Risk Engineer II

JOB TITLE: Global Quality Risk Management - Engineer Level 3

JOB SUMMARY

The Global Quality Risk Management Engineer 3 will develop Quality Management Systems related to Risk Management and ensures alignment and appropriate integration with the company’s quality system procedures and processes.  The Risk Management Engineer 3 will play an integral role in designing and implementing quality systems to interface with multiple functional areas and product lines. Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.  The Risk Management Engineer Level 3 requires a knowledge and experience working with and owning risk procedures and files. 

ESSENTIAL DUTIES

• Responsible for the development and maintenance of Global Risk Management quality procedures and applicable quality plans in compliance with ISO 13485, ISO 14971, EU MDR, CMDR, and FDA Quality System Regulations.
• Develops and implements effective training programs related to Risk Management and Post Market Surveillance to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance.
• Works with global QMS process owners to develop and implement risk-based strategy across the company.
• Works closely with medical safety contributors to maintain the company’s Master Harms list.
• Ensures alignment of product hazard analysis for consistent decision making and actions across all functional areas and post-market activities.

• Collaborates with clinical affairs, quality, and regulatory compliance departments to ensure appropriate monitoring and feedback through post market data.
• Implements and understands FDA or regulatory requirements as necessary.
• Ensures compliance with Quality System regulations and safe working practices.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• Responsible for leadership on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Identifies project risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                  
• Handles frequent inter-organizational customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with global risk management systems.
• Presents effectively complex technical information and responds to questions from technical staff members and management.   
• Interacts with peers across projects to secure resources and commitments.
• Advises team members pro-actively on technical ideas.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Utilizes technical skills to become proficient in risk management software and teaching cross functional groups how to use the software.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering or Master of Science Degree in Engineering, preferred.

Experience

• Minimum 4 years experience.

Skills

• Expert knowledge in Risk Management and Post Market Surveillance regulatory requirements.
• Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches.

• Experience in technical innovation, technical leadership, and quality engineering.
• Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordinating with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.

• Regularly and effectively presents complex technical information and responds to questions from technical staff members and management.
• Ability to communicate effectively both verbally and in writing.

• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Understanding of and adherence to GMP practices and FDA regulations.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

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

Additional Physical Requirements

Requires travel based on business needs.

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JOB TITLE: Global Quality Risk Management - Engineer Level 3

JOB SUMMARY

The Global Quality Risk Management Engineer 3 will develop Quality Management Systems related to Risk Management and ensures alignment and appropriate integration with the company’s quality system procedures and processes.  The Risk Management Engineer 3 will play an integral role in designing and implementing quality systems to interface with multiple functional areas and product lines. Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.  The Risk Management Engineer Level 3 requires a knowledge and experience working with and owning risk procedures and files. 

ESSENTIAL DUTIES

• Responsible for the development and maintenance of Global Risk Management quality procedures and applicable quality plans in compliance with ISO 13485, ISO 14971, EU MDR, CMDR, and FDA Quality System Regulations.
• Develops and implements effective training programs related to Risk Management and Post Market Surveillance to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance.
• Works with global QMS process owners to develop and implement risk-based strategy across the company.
• Works closely with medical safety contributors to maintain the company’s Master Harms list.
• Ensures alignment of product hazard analysis for consistent decision making and actions across all functional areas and post-market activities.

• Collaborates with clinical affairs, quality, and regulatory compliance departments to ensure appropriate monitoring and feedback through post market data.
• Implements and understands FDA or regulatory requirements as necessary.
• Ensures compliance with Quality System regulations and safe working practices.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• Responsible for leadership on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Identifies project risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                  
• Handles frequent inter-organizational customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with global risk management systems.
• Presents effectively complex technical information and responds to questions from technical staff members and management.   
• Interacts with peers across projects to secure resources and commitments.
• Advises team members pro-actively on technical ideas.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Utilizes technical skills to become proficient in risk management software and teaching cross functional groups how to use the software.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.

• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering or Master of Science Degree in Engineering, preferred.

Experience

• Minimum 4 years experience.

Skills

• Expert knowledge in Risk Management and Post Market Surveillance regulatory requirements.
• Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches.

• Experience in technical innovation, technical leadership, and quality engineering.
• Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordinating with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Follows and develops technical specification requirements and provides significant input on technical procedures for various processes that impact multiple disciplines.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.

• Regularly and effectively presents complex technical information and responds to questions from technical staff members and management.
• Ability to communicate effectively both verbally and in writing.

• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Understanding of and adherence to GMP practices and FDA regulations.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

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

Additional Physical Requirements

Requires travel based on business needs.