Career

•  Provide technical leadership for the design and development of medical devices
• Assist in the transfer of new products from R&D to production
• Establish processes and manufacturing documentation for new catheter products
• Identify processes to fabricate new products
• Use CAD softwares (Solidworks preferred and Autocad) for part and assembly design and detail drawings
• Perform experiments to determine validity of designs
• Provide technical leadership for development projects
• Define product requirements
• Design and development of tooling
• Perform or manage design verification, equipment qualification and product and process validations
• Prepare and maintain product documentation including DXF, drawings, BOM, test protocols and reports, etc.
• Supervise and advise team members as necessary
• Comply with applicable FDA and international regulatory laws/standards
• Other duties as assigned or required

• Master’s Degree in mechanical or biomedical engineering or equivalent experience.
• Five (5) years industry experience with a medical device, pharmaceutical, biotechnology company
• Two (2) years supervisory experience
• Knowledge FDA/MDD regulations as they relate to Class III medical devices.
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Prior experience with non-invasive medical devices in advanced catheters.
• Prior experience with a start-up medical device company
• Ability to present and teach detailed technical information, to all levels of company personnel and customers.

• MS. in Biomedical Engineering and MBA, or equivalent combination of 4-year and graduate degrees in Engineering, Natural and Life Sciences and Business
• 5 years of experience in Medical Devices, Diagnostic or Life Science industries with at least 3 years of Upstream Product Marketing and/or Product Management
• Solid understanding of human cardiovascular anatomy, physiology, clinical practice, and clinical science; the understanding of cardiac electrophysiology and electrophysiology devices is highly required
• Demonstrate ability to drive medical product development from concept to product realization in a variety of technical areas, including capital hardware and software, implantable medical devices, disposable interventional devices (such as catheters), or similar; solid understanding of VOC practices and FDA/CE quality management system requirements is a must
• Practical understanding of commercialization processes in different geographies and is highly desirable; professional experience in customer-facing roles such as Downstream Marketing, Field Clinical Engineering or Sales is a significant plus
• Strong technical verbal and written communication skills; demonstrated experience in medical writing on both professional and consumer levels is desirable
• Strong cross-functional leadership in fast-paced environment, comfort under conditions of uncertainty, strong analytical and financial acumen combined with bias for action
• Demonstrated experience handling multiple cross-functional projects; project management certification is a definite plus

• Provide technical leadership for the design and development of medical devices
• Review, update, and ensure team adherence to manufacturing process instruction, production travelers, and manufacturing methods.
• Identify opportunities for improvements to process equipment, fixtures, and workspaces
• Track production orders, build progress, yield data, and provide clear and accurate updates for management
• Supports preventive maintenance and calibration of production equipment
• Maintains product and company reputation by complying with regulations
• Provides support for new product development and manufacturing
• Experience with and use of ERP systems
• Support product orders and shipping.
• Comply with applicable FDA and international regulatory laws/standards
• Other duties as assigned or required
• Other duties as assigned or required

• Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience.
• Five (5) years industry experience with a medical device, pharmaceutical, biotechnology company
• Two (2) years supervisory experience
• Knowledge FDA/MDD regulations as they relate to Class III medical devices.
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Work closely with equipment and service vendors
• Good time and project management skills, good prioritization, and communication skills.
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Prior experience with non-invasive medical devices in advanced catheters.
• Prior experience with a start-up medical device company
• Ability to present and teach detailed technical information, to all levels of company personnel and customers.

• BS. in Biomedical Engineering and MBA, or equivalent combination of 3-year and graduate degrees in Engineering, Natural and Life Sciences and Business
• 5 years of experience in Medical Devices, Diagnostic or Life Science industries with at least 3 years of Upstream Product Marketing and/or Product Management
• Solid understanding of human cardiovascular anatomy, physiology, clinical practice, and clinical science; the understanding of cardiac electrophysiology and electrophysiology devices is highly required
• Demonstrate ability to drive medical product development from concept to product realization in a variety of technical areas, including capital hardware and software, implantable medical devices, disposable interventional devices (such as catheters), or similar; solid understanding of VOC practices and FDA/CE quality management system requirements is a must
• Practical understanding of commercialization processes in different geographies and is highly desirable; professional experience in customer-facing roles such as Downstream Marketing, Field Clinical Engineering or Sales is a significant plus
• Strong technical verbal and written communication skills; demonstrated experience in medical writing on both professional and consumer levels is desirable
• Strong cross-functional leadership in fast-paced environment, comfort under conditions of uncertainty, strong analytical and financial acumen combined with bias for action
• Demonstrated experience handling multiple cross-functional projects; project management certification is a definite plus

