Terumo Cardiovascular Group jobs in Elkton, MD - 26 jobs

Req ID: 5370 Company: Terumo Medical Corporation Department: TR Band 2 (Mfg) 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** Set up, operate, maintain high speed and/or manual production equipment to efficiently produce a quality product and provide training assistance as needed. Receives requirements for order and up-coming changeovers from Supervisor. Requires minimal supervision. Sr. Manufacturing Operator has responsibility for providing daily work direction and training to other less experienced personnel as requested. Handles higher level problems and troubleshooting and work delegation. May be work independently on an off shift or in place of a supervisor. Should have ability to analyze Non Conformance Reports, Root Cause Analysis and other analytical tools for production reporting. **Job Details/Responsibilities** 1. Associate is responsible to follow requirements of applicable national and international regulations. 2. Continuously monitor machine and the product being produced for potential problems or defects ensuring product according to ISO and government standards. 3. Maintain adequate raw material supply to machines to maintain uninterrupted production cycles. 4. Has demonstrated initiative with ability to work independently. 5. Answer machine alarms and un-jam components as they feed into machines. 6. Demonstrate a practical knowledge of the manufacturing technology by providing improvements and stabilization to the process. 7. Set, control, and confirm process parameters. 8. Properly package plastic component within GMP guidelines. 9. Maintain proper documentation in accordance with section and Company policies. 10. Perform assigned preventative maintenance on machinery and equipment. 11. Instruct and train new operators on a continuing basis as required. 12. Maintain production area in a clean and orderly manner and other duties as needed. 13. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, and change control practices. 14. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement. **Working Conditions/Physical Requirements** Position requires gowning procedures for controlled environment. Typically works around high speed machinery requiring close attention to safety to prevent physical entanglement, product jams, etc. May at times require the use of hearing protection if working in high noise level area. May work with chemicals and solvents requiring special handling and additional personal protective equipment. **Knowledge, Skills and Abilities (KSA)** + Knowledge of mechanics of machine motion and drive. + Ability to readily transfer knowledge to others. + Knowledge of production reporting tools. + Mechanical/electrical aptitude with analytical problem solving skills, flexibility, and understanding of high speed production equipment are essential. Experience in operation of basic machine shop equipment (i.e. drill press, belt sander, grinder, band saw, etc.) and forklift. Organizational skills as well as proper documentation skills. + Aptitude for focused attention and well organized thought process. + Communication skills both verbal and written. + Typically requires occasional individual lifting up to 50lbs and shared lift up to 100 lbs. **Qualifications/ Background Experiences** + Typically requires a high school diploma with a minimum of five years of production maintenance experience. Prefer an AA degree in mechanical or electrical discipline. 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 that allow you to design your own plan based on your individual needs which include: 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. Pay for this position is $26-$32/hour, plus a 15% shift differential.

Req ID: 5324 Company: Terumo Medical Corporation Department: AngioSeal Anchors 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** Set up, operate, and maintain production equipment, automatic and manual in order to maintain a quality product. Requires close supervision, however after initial training, the job is performed with minimal amount of supervision. Expected to make independent decisions when required to do so. **Job Details/Responsibilities** 1. Associate is responsible to follow requirements of applicable national and international regulations. 2. Performs part inspections within specified frequency and process parameters. 3. Set up and changeover production line to produce type schedules. 4. Performs preventative maintenance on equipment. 5. Maintains accurate production records. 6. Maintain a clear and organized work area. 7. Assist with job changeovers as needed. 8. Maintain adequate raw material supply as required. 9. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, change control practices. 10. Perform maintenance/troubleshooting on production process. 11. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement and performs other job related duties assigned. **Working Conditions/Physical Requirements** Position requires gowning procedures for controlled environment. **Knowledge, Skills and Abilities (KSA)** + Ability to work with hand tools and perform mechanical and minor electrical duties where knowledge of the task can be learned on the job. + Makes production set-ups, changeovers to different products operations, adjustments and simple machine repairs to facilitate production. + Required to drive a forklift at certain times. + Must have 20/20 vision or corrective vision and strong attention to detail. + Considerable standing, walking, lifting, etc. **Qualifications/ Background Experiences** + Typically requires a high school diploma. 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. Rate of pay: $21.00/hour.

Req ID: 3876 Company: Terumo Medical Corporation Department: TR Band 2 (Mfg) 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** The Manufacturing Technician maintains all machines in good working order, troubleshooting and repairing any mechanical or electrical failures. Assists Technicians in other departments within the section. Works closely with Central Engineering Group on projects to upgrade equipment. Under general supervision receives instructions by way of electronic transmission, verbal, or written from Supervisor regarding production , maintenance or troubleshooting tasks **Job Details/Responsibilities** . Associate is responsible to follow requirements of applicable national and international regulations. 2. Troubleshoots high speed manufacturing equipment and performs all electrical and mechanical repairs as required 3. Working with Engineering Group on projects that upgrade production equipment 4. Verify that inspection units are functioning properly, heats and pressures are within tolerance amount and condition of raw materials, and that operation of machines are smooth and consistent. 5. To oversee the safety of the personnel and the machinery in the department 6. Perform scheduled repairs, preventative maintenance, and improve machines and auxiliary equipment in addition to repairs for emergency break downs. 7. Set up production equipment and make all necessary quality checks prior to line start up for production 8. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement. 9. Performs other job related duties assigned. **Working Conditions/Physical Requirements** Position requires gowning procedures for controlled environment. Typically works around high speed machinery requiring close attention to safety to prevent physical entanglement. Will require the use of eye protection, and hearing protection w working in high noise level area. Conditions physically demanding when high number of machine break downs. **Compensation and benefits** We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: 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. Rate of pay: $26.00 - $34.00/hour plus a 15% shift differential **Knowledge, Skills and Abilities (KSA)** + Mechanical aptitude is critical, as much of the knowledge needed comes from experience of actual line operation and then working in maintenance with a seasoned technician. + Requires hand eye coordination in making precise and critical adjustments correct the 1st time. + Typically requires exacting attention to work being performed. + Considerable standing, reaching, pulling, stooping, etc. **Qualifications/ Background Experiences** + Typically requires an AA degree in a relevant field with at least 2 years experience to develop problem solving skills and knowledge of todays machine complex electronic controls and instruments, motor drive units pneumatics and hydraulic systems, test and calibration equipment. + Blue print/schematic reading. + Communication skills both verbal and written. 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.

