technology, company products and generally accepted medical practices related to products and procedural area. + Ability to handle several time constrained projects simultaneously, while meeting the needs of both internal and external customers. + Ability to present and effectively communicate complex clinical and technical data to others of a non-scientific orientation and with varying backgrounds and knowledge levels. + Ability to apply business acumen and understanding to clinical support and customer facing/sales force interactions. + Ability to adapt to changing priorities. + Ability to work in a team environment including in the hospital/lab setting and with local sales team. + Ability to adhere to all company policies and deadlines for all operational aspects of the role, to include expense reports and field inventory, balanced with being in accounts and traveling **Qualifications/ Background Experiences** + Technical or professional health services licensure from an accredited licensing entity. e.g., RT, RCIS, RN or Bachelor's degree in health sciences or related field with a minimum of 3 years' experience in a clinical setting (peripheral and/or cardiology related), or equivalent combination of education and experience. + Must have a minimum of 3 years scrubbing experience within Cath Lab or Interventional Radiology environment or equivalent. + Prior experience as a Field Clinical Specialist with a medical device company is preferred. + Prior experience with endovascular embolization procedures and products is strongly preferred. It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Salary range - $100,000-105,000 **Nearest Major Market:** Boston

Performs inspection and monitoring of all incoming materials that require inspection, including but not limited to packaging, chemicals, subassemblies, mechanical and electrical components. They are inspected in accordance with FDA/GMP requirements and established company SOPs and specifications. Responsibilities Key Accountabilities: Performs professional work requiring application of general and specialized methods, tests, procedures, techniques and instruments as detailed in departmental SOPs. Inspects materials and products, for conformance to specifications, using fixed or preset measuring instruments and/or analysis of vendor supplied documentation. Normally will work under a condition of limited supervision. Ensures materials and products are in accordance with established tolerance levels for quality and performance and are not irregular or damaged. Works with QA, Tech Support and Buyers on a limited basis to resolve, NCRs and other discrepancies. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety of tasks, not limited to inspections. Abilities to be developed at this level for advancement purposes are initiative, follow-up, facilitation, evaluation in detail and responsibility. Primary job functions typically require exercising some independent judgment. Works independently. Placement of Bar Code labels on all in-coming material and use of Bar code reader. All responsibilities required for Inspector I. Data entry of transactions and inspections into SAP. Displays working knowledge in primary inspection responsibility. At direction of Supervisor or Manager will perform special assignments as necessary Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs Skills & Capabilities: Grasps basic Quality Control theories and techniques and ability to implement them. Qualifications Minimum Knowledge & Experience Required for the Position: High School diploma or equivalent with at least 2 years in a Quality Control or Inspection experience. Basic understanding of GD&T and good knowledge of quality control principles. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. International Mobility Required: No Travel Requirements: No The annual base salary range for this role is currently $low range to $high range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Provides analytics and business intelligence insights to enable the North America Commercial Operations leadership team to make informed strategic decisions that drive revenue. The role will act as a consultant to Senior Leadership of Commercial Operations with a focus on reporting, analytics and fostering strong relationships with business partners (eg. Sales, finance, IT). He/she will be looked upon to gather data and perform ad-hoc analyses for the business, develop insights that drive actions and draw upon experience to identify new areas for growth or improvement. Responsibilities Key Accountabilities: Seeks to understand stakeholder needs and develops reporting, dashboards and analysis that enable business decisions to drive revenue and profitability. Uses visualization tools such as MS Power BI to curate and display data from multiple sources. Identifies trends, risks, and opportunities for the business that could impact Commercial Operations objectives, strategy and tactics. Presents insights to Commercial Operations management team to further their understanding of operating results through timely and accurate analyses. Articulates and concisely explains the strategic implications of complex data to key stakeholders. Responsible for continuous improvement related to quality and reliability of data and responsiveness to requests from business. Collaborates regularly with various internal teams, including Finance and IT. Maintains solid working knowledge of the IL business in order to continuously improve analytics. Works on cross-functional projects as required. Performs other duties and responsibilities as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key Relationships North America Commercial Operations Client Services Finance IT Qualifications Minimum Knowledge & Experience required for the position: Education: Bachelor's degree in Business Administration, Finance, Business Analytics or related field required. Master's degree preferred. Experience: Three to five years of work experience in Sales Operations, Finance or Business Analysis function required. Experience in Medical Device/ IVD industry preferred. Additional Skills/Knowledge: Advanced skills with MS Excel required Strong computer skills, including Microsoft Office, databases, web-based applications Experience with data visualization tools such as MS Power BI or Tableau required Experience with CRM and ERP systems required. SAP experience 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: Customer-first mindset. Excellent aptitude for working with large amounts of data and an eye for detail. Highly focused, accurate and thorough in work. Ability to present data to end users in a digestible manner. Proven experience as a collaborative team player Critical-thinking and problem-solving skills. Ability to decipher and interpret complex business challenges. Excellent verbal and written communications skills Ability to work independently to organize and prioritize tasks Able to thrive in a fast-paced, deadline-driven environment Travel Requirements: Up to 25% of the time.