Apply

Job Title: Principal Process Development Engineer

Department: Operations Engineering  in Advanced Electrophysilogical Catheters

Reporting To: Chief Technical Officer (CTO)

This position will report directly to the CTO. MEDUS AG specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

Job Summary

MEDUS AG is a leading research and development innovative catheters in treatment of cardiac arrhythmias by developing catheter mapping and ablation technologies.

The Principal Process Development Engineer position at MEDUS AG is an engineering professional with 5+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for providing guidance and oversight to multiple teams or individuals working on numerous products or developing various forms of medical device technologies. This individual is a leader who thinks strategically and has long-range company goals in mind and will manage all phases of technical projects. They will oversee the product or project conception, product design, product design documentation and manage scheduling, estimating and securing materials and vendors. The Principal Process Development Engineer will also conduct engineering studies and investigations and prepare reports for company leadership. They also provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.

Key Job Duties and Responsibilities:

• Provide technical leadership for the design and development of medical devices
• Assist in the transfer of new products from R&D to production
• Establish processes and manufacturing documentation for new catheter products
• Identify processes to fabricate new products
• Use CAD softwares (Solidworks preferred and Autocad) for part and assembly design and detail drawings
• Perform experiments to determine validity of designs
• Provide technical leadership for development projects
• Define product requirements
• Design and development of tooling
• Perform or manage design verification, equipment qualification and product and process validations
• Prepare and maintain product documentation including DXF, drawings, BOM, test protocols and reports, etc.
• Supervise and advise team members as necessary
• Comply with applicable FDA and international regulatory laws/standards
• Other duties as assigned or required

Additional Requirements:

• Master’s Degree in mechanical or biomedical engineering or equivalent experience.
• Five (5) years industry experience with a medical device, pharmaceutical, biotechnology company
• Two (2) years supervisory experience
• Knowledge FDA/MDD regulations as they relate to Class III medical devices.
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Prior experience with non-invasive medical devices in advanced catheters.
• Prior experience with a start-up medical device company
• Ability to present and teach detailed technical information, to all levels of company personnel and customers.

Personal and Experiences Qualifications:

• MS. in Biomedical Engineering and MBA, or equivalent combination of 4-year and graduate degrees in Engineering, Natural and Life Sciences and Business
• 5 years of experience in Medical Devices, Diagnostic or Life Science industries with at least 3 years of Upstream Product Marketing and/or Product Management
• Solid understanding of human cardiovascular anatomy, physiology, clinical practice, and clinical science; the understanding of cardiac electrophysiology and electrophysiology devices is highly required
• Demonstrate ability to drive medical product development from concept to product realization in a variety of technical areas, including capital hardware and software, implantable medical devices, disposable interventional devices (such as catheters), or similar; solid understanding of VOC practices and FDA/CE quality management system requirements is a must
• Practical understanding of commercialization processes in different geographies and is highly desirable; professional experience in customer-facing roles such as Downstream Marketing, Field Clinical Engineering or Sales is a significant plus
• Strong technical verbal and written communication skills; demonstrated experience in medical writing on both professional and consumer levels is desirable
• Strong cross-functional leadership in fast-paced environment, comfort under conditions of uncertainty, strong analytical and financial acumen combined with bias for action
• Demonstrated experience handling multiple cross-functional projects; project management certification is a definite plus

Apply
Job Title: R&D Product Development Engineer

Department: R&D Product Development Engineer in Advanced Electrophysilogical Catheters

Reporting To: Chief Technical Officer (CTO)

This position will report directly to the CTO. MEDUS AG specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

Job Summary

MEDUS AG is a leading research and development innovative catheters in treatment of cardiac arrhythmias by developing catheter mapping and ablation technologies.