Req ID: 5396 Company: Terumo Medical Corporation Department: Glidesheath 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** The Utility 1 position is a very flexible entry level position that is utilized in several departments throughout the TMC Elkton manufacturing site. While this is the first step in the hierarchy of hourly manufacturing positions, attention to detail and adherence to SOPs, CGMPs, and GDPs are just as critical to patient safety and ability to succeed in this role as these skills and competencies are in more advanced positions. **Job Details/Responsibilities** 1. Associate is responsible to follow requirements of applicable national and international regulations. 2. Closely adhere to all safety requirements 3. Representative operations performed by a Utility I include (but are not limited to): 1. Cutting&Washing 2. Rodding/DeRodding 3. Sheath Tip Forming & Inspection 4. Dilator Tip Forming 5. Silicon Application 6. Hand Assembly 7. Infllate/Deflate (leak testing) 8. RF Welding (PVC welding) 9. Tube or Valve Bonding (gluing) 10. Curvature Insertion 4. Maintains clean work area. 5. Adheres to Good Manufacturing and Good Documentation Practices 6. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement. 7. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, and change control practices. 8. Performs other job-related duties as assigned. **Knowledge, Skills and Abilities (KSA)** + Requires manual dexterity/hand-eye coordination + Ability to precisely adhere to process requirements + Attention to detail + Good communication skills + Ability to work productively in an individual or team setting **Qualifications/ Background Experiences** + High school diploma or equivalent 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. Rate of pay: $17.20/hour. Shift Diff: work 36 hours be paid for 40 hours

Req ID: 5338 Company: Terumo Medical Corporation Department: Applied Technology & Evaluation 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** The Materials & Test Engineer Co-op position will support Test & Evaluation (T&E) and Materials & Coatings (M&C) and will work collaboratively on new product development and sustaining engineering projects and activities. These assignments may include test method development, new product concept testing, formal design verification testing, stability testing, competitive benchmarking, marketing claim substantiation, and all associated technical documentation. The Materials & Test Engineer coop will work closely with materials & coatings engineers and test & evaluation engineers and this work may support a project team allowing for teamwork with product development engineers, systems engineers, process engineers, quality engineers, and manufacturing. **Job Details/Responsibilities** + Support the development and/or implementation of test methods for new products, design changes, sustaining projects, and marketing support. + Support design and development of necessary test fixtures. + Support the execution of testing and materials activities, per defined test plan, protocols, and methods. + Document experimental process in lab notebook and technical reports. + Perform necessary engineering and statistical analysis of collected data. + Contribute to Technical Reports documenting the results of testing performed. + Support root cause analyses for testing and materials related activities. + Prepare and present formal presentations on status and results of assigned work. + Use scientific literature and standards to support test planning, data analysis, and conclusions. + Perform other job-related duties as assigned. **Job Responsibilities (continued)** **Working Conditions/Physical Requirements** **Knowledge, Skills and Abilities (KSA)** + Strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes. + Familiarity with mechanical/electronic/chemical equipment and tools in laboratory testing and of statistical techniques/methods. + Strong communications skills to understand and explain complex engineering problems to non-engineering personnel. + Ability to create detailed Technical Reports to support project deliverables. + Ability to create and deliver presentations to team and managers. + Critical thinking, a desire to learn, and apply new knowledge. **Qualifications/ Background Experiences** + Coursework toward a BS in Mechanical, Biomedical, Materials Science, Chemical Engineering, Chemistry, or similar engineering/science discipline. + Demonstrated successful decision-making skills. Experience with performing analyses and making a recommendation. + Demonstrated analytical and logical problem-solving abilities. + Demonstrated ability to distill complex technical information and explain to a much less technical audience. Experience in presenting and explaining to management. (verbal communication) + Demonstrated strong technical writing skills. (written communication) 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.