Responsible for overseeing the day-to day activities of the complaint team, works to assure timely case/complaint review and assignment. Responsible for managing the escalation process of potentially reportable complaints with attention to country specific reporting timeliness The QA Manager works with cross func tional teams to support complaint escalations, investigations and field actions. Responsibilities Responsibilities Manages the complaint team to ensure accuracy and timely risk review and thorough complaint investigations are completed. Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards. Ensures timely and thorough review of all com plaints and inquiries, prioritizing potentially reportable events. Escalate any potentially reportable complaint or inquiry, communicates with the cross functional team and management, drives the post market Risk Analysis Worksheet (RAW) process through completion. Communicates updates on escalations, priorities, and complaint status to leadership and in various meetings. Chairing meetings and providing guidance and direction to the RAW team. Trains and develops subordinates, as appropriate, to achieve duties and responsibilities Coordinates and monthly complaint trend review meetings with appropriate departments and ensures that escalations, investigations and CAPA Actions are taken to remediate negative trends or for specific customer complaint issues, determination and resolution of root causes for complaints. Provide complaint inputs to the post market surveillance reporting process Responsible for maintaining Complaint KPI data and reporting as necessary Responsible for gathering complaint and RAW data for Post Market Surveil lance and updating the RA reports including assessing newly identified risks. Follows regulatory requirements for complaint management. Establish and maintain a system to review literature and social media for complaints. Manages tasks supporting complaint investigations, Including returned parts and external as signments. Supports investigation activities and provides guidance for resolving product malfunctions Performs other related duties as assigned. Networking/Key relationships Medical Affairs R&D Regulatory Affairs IT /Cybersecurity Global Affiliates Operations Other technology centers Qualifications Minimum Knowledge & Experience for the position: Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar 10 years (with a Bachelor's) or 8 years (with a Master's) relevant experience. 5 years of supervisory or people management experience. Skills & Capabilities: Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints, and statistical techniques and the ability to train others related to these requirements. Demonstrated ability to organize complex work assignments and oversee analyst to complete tasks and project on time Must possess strong investigational skills to determine root cause, identify and implement effective corrective actions Strong interpersonal communication skills Strong customer focus and continuous improvement mentality. Excellent written and oral communication skills Ability to drive Risk Management, escalation and complaint closure processes. Critical thinking skills, including the ability to analyze and trend data and communi cate concerns as needed. Travel Requirements: N/A The annual base salary range for this role is currently $140,000 range to $160,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. This position provides project/program level leadership, independently develops, applies and implements methods, tools and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service. Provides mentoring and consultation to QE staff on relevant issues. This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls. The position expected to lead by example in alignment with the company values to achieve objectives. Responsibilities Key Accountabilities Essential Functions: Participates in the generation and review of quality documents throughout the product lifecycle Advises and directs teams regarding compliance to procedures, standards and regulations Ensures product quality meets requirements and documentation is complete prior to approval Participates on core teams supporting new product development or design changes Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies. On projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of Werfen products On new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis. Ensures application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution and marketing of Werfen products. Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements Works with manufacturing, R&D, Service, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective/preventive actions (CAPA) Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required. May manage and supervise the work of others Leads cross-functional projects on technical and quality issues Mentors and consults with other QE's and functions regarding application of quality tools and principles Other duties as assigned Secondary Functions: Identifies compliance gaps and takes appropriate corrective actions as needed Supports internal and external audits Leads quality system improvement projects as required. Budget managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on deartment needs, to include interactions such as: Works closely with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations and best practices. Able to effectively communicate quality requirements to a broad population of constituents. Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance. Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Deep knowledge of domestic and international quality/regulatory standards related to our products. In depth knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes. Detailed working knowledge of Werfen products, technology and manufacturing processes including impact on customers and patient requirements. Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk based approach to processes and decisions. Competencies: Attention to Detail: Ability to pay close attention to detail is required Accuracy: Work is accurate and complete Performance Standards: Demonstrated ability to meet department goals Communication: Excellent written, verbal and presentation skills Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality Multi-Tasking: Ability to manage multiple priorities, and support changing business needs Collaboration: Ability to work within a multi-function team to bring best solutions to the team or customer Independence: self-motivated-works under minimal supervision Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers Problem Solving: Promptly and effectively handles issues and problems Decision making: Makes decisions based on data and risk determination Qualifications Minimum Knowledge & Experience Required for the Position: Education: Bachelor's degree or equivalent in engineering or science Experience: A minimum of 12 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 9 years of experience with an advanced degree. Additional Skills/Knowledge: Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering Understanding of the application of technical principles and engineering problem solving to resolve complex issues. ASQ Quality Engineering Certification - Desirable LEAN/Six Sigma Certification - Desirable Language: English International Mobility: Required: No Travel Requirements: Approximately 10% of time The annual base salary range for this role is currently $160,000 range to $190,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

This position will focus on SAP and mainly on the QM module. Candidate will analyze the business needs of users and designs information systems and applications suited to their needs. Programs (ABAP Programming), tests and implements programs, and trains system users under supervision of the IT Development Manager, IT Development Director, or IT Senior Director. Responsibilities Key Accountabilities: Meets with users of assigned functional areas to discuss business needs and procedures. Analyzes and generates functional specifications for information systems. Prepares technical design documentation based on his/her analysis of business functions. Designs program flow charts, data fields and database tables, as well as other documentation which may be required Programs modifications, new custom transactions, utilities and reports. Conducts program tests and corrects any program errors Performs system tests with the support of his/her supervisor and of the lead computer users of the applications developed Prepares end user documentation. Establishes training programs and provides training for users. Work with and guides the SQA Engineers for validating the program developed. Ensure compliance with the security policies established for the acquisition, design, development, operation, administration and maintenance of production systems, operating systems, control of networks and communication systems, databases and related technological resources of Werfen. Budget Managed (if applicable) N/A Internal Networking/Key Relationships: Receives assignments from IT Development Manager or IT Development Director Communicates with IT QA Testers to coordinate quality testing of the software Participates in conversations with key systems users for the assigned tasks. These are required to clarify user requirements, provide training, support and problem resolution. Others as determined based on department needs Skills & Capabilities: Contact with a wide range of users requires clear and effective communication skills, to ensure effective outcome of the development effort. Organizational skills Detail-orientation Time management Functional/Technical skills Analytical skills Team work Qualifications Min Knowledge & Experience required for the position: Experience: A minimum of 3 years of experience in a technical environment and in the software utilized by Werfen is desired. 3 years of minimum experience in computer systems, programming and application concepts, combined with well-developed analytical skills. 3 years of database design experience. International Mobility: Required: no Travel Requirements: The annual base salary range for this role is currently $100,000 range to $135,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

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 (MOP) 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 Internal Networking/Key relationships To be determined based on department needs Qualifications Minimum 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 Skills & Capabilities: Functional/technical skills Travel requirements: The annual base salary range for this role is currently $145,000 range to $170,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

The Project Manager of the Project Management Office (PMO) will be responsible for leading, scaling, and optimizing programs within North America Commercial Operations. This role will define and drive projects using program management strategies, ensuring alignment with organizational priorities and industry best practices in a highly regulated environment. As a key member of the organization, the Project Manager will contribute to the execution, and continuous improvement of project management standards while serving as a cross-functional business partner in business initiatives. This role will drive cross-functional collaboration, ensure project alignment with organizational objectives, and drive a culture of accountability, innovation, and operational excellence. The Project Manager will play a hands-on role, overseeing projects, optimizing resource allocation, and proactively mitigating risks to maximize business impact. Responsibilities Key Accountabilities Project Execution Oversight Manage & execute projects to ensure initiatives are delivered on time, within scope, and on budget, to align with business goals & stakeholder satisfaction. Manage high-impact cross-functional projects, collaborating with key stakeholders to ensure successful delivery and support organizational goals. Track and report on project performance using dashboards and metrics to ensure transparency, accountability, and alignment with project goals. Identify and manage