The primary role of the R&D Product Development Engineer is to provide catheter prototyping and device assembly support to the engineering team. The R&D Product Development Engineer periodically conducts verification testing to assess the functionality of catheter prototypes. The R&D Product Development Engineer trains production assembly team members for production of new catheter designs. The ideal candidate is a seasoned expert production assembler ready to move from the medical device production environment into the R&D department.

The R&D Product Development Engineerposition at MEDUS AG is an engineering professional with 5+ years of experience in the medical device industry or other regulated industry. The qualified candidate will be responsible for providing guidance and oversight to multiple teams or individuals working on numerous products or developing various forms of medical device technologies. This individual is a leader who thinks strategically and has long-range company goals in mind and will manage all phases of technical projects. They will oversee the product or project conception, product design, product design documentation and manage scheduling, estimating and securing materials and vendors. The R&D Product Development Engineer will also conduct engineering studies and investigations and prepare reports for company leadership. They also provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.

Key Job Duties and Responsibilities:

• Provide technical leadership for the design and development of medical devices
• Proficient with catheter manufacturing tools and practices (hot torches, adhesives, shrink tubing, tubing cutters etc.)
• Strong problem solving skills, independent thinker, and attention to detail
• Comfortable working with small parts and sub-assemblies by using templates or measurements
• Assemble/fabricate components, examine/evaluate connections for fit
• Verify specifications by measuring completed components
• Resolve assembly problems, and communicate all problems with R&D engineering
• Keeps equipment operational by ensuring all have the proper asset and calibration labels
• Maintain a safe and clean working environment by complying with company procedures, rules, and regulations
• Maintain lab supply inventory by checking stock periodically to determine inventory level; anticipating needed supplies; communicates need to appropriate personnel
• Documents all actions by completing R&D production and quality forms
• Build prototypes for feasibility testing, animal studies and pilot manufacturing builds
• Assist in the transfer of new products from R&D to production
• Establish processes and manufacturing documentation for new catheter products
• Identify processes to fabricate new products
• Use CAD softwares (Solidworks preferred and Autocad) for part and assembly design and detail drawings
• Perform experiments to determine validity of designs
• Provide technical leadership for development projects
• Define product requirements
• Design and development of tooling
• Perform or manage design verification, equipment qualification and product and process validations
• Prepare and maintain product documentation including DXF, drawings, BOM, test protocols and reports, etc.
• Supervise and advise team members as necessary
• Comply with applicable FDA and international regulatory laws/standards
• Other duties as assigned or required

Additional Requirements:

• Master’s Degree in mechanical or biomedical engineering or equivalent experience.
• Five (5) years industry experience with a medical device, pharmaceutical, biotechnology company
• Two (2) years supervisory experience
• Knowledge FDA/MDD regulations as they relate to Class III medical devices.
• Demonstration of excellent communication (written and oral) skills
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
• Prior experience with non-invasive medical devices in advanced catheters.
• Prior experience with a start-up medical device company
• Ability to present and teach detailed technical information, to all levels of company personnel and customers.

Personal and Experiences Qualifications:

• MS. in Biomedical Engineering and MBA, or equivalent combination of 4-year and graduate degrees in Engineering, Natural and Life Sciences and Business
• 5 years of experience in Medical Devices, Diagnostic or Life Science industries with at least 3 years of Upstream Product Marketing and/or Product Management
• Solid understanding of human cardiovascular anatomy, physiology, clinical practice, and clinical science; the understanding of cardiac electrophysiology and electrophysiology devices is highly required
• Demonstrate ability to drive medical product development from concept to product realization in a variety of technical areas, including capital hardware and software, implantable medical devices, disposable interventional devices (such as catheters), or similar; solid understanding of VOC practices and FDA/CE quality management system requirements is a must
• Practical understanding of commercialization processes in different geographies and is highly desirable; professional experience in customer-facing roles such as Downstream Marketing, Field Clinical Engineering or Sales is a significant plus
• Strong technical verbal and written communication skills; demonstrated experience in medical writing on both professional and consumer levels is desirable
• Strong cross-functional leadership in fast-paced environment, comfort under conditions of uncertainty, strong analytical and financial acumen combined with bias for action
• Demonstrated experience handling multiple cross-functional projects; project management certification is a definite plus

Apply

Job Title: Catheter Assembler

Department: Operations in Advanced Electrophysilogical Catheters Assembling

Reporting To: Production Manager

This position will report directly to the Production Manager.