Req ID: 5432 Company: Terumo Medical Corporation Department: Elkton Facilities 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** This position is responsible for being an Expert/Lead in HVAC maintenance and the more complex repair and/or replacement of various types of facilities infrastructure in support of a medical device cleanroom manufacturing facility. The primary responsibility is to act as the Expert/Lead technician in the maintenance, repair and operations (MRO) of plant HVAC and equipment while working independently to perform a wide range of complex duties under general guidance. This position is the front-line Facilities Technician responsible for resolving customer complaints regarding the building's HVAC. This position is responsible for coordination between vendors and contractors including the creation and definition of the scope of work, obtaining vendor proposals and approvals, and overseeing contracted services. This position requires advanced knowledge of HVAC, plant operational procedures and tools obtained through extensive work experience and provides training, mentorship, delegating and reviews the work of Technicians earlier in their career. **Job Details/Responsibilities** HVAC Maintenance & Reliability - Provide Expert/Lead troubleshooting, repair, and maintenance; perform preventative maintenance on HVAC systems including Air Handling Units, Refrigeration, Fans, Variable Air Volume (VAV) Terminal Boxes, Chillers, Cooling Towers, Boilers, Coils, Compressed Air Systems, Pumps, Building Automation System (BAS), Heat Exchangers, and other facilities related systems. - Lead maintenance on equipment per schedule and specification to maintain reliability of equipment. Document maintenance records to be compliant with Terumo Quality Standards and 21 CFR Part 11 Guidelines for Medical Devices. - Comply with the requirements of a Cleanroom medical device manufacturing environment (ISO 14644-1) including gowning procedures, particulate control, airlocks, pass-through chambers, etc. Project & Contractor Oversight - Review Service Requests for completeness and accuracy, working with the requestor to ensure job scope and materials are defined. Determine if work will be performed by Facilities Engineering personnel or a contractor or a combination of both. - Lead project scope definition, vendor selection/soliciting vendor pricing (if applicable), estimating project cost, scheduling project work, and coordination in the field. - Develop contract strategies and initiate contracts to reflect scope, period of agreement, and cost. Monitor and address overall contractor performance to ensure they meet expectations. Audit contractor performance including timesheets, safety, quality, cost, and productivity. Document contractor safety orientation with EHS department. Develop and maintain metrics for specific contracts and/or projects (e.g. track expenses, safety performance). Shutdown Coordination & Stakeholder Communication - Coordinate complex shutdowns of impacted equipment and systems with stakeholders. - Provide timely communication to stakeholders regarding project scope, schedule, and impact to manufacturing facility. - Keep Facilities Engineering Manager informed on workload, schedule, and work force requirements. - Availability during July and December site shutdowns is required. Regulatory Compliance & Permitting - Maintain compliance with national, state, and local regulations as well as Terumo EHS procedures and guidelines. - Compliance with EPA and OSHA for hazardous waste control and disposal. - Obtain necessary permits required for specific jobs. Documentation & Inventory Management - Maintain and update site engineering drawings by providing red-lined as-built upon the completion of all work. - Develop new and maintain existing Standard Operating Procedures, ensuring the needs of the organization are met. - Develop and maintain spare parts inventory. - Prepare and maintain logs, monthly reports, inventory reports, etc., as needed. Training & Delegation - Provide training and mentorship to Technicians earlier in their career. - Assign, delegate, and oversee work assignments of early career technicians. - Identify and drive skill development for the team to ensure operational readiness Site Support & Other Duties - Assist Facilities Technicians in other disciplines (General Bldg., Electrician, Electro-Mechanical, etc.) as needed. - Infrequent support at other Terumo sites in Somerset, NJ and Allentown, PA. - Performs other job-related duties assigned. **Knowledge, Skills and Abilities (KSA)** - Requires excellent HVAC aptitude with problem solving skills. - Expert at reading engineering documents and drawings, schematic drawings, shop drawings, operation and maintenance (O&M) manuals, etc. - Subject Matter Expert knowledge of HVAC systems including Air Handling Units, Refrigeration, Fans, Variable Air Volume (VAV) Terminal Boxes, Chillers, Cooling Towers, Boilers, Coils, Compressed Air Systems, Pumps, Building Automation System (BAS), Heat Exchangers, Pressure Vessels, and other facilities related systems. - Strong knowledge of the requirements of a Cleanroom medical device manufacturing environment as outlined in ISO 14644-1, including air filtration for particulate control, airflow control, gowning procedures, airlocks, pass-through chambers, surface materials, environmental monitoring, etc. - Strong organization and record-keeping ability. - Strong knowledge of OSHA, EPA, Federal, State, and Local regulatory requirements. - Effective written and oral communication skills and ability to interact and communicate with a variety of groups (Engineering, Production, EHS, HR, etc.). - Excellent ability to safely use various hand tools, portable power tools, and diagnostic equipment. - Familiarity with Site Services and Maintenance Systems is preferred (e.g. Chiller, Boiler, Water Treatment, etc.). - Computer: Skilled with MS Office 365 Suite (Outlook, Teams, Word, Excel); familiarity with purchasing systems (e.g. SAP Ariba); - Computer: Skilled with CMMS (e.g. Maximo, SAP S4 Hana Fiori) for work order tracking - Ability to work well under pressure in order to meet commitments, both indoors and outdoors in all climates, and be available 24/7 if needed. This position may require alternate shift coverage for limited durations. - Demonstrated ability to work on multiple tasks, including setting and communicating priorities and schedules. - Demonstrated ability to be innovative, self-motivated with minimal supervision. - Ability to operate manlifts, trucks, and forklifts to perform daily maintenance activities and support project execution; Use proper rigging techniques to lift equipment to perform work. - Ability to fabricate and install various piping systems including steel, stainless, copper (sweated/compression), composite piping and glue joints preferred - Must obtain acceptable background check as determined by TMC's reviewing official. **Qualifications/ Background Experiences** - Requires a high school diploma or GED - HVAC/R Masters License in Maryland required - Minimum of 8-10 years of specialized experience in facilities engineering, HVAC systems, and technical project leadership - Proven ability to lead technical teams, drive process improvements, and support strategic initiatives - Strong background in documentation, SOP development, and cross-functional collaboration - Cleanroom manufacturing experience 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. Rate of pay: $42.46 - $58.08/hour

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. **How you'll make an impact:** + Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department + Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties + Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle + Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams + Review and interpret study data analyses + Contribute to the generation of product life cycle plans (e.g., post-market surveillance). **What you'll need (Required):** + Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria + Demonstrated track record in people management or equivalent work experience based on Edwards criteria **What else we look for (Preferred):** + Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Medical writing or regulatory certification or equivalent work experience based on Edwards criteria + Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria + Experience working in a regulated industry or equivalent work experience based on Edwards criteria + Certification in related fields + Strong leadership in project and team management, including coaching and performance oversight. + Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. + Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. + Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). + Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. + Familiarity with coronary interventional and structural heart environments. + Proven ability to develop metrics demonstrating medical writing value to the business. + Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Req ID: 5459 Company: Terumo Medical Corporation Department: QM Laboratory Ops 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** The Lab Technician II is a position within the Laboratory Operations group at TMC Elkton, which is comprised of both Chemistry and Microbiology teams. This role is responsible for general laboratory duties and for performing a variety of sampling, testing, and assays based on the specific functions of the Chemistry and/or Microbiology team within Laboratory Operations. This position will either be Chemistry-focused or Microbiology-focused, and the position will report directly to the Chemistry Manager or Microbiology Manager, accordingly. **Job Details/Responsibilities** 1. General Requirements: 1. Associate is responsible for following requirements of applicable national and international regulations. 2. Maintains awareness, training and knowledge of Terumo Safety Policies and Procedures to assure compliance with regulatory, global and site quality requirements. 3. Can work independently, with minimal guidance. 4. Maintains correct documentation of test results; practices Good Documentation Practices (GDP). 5. Correctly interprets test results and escalates excursions and out of specification results. 6. Completes data entry into designated files or databases. 7. Completes document archiving and retention activities. 8. Performs routine laboratory housekeeping activities, such as waste removal, laboratory cleaning, glassware maintenance, general organizing, etc. 9. Conducts laboratory supply inventory checks and submits purchase requisitions to restock materials, chemicals, and reagents as needed. 10. Performs pH and conductivity testing. 11. Supports sterilization dunnage preparation and maintenance activities. 12. Initiates and supports laboratory investigations and non-conformances. 13. Conducts necessary project work/studies as assigned by management. 14. Performs other job-related duties assigned. **Knowledge, Skills and Abilities (KSA)** + Effective written and verbal communication skills. + Demonstrated logical thought processes and decision-making ability. + Quality consciousness in the ability to recognize and correctly respond to deviations from standard conditions and or procedures. + The ability to prioritize work and maintain focus on the task at hand. + Demonstrated involvement in actively improving Laboratory Operations processes and efficiency. + Ability to make product disposition choices based on quality criteria, test result conformance to specifications, and product requirements. **Qualifications/ Background Experiences** + High school diploma (or equivalent), coupled with a minimum of 5 years of relevant experience in a chemistry and/or microbiology laboratory setting. + Associate's degree in biology, chemistry or related science preferred, coupled with a minimum of 2 years of relevant experience in a chemistry and/or microbiology laboratory setting. + Bachelor's degree preferred in biology, chemistry, microbiology and or related science with 0 - 2 years' experience in chemistry and/or microbiology laboratory setting; experience with aseptic technique and/or chemistry lab instrumentation 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 that allow you to design your own plan based on your individual needs which include: 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. Pay for this position is $44,400-$55,500 per year.