project risks, implementing mitigation plans, proactively identifying and resolving project roadblocks that may impact timelines, scope, or stakeholder expectations. Cross-Functional Collaboration & Executive Engagement Communicate project status, risks, and key insights to stakeholders at various levels to ensure alignment and informed decision-making. Continuous Improvement & Innovation Recommend and apply project management tools & technologies to improve team efficiency, tracking, and visibility throughout the project lifecycle. Support continuous improvement of project management practices by identifying opportunities to enhance agility, scalability, and delivery effectiveness. Promote a culture of continuous improvement, accountability, and innovation within the project teams, ensuring effective delivery and adaptability to evolving business needs. Performs other duties and responsibilities as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Commercial Operations Finance | Client Services Operations | Logistics Medical Affairs Compliance Information Technology Health Care Professionals (Customers) Project Managers & IT Departments Qualifications Minimum Knowledge & Experience for the position: Education Bachelor's degree in business required, project management, STEM or a related field, Master's Degree strongly preferred. Project Management Professional (PMP) certification required. Agile certifications (e.g., SAFe, PgMP, or CSM) strongly preferred. Experience Minimum 4 years of Program Management experience. Demonstrated ability to influence cross-functional teams and drive strategic decision-making. Strong understanding of regulatory environments and biotech industry or hospital integrated networks is 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: Demonstrates strong leadership and stakeholder management skills, effectively collaborating with aligned cross-functional teams and customers to ensure project alignment and success. Proficient in project and portfolio management tools such as Microsoft Project, Jira, Smartsheet, Asana, ServiceNow, supporting efficient planning, tracking, and collaboration. Demonstrates financial awareness by managing project budgets, evaluating cost impacts, and supporting value-driven decision-making. Understands change management principles and supports team adoption of new processes and tools to improve project outcomes. Brings analytical approach to project delivery, interprets data to generate actionable insights, and supports informed decision-making. Communicates clearly and effectively, simplifying complex project information for diverse audiences to ensure understanding and alignment. Demonstrates exceptional emotional intelligence, resilience, and problem-solving abilities in fast-paced, dynamic environments. Effectively manages complex projects involving uncertainty, interdependencies, and evolving stakeholder needs by applying adaptive planning, agile execution, and strong collaboration to mitigate risks and deliver results. Travel Requirements: Approximately 25% of overnight travel is required. The annual base salary range for this role is currently $100,000 to $130,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Under minimal supervision, leads software development activities including software requirements, architecture, design, implementation, and integration. Responsibilities Key Accountabilities Essential Functions: Provides software technical leadership on a software development team. This includes participating in requirements review, design reviews, code reviews, test case reviews, and team meetings. Participate as an active member on a project development team: This includes requirements change control, defect management, risk analysis, and release management. Creates/Maintains software requirement/functional specifications. Creates/Maintains software architecture documentation. Creates/Maintains software (component) design documentation. Creates/Maintains software source code that adheres to design documentation. Performs unit testing and/or code reviews as per project policy. Performs integration testing to ensure software functions within application and with electrical and mechanical devices. Evaluates, investigates, and implements fixes to assigned software defects. Evaluates, investigates, and implements assigned software change proposals. Provides level of effort for assigned software activities Tracks personal estimates over time in order to improve accuracy. Follows project and corporate software plans, standards, and procedures to perform software development Management: Creates/Maintains software project plans. Creates/Maintains software configuration management plans. Coordinates, schedules and supervises software developers for a project Technical: Brings new software technologies into the company. Creates/Maintains applications (utilities) for the project to improve team efficiency, such as hardware control for other engineering disciplines or automated data analyzers for software test. Must have the ability to handle many software components and take ownership for a large percentage of the code base. Must have the ability to take ownership for high complexity implementations. Perform other related duties as assigned Budget Managed (if applicable): N/A Internal Networking/Key Relationships: TBD based on departmental/project needs Skills & Capabilities: Leadership, Management, Team, Individual, etc (for e.g.: holds people accountable, teamwork, delegation, communication, impact and influencing, etc) Consult dictionary of competencies on Manager's Database Ability to administer software engineering tools: configuration management, requirements management, and defect management. Ability to operate instrumentation. Possesses strong written and oral communications skills. Ability to work in a team environment of software developers and testers. Qualifications Min Knowledge & Experience required for the position: Bachelor's Degree plus a minimum of 17 years of related experience or Master's Degree plus a minimum of 15 years of related experience or waiver based on experience. Degree should be in a technical discipline such as Chemistry, Math, Physics, Engineering, or Computer Science. Proficient in code languages (Assembly, C, C++, Java, C#, .NET, etc.) found in product development. Proficiency with a personal computer and software packages Language: English International Mobility: Required: No Travel Requirements: The annual base salary range for this role is currently $200,000 range to $220,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

