Sr. Principal Systems Engineer
AngioDynamics

Job Info

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JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE

It takes a team of talented people to become one of the world's leading providers of innovative medical devices.

AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.

We accomplish this through:

• A Commitment to the Highest Standards of Quality
• Relentless Innovation
• Operational Excellence

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new and sustaining product development efforts within the R&D organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include managing internal and external hardware and software development, identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.

Extensive knowledge of medical device design control requirements, system design, software, hardware, integration testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.

Essential Duties and Responsibilities

• Manage the internal and external Hardware and Software resources for capital programs, including task prioritization, budgeting, and spending.
• Ensure corporate infrastructure/business tools are sufficient to support the needs of development teams.
• Provide project and technical leadership to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
• Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
• Work closely with Marketing in collection of user needs/feedback on product requirements and concepts
• Lead the requirements development and management process, incorporating risk management elements as required.
• Ensure compliance to product security and cyber security policies, and support efforts to author local SOP's to ensure compliance.
• Support the optimization of design control elements to comply with medical device regulations.
• Implement product design with the intention of optimizing design for manufacturability and testability.
• Consider Cost of Goods and lifecycle when selecting components for device designs.
• Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
• Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
• Provide support of Risk Management activities, working with Design Assurance.
• Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities.
• Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.
• Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.
• Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.
• Support DA in ensuring software SOPs are aligned with regulations and current best-practice.
• Assist in the development of less-experienced staff.
• May perform other duties as assigned

Supervisory Responsibilities No

Regulatory Responsibilities

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

Individual Contributor

Build Quality into all aspects of their work by maintaining compliance to all quality requirements

QUALIFICATIONS-The requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience

• BSSE
• Equivalent work related experience acceptable in lieu of degree:
• 12
• Experience with robust software life-cycle procedures, version control systems, bug tracking, and configuration management.
• N/A
• 10 years of Medical Device experience, advanced degree, preferably in MSCS (Computer Science), Information Systems or related field, or MSME or MSEE.

Skills/Knowledge

• Thorough knowledge of object-oriented programming and design, multi-tier software development, and component architectures.
• Strong trouble-shooting skills.
• Strong hands-on knowledge of product development methodologies and practice.
• Independent and detail-oriented.

• :
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.

PHYSICAL/WORK REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
• standard office environment
• 50ilbs.
• sit or stand for extended periods of time

This position requires some travel up to 10% of the time

The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new and sustaining product development efforts within the R&D organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include managing internal and external hardware and software development, identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.

Extensive knowledge of medical device design control requirements, system design, software, hardware, integration testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.

Essential Duties and Responsibilities

• Manage the internal and external Hardware and Software resources for capital programs, including task prioritization, budgeting, and spending.
• Ensure corporate infrastructure/business tools are sufficient to support the needs of development teams.
• Provide project and technical leadership to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
• Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
• Work closely with Marketing in collection of user needs/feedback on product requirements and concepts
• Lead the requirements development and management process, incorporating risk management elements as required.
• Ensure compliance to product security and cyber security policies, and support efforts to author local SOP's to ensure compliance.
• Support the optimization of design control elements to comply with medical device regulations.
• Implement product design with the intention of optimizing design for manufacturability and testability.
• Consider Cost of Goods and lifecycle when selecting components for device designs.
• Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
• Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
• Provide support of Risk Management activities, working with Design Assurance.
• Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities.
• Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.
• Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.
• Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.
• Support DA in ensuring software SOPs are aligned with regulations and current best-practice.
• Assist in the development of less-experienced staff.
• May perform other duties as assigned

Supervisory Responsibilities No

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

Individual Contributor

Build Quality into all aspects of their work by maintaining compliance to all quality requirements

QUALIFICATIONS-The requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience

• BSSE
• Equivalent work related experience acceptable in lieu of degree:
• 12
• Experience with robust software life-cycle procedures, version control systems, bug tracking, and configuration management.
• N/A
• 10 years of Medical Device experience, advanced degree, preferably in MSCS (Computer Science), Information Systems or related field, or MSME or MSEE.

Skills/Knowledge

• Thorough knowledge of object-oriented programming and design, multi-tier software development, and component architectures.
• Strong trouble-shooting skills.
• Strong hands-on knowledge of product development methodologies and practice.
• Independent and detail-oriented.
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.

PHYSICAL/WORK REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
• Sit or stand for extended periods of time

This position requires some travel up to 10% of the time

This job has expired.