Req ID: 5358 Company: Terumo Medical Corporation Department: Operations Training 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. **Job Summary** The Senior Manufacturing Training Specialist will play a critical role in developing, implementing, and evaluating training programs to ensure operational excellence and compliance across manufacturing operations. This individual will leverage their expertise in training methodologies to enhance workforce skills, improve efficiency, and support continuous improvement initiatives. **Job Details/Responsibilities** + Design, develop, and deliver comprehensive training programs for manufacturing employees, focusing on Job Instruction (JI), Job Methods (JM), and Job Relations (JR) based on TWI principles. + Utilize adult learning methodologies and hands-on techniques to engage diverse learning styles effectively. + Develop training materials, including work instructions, SOPs, and visual aids. + Serve as a subject matter expert for TWI, driving adoption and continuous improvement. + Assess training needs through job task analysis, skill gap identification, and collaboration with manufacturing leadership. + Monitor and evaluate the effectiveness of training programs using Key Performance Indicators (KPIs) + Prepare and present reports summarizing training completion, effectiveness, and ROI, using Microsoft tools. + Partner with cross-functional teams, including quality, production, HR, etc. to ensure training programs align with organizational goals. + Support process improvement initiatives by analyzing training gaps and implementing solutions to enhance efficiency and compliance. + Mentor and coach manufacturing floor trainers to ensure consistent training delivery and high-quality outcomes. + Ensure production training is based on the relevant SOPs and delivered in a complete, effective, and consistent manner across workstations and departments + Maintains all manufacturing training records as required. + Maintain working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDPs) and monitor records to ensure GDP. + Provide timely and effective training support identified Corrective and Preventative Actions (CAPA) and Nonconformances (NCs). + Maintain flexibility in schedule to support all shifts. + Performs other related duties as assigned. **Knowledge, Skills and Abilities (KSA)** + Deep understanding of adult learning principles, instructional design, and hands-on training techniques. + Knowledge of TWI + Familiarity with manufacturing workflows, equipment, and SOPs + Understanding of medical device manufacturing industry regulations, and quality control (ISO Standards, FDA Regulations, etc.) + Proficiency in Microsoft Office. + Knowledge of organizational change management strategies to support new training program rollout. + Ability to design, deliver, and evaluate effective training programs tailored to manufacturing employees. + Excellent communication skills + Proven experience in conducting individualized and group training in a production environment. + Strong ability to read, understand, and work with detailed visual aids such as method layouts, detailed diagrams, schematics, process flow sheets, related assembly documentation, and other documented practices. + Strong organizational skills and attention to detail. + Strong writing, problem-solving, and analytical skills. + Can communicate effectively with all levels of the organization. **Qualifications/ Background Experiences** + Deep understanding of adult learning principles, instructional design, and hands-on training techniques. + Knowledge of TWI + Familiarity with manufacturing workflows, equipment, and SOPs + Understanding of medical device manufacturing industry regulations, and quality control (ISO Standards, FDA Regulations, etc.) + Proficiency in Microsoft Office. + Knowledge of organizational change management strategies to support new training program rollout. + Ability to design, deliver, and evaluate effective training programs tailored to manufacturing employees. + Excellent communication skills + Proven experience in conducting individualized and group training in a production environment. + Strong ability to read, understand, and work with detailed visual aids such as method layouts, detailed diagrams, schematics, process flow sheets, related assembly documentation, and other documented practices. + Strong organizational skills and attention to detail. + Strong writing, problem-solving, and analytical skills. + Can communicate effectively with all levels of the organization. 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. Rate of pay: $72,000 - $79,200.00/year.

Req ID: 5418 Company: Terumo Medical Corporation Department: Environmental, Health & Safety 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** The Health and Wellness Manager is a high-impact role with the opportunity to drive meaningful change across the organization. This position spans multiple sites and departments, serving as an integral leader in advancing Terumo's health and well-being objectives. In this role, the Health and Wellness Manager will design and implement innovative strategies and programs that foster a culture of health and safety. The position involves cross-functional collaboration, mentoring team members, and reporting directly to the Sr. Manager of EHS. Key responsibilities include managing all work-related injuries and illnesses, overseeing direct care for associate injuries (including emergency situations), and identifying trends to lead corrective actions. Additional duties include developing treatment protocols, preventive and emergency care guidelines, and return-to-work programs for occupational injuries. At times, consultation with HR on non-work-related health concerns may be required. The role also partners with business leaders to prevent illness and disease within facilities while promoting overall employee health and wellness. Responsible for designing and optimizing innovative strategies and programs that fosters a culture of health that advance Terumo's health and well-being objectives. This role will coordinate cross-functionally and serve as a leader and mentor to immediate team members. **Job Details/Responsibilities** Develop and Execute Strategies and Initiatives + Develop and oversee the execution of multi-year strategic plans targeting healthcare and well-being improvements, including non-occupational health onsite and/or near-site clinics + Lead the identification of emerging trends, opportunities, and challenges in healthcare and employee well-being, adapting plans accordingly + Align healthcare and wellness strategies with Terumo's business goals, values, and culture Design and Manage the Health and Wellness Program + Design, launch, and manage comprehensive health and wellness programs, ensuring they meet needs of employees + Oversee the integration of physical, emotional, and financial well-being initiatives, including preventive care, mental health support, and chronic condition management. + Establish metrics for program effectiveness and drive continuous improvement through data-driven insights. Engage and Integrate Internal and External Stakeholders and Resources + Build and maintain relationships with internal stakeholders, including but not limited to Operations, HR, Legal, and Leadership + Engage with external partners such as healthcare providers, insurance carriers, wellness consultants, and community organizations + Facilitate cross-functional teams to deliver integrated healthcare and well-being solutions. + Analyze health and wellness data to identify opportunities for improvement and demonstrate program impact Foster and Progress Culture and Engagement + Monitor and communicate regulatory changes or industry best practices affecting health and well-being programs + Serve as a thought leader and mentor to staff and cross-functional team members + Foster a culture of health, inclusion, and engagement throughout the organization + Champion well-being initiatives at all organizational levels, modeling behaviors and practices **Job Responsibilities (continued)** Strategic Planning & Reporting + Prepare detailed reports and presentations for senior leadership, translating complex data into actionable recommendations + Develop and manage budgets for healthcare and wellness initiatives, ensuring effective allocation of resources + Identify opportunities for cost savings without compromising on quality or outcomes + Ensure all healthcare and well-being programs comply with applicable laws, regulations, and organizational policies + Process Optimization & Continuous Improvement + Develop outlines for treatment protocols for treating various types of industrial injuries + Create, integrate and continually improve a Corporate Occupational Health Program + Generate and share metrics and leading/lagging indicators and communicate proposed action plans + Stay up-to-date on current health and wellness trends, research, and best practices to continually improve and evolve the program. Training & Development + Promote health and wellness through the supervision of dissemination and deployment of credible educational materials, workshops, presentations, and organizational events + Provide instruction on various health topics, including exercise, nutrition, and preventive care. + Lead a health and wellness team to develop workplace community health awareness and health outreach strategy, materials, and educational programs Lead and Develop + Supervise, mentor, and develop a small team of direct reports to build a high-performing team capable of delivering complex projects effectively; as well as executing the people manager goals, objectives, and responsibilities. + Provide business insight to direct reports for executing immediate needs and planning long term visions **Knowledge, Skills and Abilities (KSA)** Knowledge + Knowledge of healthcare regulations, compliance requirements, and industry best practices. + Experience in value-based healthcare arrangements, non-occupational health onsite or near-site clinics, healthcare and pharmacy design and innovation Skills + Demonstrated leadership and coaching skills. + Demonstrated ability to develop and manage budgets and vendor relationships. + Exceptional strategic thinking and analytical abilities. + Proven leadership, communication, and problem-solving skills. + Hands-on experience with program management, manufacturing and general industry preferred. + Proficiency in documentation systems and data analysis tools. Abilities + High degree of professionalism, discretion, and ethical standards. + Ability to work effectively in a fast-paced, dynamic environment. + Proficient in data analysis and reporting, with experience using relevant software and tools. + Excellent written and verbal communication skills, with the ability to influence at all levels. + Strong project management and organizational skills. **Qualifications/ Background Experiences** + Education: Bachelor's degree in healthcare administration, nursing, public health, human resources, business, finance, or related field required. Master's degree preferred. + Experience: Minimum of 5 years' experience in healthcare strategy, employee well-being, wellness program management, or a related field, preferably in a complex or large organization. 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. Pay range is $96,000 - $134,000