The Sr. Manager-Risk Management Process is responsible for managing risk processes throughout the product lifecycle, ensuring compliance with ISO 14971 standards, and collaborating with cross-functional teams. This role has responsibilities which include overseeing product quality, process reliability, new product development, validation, assisting with complaint investigations, non-conforming product resolutions, and corrective and preventive actions (CAPA) identifying and solving diverse problems to root cause, and implementing improvements that support business needs and goals. The Sr. Manager- Risk Management Process will for manage technical staff to establish functional goals and meet assigned objectives. The Sr. Manager is accountable for the oversight of activities within the function and for working closely with subordinates by providing regular guidance and general direction to ensure goals are met or exceeded. The position is expected to lead by example in alignment with the company values to achieve objectives. Responsibilities Key Accountabilities Lead cross functional discussions with various R&D and other cross functional design team members to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented. Monitors that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle. Leads periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with quality systems and ensuring compliance with regulatory standards and practices. Leads remediation efforts for updating risk management documents and the implementation of the various risk processes. Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing the firm's risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods. Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with Werfen's strategic objectives. Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams. Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members. Identify opportunities for continuous improvement of the Risk Management Process. Supports R&D projects with software elements and software tools according to corporate priorities to ensure compliance with procedures and regulations Support validation and modifications for software used in the production of Werfen products. Lead internal and external audits for risk-related matters, ensuring compliance with regulatory requirements and industry standards. Collaborate with software, manufacturing, R&D, and others as required to recommend or implement corrective and preventive actions (CAPA). Ensure department targets are consistently met or exceeded through the application of best available manufacturing and development practices. Develop appropriate software quality metrics to identify issues or trends in a timely manner. Lead improvements to key elements of the Quality Management System that supports long term plans to maximize effectiveness and scalability. Ensure department targets are consistently met or exceeded through the application of best available manufacturing and development practices. Make recommendations to management to ensure continued adequacy, suitability, and effectiveness of the QMS. Lead the Risk team with overall management responsibilities, including hiring, goal setting, professional development, mentoring, training, and performance assessment. Deploy technically proficient Risk Quality Engineers to provide quality engineering-based deliverables, including software validation, software risk management, testing methodologies, and compliance with regulatory standards. Establish and manage department budget Perform other duties as assigned. Facilitate and provide ongoing training on standards/processes as needed to other associates or functions. Assist with strategic initiatives and planning. Mentor and coach other members on the team and cross functional teams on risk management processes. Networking/Key relationships Software Engineering Manufacturing Operations Manufacturing Engineering Regulatory Affairs Product Quality & Customer Satisfaction Research & Development Service Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree in engineering, Quality Management, Risk Management, or a related field. Master's degree in engineering, Quality Management, Risk Management, or a related field is preferred. Minimum of seventeen (17) years of experience, or thirteen (13) years with advance degree, within a regulated medical device or pharmaceutical environment. Minimum of five years of risk management experience in the medical device industry, preferably in patient monitoring systems. Minimum of Five (5) years previous supervisory/management experience required. ASQ Certified CSQE, SSBB, CQE or SQE preferred QMS lead auditor certificate preferred Skills & Capabilities: Superior knowledge & application of ISO 14971 and TIR 24971 principles Experience with Systems Engineering-driven processes for ISO 14971 compliance Must be able to demonstrate successes in quality and process improvements, within a medical device or pharmaceutical environment strongly preferred. Expert knowledge of quality engineering principles including risk management, software reliability engineering, software validation, root cause investigation, process validation, process capability, trend analysis, statistical methods and metrology. Excellent project management and problem-solving skills. Strong planning, analytical, organizational and time management skills are required. Able to lead and guide a Validation Review Board to implement validation best practices. Strong leadership abilities required with a focus on collaboration and teamwork. Expert knowledge of US, EU, and international regulations and guidance documents regarding software for medical devices and IVDs, including compliance requirements, validation standards, and cybersecurity considerations. Strong understanding of stakeholder requirements, design inputs/outputs, and hazardous situation analysis. Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including Software Development, AGILE, quality control, manufacturing and design engineering Computer literacy required; knowledge of Microsoft Office, experience with large enterprise resource planning (ERP) system and statistical software required. Experience with JAMA or other relational databases for requirements management is strongly preferred. Strong communication skills to all levels of the organization is required (verbal, written, listening and presentation) Travel Requirements: Less than 5 percent The annual base salary range for this role is currently $160,000 range to $190,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Functional management position responsible for engineering activities an entire Functional Group The position involves management and development of a staff of technical professionals, ensuring projects are staffed adequately and in alignment with corporate objectives. Additional requirements include the ability to drive business results and capability to act as an ambassador of the Werfen culture and values. Will interface and coordinate work activities with Project Management, and other departments such as Software, Analytical, Quality, Service and Marketing. Responsibilities Skill Level and Background: System Experience (Platform Integration/Architecture): Must have a bachelor's degree in Electrical Engineering, Systems Engineering, Software Engineering or closely related field. Advanced degree is preferred Must have a proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability. (10-15 years experience) (team of 10+ ppl strongly desired) Must have strong project-engineering or project-management acumen with deep understanding of traditional waterfall and Agile methodologies. PMP/PMI certifications are a plus. (e.g. resource allocation and workload balancing, work-breakdown structure (WBS), PI planning) Strong Project Management skills & Cross-Functional Leadership Must be a dynamic people leader focused on engagement, empowerment, and results. Player-coach profile desired. Must have experience leading hardware, software, and systems engineering functions as an architect is a must. Instrumentation and measurement equipment background is preferred. Should have experience working alongside reagent development teams. Should act as a functional champion of system engineering discipline across HWE. INCOSE membership a plus. A demonstrated ability in the application of system-level approach to trouble-shooting and root-cause determination. Experience utilizing root-case determination methods (e.g. Ishikawa, 5-Why, Fishbone, etc.) desired. Experience developing and executing comprehensive system strategies for system integration, verification, and validation according to standard operating procedures and design controls. Proven track record in prototyping, rapid iteration, and early-stage product development Understands compliance concepts and testing requirements (IEC 60601) for Noise/EMI/EMC mitigation. Familiarity with Design Control & Risk Management according to international standards (ISO-13485, ISO-14971) desired. Familiarity with Human Factors & Usability Engineering Leadership: Technical authority that helps guide the decision-making process for Coagulation programs Credible leader who can influence with strong organizational and prioritization skills with a results-oriented mindset Leads the definition of the instrument integration strategy driving alignment across cross-functional teams in R&D Leads the development of System Level Architecture Manages a team responsible for planning and execution of the integration strategy together with Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Coag Analytical, and Reagent Development Partner with the Project Manager to define the Integration Schedule and resources (FTE, Instruments, Tools) Drives diverse technical team to find alternative solutions to manage through development and integration roadblocks Supports subsystem teams in managing complexity, interdependencies, modularity Leads the technical decision-making process to drive consensus amongst the core team for go, no-go, or redirect decisions in all phases of the project (concept, feasibility, development) Mentors junior engineers, and are available and engaged with the entire program team Must Have: People Management (team greater than 10 people) Class II or III Medical device experience under IEC 60601, FDA Proven ability to effectively manage a team (Internal and External) Ability to communicate ideas and information clearly, effectively and frequently Direct knowledge of regulatory requirements and industry standards in medical device industry Strong project and people management skills Qualifications Minimum Knowledge & Experience Required Education: Bachelors Degree in Engineering, Science, or related Field. Experience Eight to ten years of product development experience, depending on degree Six years of experience in Functional Management For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience in vitro medical experience highly desirable Additional skills/ Knowledge Language" Proficiency in English language required Skills & Capabilities The ideal candidates for this position will exhibit the following skills and capabilities: Root Cause Analysis, Creative Problem Solving, Critical Thinking Technical capability and confidence Accountability, Decision Making, Influence, Communication Coaching & Mentoring Travel Requirements Up to 10% of time The annual base salary range for this role is currently $180,000 to $210,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service. Responsibilities Key Accountabilities Provide software expertise, leadership, and direction throughout the software development lifecycle with a focus on appropriate and thorough testing. Function as a quality expert for all product development activities by ensuring compliance to applicable standards and regulations. Maintain