Job Summary

MEDUS AG is a leading research and development innovative catheters in treatment of cardiac arrhythmias by developing catheter mapping and ablation technologies.

The primary responsibility of the Catheter Assembler is to perform assembly line tasks as well as identify areas of improvement to increase efficiency.

Key Job Duties and Responsibilities:

• Proficient with catheter manufacturing tools and practices (hot torches, adhesives, shrink tubing, tubing cutters etc.)
• Strong problem solving skills, independent thinker, and attention to detail
• Comfortable working with small parts and sub-assemblies by using templates or measurements
• Assemble/fabricate components, examine/evaluate connections for fit
• Verify specifications by measuring completed components
• Resolve assembly problems, and communicate all problems with R&D engineering
• Keeps equipment operational by ensuring all have the proper asset and calibration labels
• Maintain a safe and clean working environment by complying with company procedures, rules, and regulations
• Maintain lab supply inventory by checking stock periodically to determine inventory level; anticipating needed supplies; communicates need to appropriate personnel
• Assembles, repairs, inspect and/or test products following written instructions.
• Work with a team to assemble entire products or components
• Rotate through tasks for specific production processes
• Conduct quality inspections on products and parts
• Prepare finished products for shipment
• Maintain a clean and orderly work area
• Set up and operates a variety of machines following written instructions
• Record information on approved documents.
• Train other employees when necessary
• Reads and interprets documents associated with the completion of assembly assignments. Utilizes knowledge of basic math, drawings.

Personal and Experiences Qualifications Requirements:

• H.S. diploma or equivalent plus 2-5 years of related work experience or equivalent combination of education and work experience
• Previous experience in manufacturing, assembly, or other related fields
• Familiarity with assembly tools and equipment
• Ability to handle physical workload
• Ability to work well in teams
• Ability to thrive in a fast-paced environment
• Clean room experience and application of environmental procedures experience
• Working knowledge of QSR and GMP

Apply

Job Title: Catheter Assembler

Department: Operations in Advanced Electrophysilogical Catheters Assembling

Reporting To: Production Manager

This position will report directly to the Production Manager.

Job Summary

MEDUS AG is a leading research and development innovative catheters in treatment of cardiac arrhythmias by developing catheter mapping and ablation technologies.

The primary responsibility of the Catheter Assembler is to perform assembly line tasks as well as identify areas of improvement to increase efficiency.

Key Job Duties and Responsibilities:

• Proficient with catheter manufacturing tools and practices (hot torches, adhesives, shrink tubing, tubing cutters etc.)
• Strong problem solving skills, independent thinker, and attention to detail
• Comfortable working with small parts and sub-assemblies by using templates or measurements
• Assemble/fabricate components, examine/evaluate connections for fit
• Verify specifications by measuring completed components
• Resolve assembly problems, and communicate all problems with R&D engineering
• Keeps equipment operational by ensuring all have the proper asset and calibration labels
• Maintain a safe and clean working environment by complying with company procedures, rules, and regulations
• Maintain lab supply inventory by checking stock periodically to determine inventory level; anticipating needed supplies; communicates need to appropriate personnel
• Assembles, repairs, inspect and/or test products following written instructions.
• Work with a team to assemble entire products or components
• Rotate through tasks for specific production processes
• Conduct quality inspections on products and parts
• Prepare finished products for shipment
• Maintain a clean and orderly work area
• Set up and operates a variety of machines following written instructions
• Record information on approved documents.
• Train other employees when necessary
• Reads and interprets documents associated with the completion of assembly assignments. Utilizes knowledge of basic math, drawings.

Personal and Experiences Qualifications Requirements:

• H.S. diploma or equivalent plus 2-5 years of related work experience or equivalent combination of education and work experience
• Previous experience in manufacturing, assembly, or other related fields
• Familiarity with assembly tools and equipment
• Ability to handle physical workload
• Ability to work well in teams
• Ability to thrive in a fast-paced environment
• Clean room experience and application of environmental procedures experience
• Working knowledge of QSR and GMP