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Req ID: 5194 Company: Terumo Medical Corporation Department: Machine Design & Controls 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** The Manager position is responsible for leading a team of engineers and technicians in planning, directing, and implementing projects to improve both current and new processes and manufacturing automation. This person will oversee the development and management of the team resources and processes required to ensure functional excellence and delivery of robust high-quality manufacturing processes to operations customers. This role will be tasked with building, developing, and empowering a strong team capable of fulfilling needs for the business. **Job Details/Responsibilities** + The Manager is responsible to follow and direct the requirements of TMC Quality System related to engineering and process control systems; including but not limited to: process controls, calibration and maintenance practices, document/data control, change control practices. + Provide knowledge and leadership required to plan and implement projects to develop, install, and qualify new processes for manufacturing new products or for improving existing processes to achieve business plan objectives. + Provide Process Development expertise in the design, fabrication, development, installation, and qualification of equipment which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment. + Provide guidance and oversight for Automation Development and Procurement for changes to existing and new products/processes. + Drives the use of statistical and six sigma tools to identify and implement root caused solutions. + Oversees engineering efforts on cost savings opportunities, capacity needs, and support for new products. + Ensure optimization and improvement of equipment and processes for long term robustness and reliability. + Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. + Manage the workload and deployment of a team of associates to ensure support of the business by evaluating resource supply vs. demand and ensuring an appropriate organizational structure and skillset/experience mix is created. + Participates in project performance team meetings on behalf of the job unit to provide ideas, methods, or processes for unit/company performance improvement. + Responsible for projects which coordinate with other department's personnel for completion, including guidance for direct reports within the project processes. + Performs other job-related duties assigned. **Knowledge, Skills and Abilities (KSA)** + Must have excellent leadership skills in inspiring, driving, and executing results through others. + Must demonstrate and model effective listening, written and verbal communications, sound logical judgment, and organizational skills, while at the same time creating in others both a sense of urgency and a commitment to excellence. + Demonstrated competency in leading teams in the development of complex technical solutions from concept to commercialization. + Demonstrate clinical knowledge for the product application, and the understanding of the rationales for identifying CTQ attributes and correlate them with the appropriate manufacturing process. + Strong understanding and application of statistical and engineering tools to champion a risk based approach to Process Characterization. Experience, training, or certifications in Lean manufacturing techniques is a plus. + The ability to collaborate cross functionally and lead In-house and Contract employees and to ensure our Mfg processes are Compliant and Robust. + Demonstrate expertise in manufacturing automation development and procurement from outside suppliers. + Demonstrate expertise in the Characterization and Manufacture of disposable medical products. Fully proficient at documenting processes, validations, engineering studies, and test methods. + Excellent communication skills both verbal and written is required. **Qualifications/ Background Experiences** + BS in Mechanical Engineering, Chemical Engineering, or related field, Advanced Degree (MS / PhD) preferred. + Minimum 6 years' experience of progressive experience in an Engineering discipline is required. + Minimum of 3 years leading others and implementing processes for the manufacture of Medical devices + Experience in development and manufacturing of catheter and medical device manufacturing processes (e.g. extrusion, lamination, injection molding, tipping, shaping, bonding, etc) is a plus. 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. Range is $120,000 - $175,000