up-to-date knowledge on cybersecurity requirements and provide leadership and guidance regarding implementation and compliance. Write, review and approve software release documentation and change orders. Provide leadership and guidance in software change control for defect tracking and resolution. Function as the quality expert in software risk management processes throughout the entire software lifecycle. Provide expertise in non-product software validation for software tools used in product manufacturing, product testing and the quality system. Provide software quality engineering expertise to relevant CAPAs and audits. Maintain up-to-date knowledge on software development tools and processes. Participates in the generation and review of Design History File and Risk Management documents throughout the product lifecycle Advises and directs teams regarding compliance of software to procedures, standards and regulations including those related to cybersecurity and privacy requirements. Implements changes to procedures in alignment with evolving regulations. Participates on core teams supporting new product development or design changes Defends relevant quality topics in audits and supports corrective actions to improve and maintain compliance of the QMS Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies. Provides input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis. Works with Project Management, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA) May supervise the work of others Leads cross-functional projects on technical and quality issues Identifies compliance gaps and suggest appropriate corrective actions as needed Supports internal and external audits Leads quality system improvement projects as required Networking / Key Relationships Manufacturing/Operations Manufacturing Engineering Regulatory Affairs Research & Development Service Qualifications Minimum Knowledge & Experience required for the position: Bachelor's of Science degree plus a minimum of 12 years related experience or Master's Degree plus a minimum of 9 years related experience or waiver based on experience. ASQ SQE certification preferred Additional experience working in or knowledge of: Software Engineering Platforms and Applications (Cloud-Based Preferred) Project design, validation, quality plans and risk management (including human factors and Cybersecurity) Preparing submissions, complaint systems and/or authorities reporting activities AI/ML models (desirable) Solid knowledge and experience working with medical device international regulations (FDA QSR, EU Medical Device Regulation, etc.) and related standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366, TIR 57, etc.) Language: English Skills & Capabilities: The ideal candidate for this position will exhibit the following skills and capabilities: Deep knowledge of domestic and international quality/regulatory standards related to both Software in and Software as a Medical Device products (21 CFR Part 820, 21 CFR Part 11, ISO 13485, IEC 62304) Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk based approach to processes and decisions. Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering. Understanding of the application of technical principles and engineering problem solving to resolve complex issues. Membership on external standards organizations of industry groups with influence of our products - desirable. Advanced understanding of software Development Life Cycle Models Advanced understanding of Software Configuration Management (SCM) Strong understanding of risk management and risk management tools (ISO 14971 & TIR 24971) Advanced understanding of software development and testing processes Travel Requirements: Approximately 15% of time The annual base salary range for this role is currently $160,000 range to $190,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

We are seeking a skilled and security-conscious Cloud Engineer to join our dynamic Cybersecurity team. This role is pivotal in designing, deploying, and maintaining our secure cloud infrastructure, with a primary focus on Microsoft Azure and the M365 ecosystem. You will be responsible for translating security requirements into tangible technical controls, ensuring our cloud services are resilient, compliant, and hardened against modern threats. This position directly adds value by enhancing the organization's security posture and enabling the business to leverage cloud technologies safely and efficiently. Your unique contribution will be as the subject matter expert who bridges the gap between cloud infrastructure and cybersecurity policy. Responsibilities Key Accountabilities Design, deploy, and manage secure cloud infrastructure (IaaS, PaaS, SaaS) in Microsoft Azure, ensuring alignment with security best practices and architectural standards. Administer and secure the Microsoft 365 environment, including Entra ID, Exchange Online, SharePoint, and Teams, with a focus on implementing robust security configurations and policies. Implement, manage, and tune M365 security tools such as the Microsoft Defender suite, Purview Information Protection, and Microsoft Intune for endpoint management and data loss prevention. Utilize scripting languages, primarily PowerShell, to automate security tasks, compliance checks, reporting, and administrative routines within Azure and M365. Manage Identity and Access Management (IAM), including roles, permissions, and privileged access (PIM), enforcing the principle of least privilege across all cloud platforms. Configure and manage cloud networking components, such as Virtual Networks (VNETs), Network Security Groups (NSGs), and Azure Firewall to segment and protect network traffic. Monitor cloud environments for security threats, vulnerabilities, and misconfigurations, and collaborate with the Security Operations Center (SOC) during incident response. Create and maintain comprehensive documentation for cloud architecture, security configurations, and operational procedures to ensure clarity and business continuity. Performs other duties and responsibilities as assigned. Networking/Key relationships Cybersecurity Team: Collaborate daily on security strategy, threat intelligence, incident response, and implementing security controls. IT Infrastructure Team: Partner on network integration, on-premises connectivity (hybrid cloud), and core infrastructure dependencies. Application Development Teams: Advise on secure development practices and CI/CD pipelines to ensure applications are deployed securely in the cloud. IT Service Desk: Act as a tier 3 escalation point for complex cloud and M365-related security issues. Compliance & Audit Teams: Provide evidence and support during internal and external audits to demonstrate adherence to security frameworks and regulations. Business Stakeholders: Engage with various departments to understand their needs and implement cloud solutions that enable their goals without compromising security. External Vendors (e.g., Microsoft): Manage vendor relationships for technical support, licensing, and staying abreast of new security features and product roadmaps. Qualifications Minimum Knowledge & Experience for the position: Education: Bachelor's Degree in Cybersecurity, Computer Science, Information Technology, or a related field, or equivalent professional experience. Experience: 3-5 years of hands-on experience in a cloud engineering, systems administration, or cybersecurity role with a strong focus on cloud environments. Direct experience deploying and securing solutions in Microsoft Azure and M365 is required. Skills & Capabilities: Strong proficiency in Microsoft Azure services (IaaS and PaaS), including Virtual Machines, Storage, VNETs, and Azure App Services. In-depth knowledge of Microsoft 365 administration and security features, particularly Entra ID, Defender for Cloud Apps, Defender for Endpoint, and Intune. Experience with Infrastructure as Code (IaC) tools such as Terraform, Azure Bicep, or ARM Templates. Proficiency in scripting languages for automation, with a strong preference for PowerShell. Solid understanding of cloud networking concepts, including VNETs, subnets, NSGs, VPNs, and firewalls. Strong knowledge of core cybersecurity principles: Identity and Access Management (IAM), encryption, logging, monitoring, and threat modeling. Experience with both Windows Server and Linux operating systems in a cloud context. Excellent analytical and problem-solving skills, with the ability to troubleshoot complex technical issues. Strong verbal and written communication skills, capable of explaining complex concepts to both technical and non-technical audiences. Relevant industry certifications (e.g., Microsoft Certified: Azure Security Engineer Associate (AZ-500), Microsoft 365 Certified: Security Administrator Associate (MS-500)) are highly desirable. Travel Requirements: Minimal travel required, approximately The annual base salary range for this role is currently $130,000 range to $160,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Defines and implements market requirements for new products. Product management of a dedicated product line. Prepares marketing support program for a specific product, product line, or product area. Coordinates implementation with technical services and field sales organization. Provides Marketing assistance to field personnel and customers. Responsibilities Key Accountabilities: Key marketing interface with R&D, Operations and QA/RA Prepares and coordinates marketing support programs. Contribute to planning and creation of advertising and promotional materials. Write technical bulletins and newsletters. Keeps informed about developments in medical instrumentation/diagnostic industry as they apply to the company's future marketing plans Provides sales technical training for sales staff. Works with field sales staff to develop training requirements and sales tools required to introduce new products and sales campaigns for all or part of product line. Makes presentations to customers. Understands all maintenance, performance and advantages of Werfen products Understands technical aspects of Werfen and competitive products Monitors field test and marketing introduction programs Maintains regular communications with technical services on problems with instruments and reagents within the product line Interfaces with all levels of management and to independently resolve conflicts/problems with company peers Manages and drives internal projects with minimal supervision Budget Managed (if applicable): N/A Internal Networking/Key Relationships To be determined based on department needs. Skills & Capabilities: Business Acumen Customer Focus Organizational Agility Peer Relationships Planning Skills Presentation Skills Drive for Results Qualifications Minimum Knowledge & Experience Required for the Position: Knowledge in Life Sciences: Medical Technology, Biology, Biotechnology, Chemistry Bachelor's degree in biological science, business administration or marketing discipline, or equivalent. Prior experience in junior marketing product management positions Minimum three years' experience in sales and/or marketing within the healthcare industry International Mobility: No Travel Requirements: Approximately 25% of time The annual base salary range for this role is currently $115,000 range to $140,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

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. 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 asse. 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; Collaborates 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: Ability to plan and conduct work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments Ability to maintain a clear overview of major projects, make sound judgments necessitated by available time and technical capacity to meet set objectives Qualifications Min Knowledge & Experience Required for the Position: B.S. in Engineering and a minimum of 15 years of experience or an M.S. Degree and a minimum of 10 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 preferable International Mobility Required: No Travel Requirements: The annual base salary range for this role is currently $160,0000 range to $190,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.