Req ID: 4974 Company: Terumo Medical Corporation Department: PM&PD Management 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** The Principal Engineer - Automation and Controls is a highly experienced expert role responsible for advancing complex technical projects independently or as part of a team. This position involves providing strategic inputs and technical expertise to support a portfolio of projects, focusing on Process Controls, Automated Systems, and Operational Technology (OT). The Principal Engineer will oversee the Automated System Lifecycle definition, design, development, integration, and validation of new or modified manufacturing processes from concept through commercialization, ensuring smooth product launch and transfer into the manufacturing Value Streams. In addition to the above, the Principal Engineer - Automation and Controls Engineering position is accountable for providing sound technical leadership to new product and process development activities by providing technical direction, insight and coaching to project technical leaders and process leaders in solving complex product/process design, development, and production issues. The Principal Engineer - Automation and Controls Engineering is expected to participate in solving the most complex technical and development issues requiring resolution. Depending on the department, the Principal Engineer may have direct reports with managerial responsibilities or will oversee project teams with overall responsibilities for complex projects. **Job Details/Responsibilities** 1. Technical Leadership: a. Lead the design, development, and qualification of products, processes, and control systems in compliance with TMC Quality System requirements and regulatory standards. b. Provide strategic guidance and technical support in management and executive meetings, contributing to department strategies and initiatives. c. Provide technical direction, insight, and coaching to project leaders in solving complex product/process design, development, and production issues. d. Ensure all automation and control systems comply with FDA regulations, ISO standards, GMP requirements specific to medical devices and all national regulations. 2. Automation Solutions: a. Offer insights and guidance on process control systems for designing automated solutions for new or modified production processes. b. Serve as the Subject Matter Expert for Process Controls, Automated Systems, and OT in new product introduction processes. c. Lead the design, development, programming, testing, and implementation of new or novel control system designs and automated production processes. d. Develop complex technical strategies for projects involving new smart technologies for product/process improvement. e. Design, develop, commission, and validate processes, ensuring the integration of innovative technologies. 3. Process Improvement: a. Develop and implement Process Controls and Automation design standards incorporating new industry technologies to advance manufacturing infrastructure. b. Lead broad process improvement initiatives to enhance team efficiency and functionality. 4. Project Planning and Execution: a. Participate in design reviews, project planning activities, and formal project reviews. b. Prepare and present technical presentations to various levels of personnel, ensuring clear communication of technical activities. c. Efficiently manage resources, including time, budget, and personnel, to ensure successful project completion. 5. Cross-Functional Collaboration: a. Foster effective working relationships with senior engineers and leaders in Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing. b. Attend business meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication. c. Work collaboratively with cross-functional teams, including engineers, quality assurance, and production staff, to ensure seamless integration of automation solutions. 6. Perform other job-related duties when assigned. **Working Conditions/Physical Requirements** This position will be located in the Terumo facility located in Elkton, MD. The position will perform required duties in an office environment, the Product Development Laboratory and Process Pilot area, and within manufacturing areas. Access to hospitals and hospital operating rooms might be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities. **Knowledge, Skills and Abilities (KSA)** Technical Leadership: a. Extensive experience in developing automated manufacturing processes for medical devices or other regulated industries. b. Expertise in industry standards and systems, including electrical codes, PLCs, HMI, SCADA, DCS, industrial robots, motion control systems, sensors, actuators, vision systems, data historians, MES, IoT, Industry 4.0, cybersecurity, and data integrity for OT systems. 2. Communication Skills: a. Exceptional ability to learn new technologies and explain complex engineering problems to non-engineering personnel. b. Proficiency in creating and delivering presentations to executive management and preparing detailed technical reports for regulatory bodies like the FDA. 3. Problem-Solving Skills: a. Strong troubleshooting skills for equipment and instrument issues. b. Effective use of MS Office Suite and CAD software for electrical and mechanical design. **Qualifications/ Background Experiences** 1. Education: BS in Electrical Engineering, Mechanical Engineering, Computer Engineering, or related technical field, or equivalent experience. 2. Experience: 15+ years in process control system design, automation, and integration within research and manufacturing environments in the medical field. 3. Certifications: Certified Automation Professional (CAP) and Lean & Six Sigma Black Belt (SSBB) are desirable. 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. Pay range is $141,000 - $205,000

Req ID: 5329 Company: Terumo Medical Corporation Department: Glidesheath 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** The Utility 1 position is a very flexible entry level position that is utilized in several departments throughout the TMC Elkton manufacturing site. While this is the first step in the hierarchy of hourly manufacturing positions, attention to detail and adherence to SOPs, CGMPs, and GDPs are just as critical to patient safety and ability to succeed in this role as these skills and competencies are in more advanced positions. **Job Details/Responsibilities** 1. Associate is responsible to follow requirements of applicable national and international regulations. 2. Closely adhere to all safety requirements 3. Representative operations performed by a Utility I include (but are not limited to): 1. Cutting&Washing 2. Rodding/DeRodding 3. Sheath Tip Forming & Inspection 4. Dilator Tip Forming 5. Silicon Application 6. Hand Assembly 7. Infllate/Deflate (leak testing) 8. RF Welding (PVC welding) 9. Tube or Valve Bonding (gluing) 10. Curvature Insertion 4. Maintains clean work area. 5. Adheres to Good Manufacturing and Good Documentation Practices 6. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement. 7. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, and change control practices. 8. Performs other job-related duties as assigned. **Knowledge, Skills and Abilities (KSA)** + Requires manual dexterity/hand-eye coordination + Ability to precisely adhere to process requirements + Attention to detail + Good communication skills + Ability to work productively in an individual or team setting **Qualifications/ Background Experiences** + High school diploma or equivalent 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. Rate of pay: $ 17.20/hour plus 10% shift differential

Req ID: 5357 Company: Terumo Medical Corporation Department: TIS Design Assurance/Quality Engineering The Design Quality Engineer (DQE) II will plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) and/or Sustaining Design Changes projects to ensure compliance to internal and external requirements during the development and commercialization of new products. This individual will provide overall Quality Assurance (QA) leadership and partner with the NPD organization in efficient, effective, and rapid development and commercialization of new products. This individual will manage the effective oversight of Design Quality activities, as well as participate as an active QA representative on project teams. The DQE II manages the daily operation of the Design quality aspects of one or multiple projects by ensuring timely completion of Design Quality Assurance deliverables that meet the company standards for quality. This individual provides NPD teams with clear, consistent, and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies, and Terumo business requirements. As part of a project team, the DQE II will be responsible for developing sound Design History File deliverables, including, but not limited to, Quality Plans, Manufacturing Quality Plan, Design Verification protocols and reports, and conducting Design History File reviews at the end of each design control phase. In addition, the Principal, NPD QE will actively participate in design characterization, risk management activities, and design and process validation. The salary range for this position is $75,120 - $104,500 based on experience plus an annual 8% target bonus. **Job Details/Responsibilities** + Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards. + Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities. + Lead quality system development and implementation throughout product life cycle + Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non-conforming materials, and measurement system evaluations. + Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs. + Review and approve/reject technical transfer plans and reports from the design transfer perspective. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and evaluated. + Lead teams and ensure completion of Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with limited guidance required. + Leads cross functional team on how to documents changes, using a risk-based approach for determining requirements. + Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other related products. + Develop and validate test methods. + Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements. + Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. + Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with moderate complexity. + Review and approve product and process qualification and validation and other change control related documentation. + Active role in improving and drafting internal quality documentation such as quality plans, standard operating procedures, and inspection procedures. + Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints. + Performs analytical measurements and experiments to qualify or resolve product and process issues. **Job Responsibilities (continued)** + Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions. + Support field quality and analyze field returns to determine root cause. + Provide training and support for quality system processes and quality engineering practices. + Provide support as a Quality Assurance Team member to work with Engineering and Systems Teams to resolve issues related to Design Verification and Design Validation. + Clear understanding of Process Validation Principles and ability to support Process Qualification efforts (IQ, OQ, PQ etc.) for all classes of medical devices. Internal contacts: All departments, including manufacturing, engineering, marketing/sales. External contacts: Customers and vendor contacts as required. **Knowledge, Skills and Abilities (KSA)** + Effective communication skills both verbal and written. Communicates effectively with internal teams and may present findings to small groups. + Strong organizational skills as well as time management skills essential for project work. + Self-motivating and able to balance multiple priorities and tight deadlines with limited supervision. + Excellent computer skills + Strong writing, mathematics, and statistics skills + Demonstrated working knowledge of key medical device related standards including 21 CFR 820 (Quality Systems Medical Devices), Design Controls, ISO 13485, and ISO 14791. + Basic experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is desired. **Qualifications/ Background Experiences** + BS in engineering, biomedical, life sciences, or similar discipline from an accredited university or college. + Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and/or manufacturing. + Minimum of 3 years of experience in an engineering and/or scientific environment + Minimum of 2 years of experience in a regulated industry (medical device industry preferred)

Req ID: 5366 Company: Terumo Medical Corporation Department: Manufacturing Engineering 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** This role is responsible for supporting the performance, safety, reliability, and quality of products and equipment at Terumo Medical Corporation's Elkton, MD facility. The position focuses on investigating, planning, and implementing changes related to existing products, new product introductions, and manufacturing process improvements. It requires hands-on technical support, documentation, and collaboration across engineering and operations teams. **Job Details/Responsibilities** - Provide technical support to machine operators and technicians by troubleshooting equipment and resolving manufacturing issues to ensure continuous production. - Plan and implement equipment upgrades and modifications to improve performance, address obsolescence, and support new product introductions. - Develop and maintain technical documentation and safe operating procedures in compliance with regulatory and quality system requirements. - Collaborate with cross-functional teams to execute process and equipment validations, ensuring compliance and operational readiness. - Train production personnel on equipment operation and safety protocols to ensure consistent and safe manufacturing practices. - Participate in project teams to contribute ideas and methods for performance improvement and operational efficiency. - Maintain positive communication and collaboration with internal teams, contractors, and vendors to support engineering and production goals. **Knowledge, Skills and Abilities (KSA)** o Knowledge of Industrial controls components, motors, PLCs, HMIs and robots. o Familiar with NFPA 70 (NEC) and NFPA 79 o Ability to read and update electrical schematics o Strong electrical troubleshooting skills and use of measurement tools and other calibrated devices o Considerable standing, reaching, pulling, stooping, etc., with occasional assistance lifting of weights up to 100 lbs. SHARED LIFT o Demonstrated electrical skills with the ability to support the installation and troubleshooting of controls components, vison systems, and high precision measurement devices for industrial equipment upgrades or replacement.. o Understanding of machine change orders, equipment installations and functional verification of industrial manufacturing equipment. Ability to make precise adjustments and measurements to delicate equipment. **Qualifications/ Background Experiences** o Electrical Technology AAS degree or demonstrated relevant work experience. o Minimum of 7 Years Experience in a mechanical or electrical capacity o Experience in medical device industry and manufacturing environment a plus. o Certified electrician or electrical skilled trades highly desirable o Building and wiring electrical control panels o Experience with data networking o PLC ladder logic and configuring electrical components 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. $33.90 - $47.00/hr

Req ID: 5409 Company: Terumo Medical Corporation Department: Injection Molding & Extrusion 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** Set up, operate, and maintain production equipment, automatic and manual in order to maintain a quality product. Requires close supervision, however after initial training, the job is performed with minimal amount of supervision. Expected to make independent decisions when required to do so. **Job Details/Responsibilities** 1. Associate is responsible to follow requirements of applicable national and international regulations. 2. Performs part inspections within specified frequency and process parameters. 3. Set up and changeover production line to produce type schedules. 4. Performs preventative maintenance on equipment. 5. Maintains accurate production records. 6. Maintain a clear and organized work area. 7. Assist with job changeovers as needed. 8. Maintain adequate raw material supply as required. 9. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, change control practices. 10. Perform maintenance/troubleshooting on production process. 11. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement and performs other job related duties assigned. **Working Conditions/Physical Requirements** Position requires gowning procedures for controlled environment. **Knowledge, Skills and Abilities (KSA)** + Ability to work with hand tools and perform mechanical and minor electrical duties where knowledge of the task can be learned on the job. + Makes production set-ups, changeovers to different products operations, adjustments and simple machine repairs to facilitate production. + Required to drive a forklift at certain times. + Must have 20/20 vision or corrective vision and strong attention to detail. + Considerable standing, walking, lifting, etc. **Qualifications/ Background Experiences** + Typically requires a high school diploma. 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. rATE OF PAY: $21.00/HOUR PLUS 15% Shift Differential

Req ID: 5281 Company: Terumo Medical Corporation Department: PM&PD Management 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** The Senior Engineer II, Process Development (NPI) is an intermediate expert level role who independently leads significant technical projects and serves as a key contributor to major process development initiatives within New Product Introduction (NPI). This role involves applying advanced knowledge of Manufacturing Process Strategies, DFM/DFA, Lean, and Six Sigma to design, develop, integrate, and validate robust manufacturing processes into the Value Streams. The Senior Engineer II provides technical leadership within NPI project teams, mentors junior engineers, and plays a vital role in ensuring technical quality and successful implementation for new product launches. **Job Details/Responsibilities** Technical Leadership: + Independently for mid-scale projects designs, develops, integrates, and validates new or modified manufacturing processes to support New Product Introduction (NPI) in compliance with TMC Quality System requirements and regulatory standards. + Applies extensive technical knowledge and experience to lead complex process developments design and validation efforts. Possesses deep expertise in Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes. + Participate R&D and Design Engineering teams during early product development in the identification, evaluation, and implementation of new process technologies and equipment to improve OEE and reduce manufacturing cost. + Leads the identification and documentation of critical process parameters (CPPs), material specifications, and equipment needs for NPI projects. + Solve complex technical challenges encountered during NPI and scale-up. + Provides technical leadership and mentorship to junior engineers and project teams within NPI projects. Process Development and Innovation + Enforce Manufacturing Process Design standards. + Apply Design For Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes. + Contributes to the development of new process technologies for NPI projects, considering factors like OEE and manufacturing cost. + Lead execution of proof-of-concept for manufacturing methods for NPI. + Lead the execution of laboratory-polit scale processes and prototypes into scalable manufacturing processes by identifying critical process parameters (CPPs), material specifications, and equipment needs at platform level. + Develop and lead process risk analysis (EFMEA, pFMEA) and execute process development activities including, commissioning (URS/FRS/Traceability Matrix), characterization and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards. + Lead the technical execution acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation. + May contribute to the assessment of Patent Situation Statements and intellectual property strategy related to manufacturing processes for new products. + Apply knowledge of industry's common business transaction systems (e.g., SAP, MES, Change Control, Ariba) + Lead improvements activities using Lean and Six Sigma methodologies applied to NPI processes. Project Planning and Execution: + Manages all technical aspects of assigned projects, including planning, execution, and reporting, often overseeing the work of less experienced engineers. + Contributes significantly to project scope definition, budgeting, scheduling, and risk assessment. **Job Responsibilities (continued)** Design Transfer & Scale-Up + Lead scale-up of laboratory or pilot processes to industrial production settings-including specification of equipment, methods, automation, throughput planning, and cost targets for assigned NPI projects. + Lead executions of design transfer frameworks for assigned projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology transfer documentation. + Contributes to the development and refinement of design transfer processes for NPI projects. Cross-Functional Collaboration: + Collaborates effectively with cross-functional teams including Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing. + Attend project meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication. + Communicates complex technical information effectively, resolve technical issues, and ensure successful project delivery. Perform other job-related duties when assigned. Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large. **Working Conditions/Physical Requirements** Technical Leadership: + Demonstrated experience in developing, scaling, and validating manufacturing processes for medical devices or other regulated industries. + Advanced understanding of materials, equipment selection, and process technologies such as molding, joining, assembly, laser processing, or other advanced manufacturing methods used in medical device production. + Advanced understanding of Design for Manufacturability (DFM), process characterization, DOE, and statistical analysis. + Familiarity with automation, Industry 4.0 concepts, and equipment integration a strong plus. + Strong knowledge of FDA regulations, ISO 13485, GMP, and risk management practices (e.g., FMEA, pFMEA). + Demonstrated experience in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred. Communication Skills: + Strong ability to communicate technical information clearly and effectively to project teams, management, and stakeholders. + Proficient in preparing technical documentation and presentations. Problem-Solving Skills: + Advanced level understanding of root cause analysis, troubleshooting, and resolution of complex manufacturing and product development issues. + Proficient in tools such as Minitab, JMP, and MS Office Suite; working knowledge of CAD and PLM systems is a plus. + Effective use of MS Office Suite **Knowledge, Skills and Abilities (KSA)** Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Master's degree desirable. 10+ years in process development, manufacturing engineering, or product development, with at least 6 years in the medical device or other highly regulated industry. Lean Six Sigma 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.

Req ID: 5336 Company: Terumo Medical Corporation Department: Product Development 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** The NPD Engineer Co-op position is responsible for providing technical expertise, leadership and planning to small projects or small portions of large projects. The NPD Engineer Co-op is typically a technical team member. The NPD Engineer Co-op position is specifically accountable for the product design, development, testing, and/or technical problem solving. This position executes the Design for Excellence (DFX) aspect of the processes and product design. **Job Details/Responsibilities** 1. Perform the design, development, and qualification of products and processes. This may include feasibility studies, designing & implementing evaluations (DOEs) and providing technical input for justification of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOP, and for providing training to ensure proper design transfer. 2. Implement projects to design, evaluate and qualify new processes for manufacturing new products or improving existing products / processes. 3. Perform as a Technical team member on a large project to develop and implement the technical aspects involving design, prototype fabrication and/or testing. 4. Develop and execute projects in accordance with Terumo new product development process in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements for medical devices. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements. 5. Contribute to project performance team meetings in order to provide ideas, methods, or designs for performance improvement. 6. Prepare & present small technical design reviews to a cross-functional and technical team. 7. Prepare and present product designs, production processes and related activities to management. 8. Communicate with various levels in other sections within Terumo for related projects or progress (i.e. daily interactions with managers, supervisors, NPD engineers and technicians, production personnel, purchasing, logistics, etc...). 1. Implement product performance. Define and write test plans/protocols, perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports. These reports could be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 2. Performs other job related duties assigned. **Working Conditions/Physical Requirements** This position will be located in the Terumo manufacturing facility located in Elkton, MD. The position will perform required duties in an office environment, the NPD Laboratory and sometimes within manufacturing areas. Access to hospitals and hospital operating rooms could be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities. **Knowledge, Skills and Abilities (KSA)** Required: Strong written and verbal communications skills. Ability to understand and explain complex engineering problems to non-engineering personnel. Ability to create and deliver presentations to management and/or a technical team. Ability to create detailed Technical Reports appropriate to send to the FDA. Required: Ability to perform comparative analysis on alternate product designs, component sources, process methods, or test methods and make a recommendation. Required: Analytical and problem solving skills; ability to solve problems and implement solutions or processes. Required: Ability to create and work from engineering drawings and/or specs of products, components, and Marketing requirements. Required: Familiarity with mechanical/electronic/chemical equipment and tools in laboratory testing. Preferred: Practical knowledge of statistical techniques/methods. Knowledge of prototype build methods. Preferred: General knowledge of computer aided design, specifically 3-D solid modeling. Preferred: Knowledge of anatomy & physiology, clinical use of medical products. Preferred: Experience with catheter manufacturing and assembly methods Preferred: Knowledge of some DFX processes and tools and their application in medical device product development. Preferred: Ability to define, write and perform DOEs and test protocols for evaluating prototype performance to design criteria. **Qualifications/ Background Experiences** + Coursework toward a BS in Mechanical, Biomedical, or similar engineering discipline. + Demonstrated successful execution of a project including documentation. Academic project is acceptable. + Demonstrated successful decision making skills. Experience with performing analyses and making a recommendation. + Demonstrated analytical and logical problem solving abilities. + Demonstrated ability to distill complex technical information and explain to a much less technical audience. Experience in presenting and explaining to management. (verbal communication) + Demonstrated strong technical writing skills. (written communication) 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. Hourly rate is $20 - $24/hour