Disposables Engineer III

JOB TITLE: Engineer III

JOB SUMMARY

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include product transfer, disposables product design and development protocol development, preparation of specifications, process study, research investigations, nonconformance investigation and review, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company policies.

ESSENTIAL DUTIES

• Leads and supports transfer of products between global manufacturing locations.
• Makes changes/improvements to existing product designs and processes to resolve issues identified through complaints, manufacturing or other feedback mechanisms.
• Reviews and approves documentation that may include nonconformances, change controls, CAPAs, design reviews, verifications, as applicable.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects. This includes development of project scope and estimates, management of costs to budget, and support of final documentation in accordance with acceptable engineering practices.
• Takes initiative and demonstrates inquisitive approaches to solve complex problems, identifying problems, generating alternatives and recommending solutions. 
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Prepares and reviews engineering/technical documents such as reports, protocols, schedules and budgets, and vendor-provided documents and drawings.
• Understands product requirements in order to properly assess nonconformances and proposed changes.
• Follows technical specification requirements, developing reports, and graphs to support project recommendations.
• Working knowledge of cross-functional and related technical areas (such as Quality, Manufacturing and Regulatory).
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Handles frequent interorganizational and outside contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Ensures that processes and designs are compliant with all company policies and procedures, as well as all International, Local, State, and Federal directives, laws and regulations.

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.
• Requires frequent interaction with multiple global sites.

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 or Master of Science degree in Mechanical, Chemical, or Biomedical Engineering, preferred.

Experience

• Minimum 4 years of related experience in R&D engineering role in medical device industry
• Two years of GMP manufacturing experience, preferred.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, and problem solving.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Strong technical problem-solving skills.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices, FDA regulations and international standards.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Experience in new product introduction, process and product design, and/or manufacturing and engineering of single-use disposable medical devices. Familiar with design specifications, BOM construction, verification testing, assembly instructions, and inspection specifications
• Experience with polymers and polymer design and assembly highly preferred.
• Bilingual in English and Spanish with demonstrated ability to communicate effectively both verbally and in writing.
• Requires communication skills with various global partners from multiple cultures, including evening meetings and the potential for international travel.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Experience using CAD applications (Solidworks Preferred)
• Experience in PLM/PDM system. (Windchill Preferred)

JOB TITLE: Engineer III

JOB SUMMARY

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include product transfer, disposables product design and development protocol development, preparation of specifications, process study, research investigations, nonconformance investigation and review, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company policies.

ESSENTIAL DUTIES

• Leads and supports transfer of products between global manufacturing locations.
• Makes changes/improvements to existing product designs and processes to resolve issues identified through complaints, manufacturing or other feedback mechanisms.
• Reviews and approves documentation that may include nonconformances, change controls, CAPAs, design reviews, verifications, as applicable.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects. This includes development of project scope and estimates, management of costs to budget, and support of final documentation in accordance with acceptable engineering practices.
• Takes initiative and demonstrates inquisitive approaches to solve complex problems, identifying problems, generating alternatives and recommending solutions. 
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Prepares and reviews engineering/technical documents such as reports, protocols, schedules and budgets, and vendor-provided documents and drawings.
• Understands product requirements in order to properly assess nonconformances and proposed changes.
• Follows technical specification requirements, developing reports, and graphs to support project recommendations.
• Working knowledge of cross-functional and related technical areas (such as Quality, Manufacturing and Regulatory).
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Handles frequent interorganizational and outside contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Ensures that processes and designs are compliant with all company policies and procedures, as well as all International, Local, State, and Federal directives, laws and regulations.

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.
• Requires frequent interaction with multiple global sites.

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 or Master of Science degree in Mechanical, Chemical, or Biomedical Engineering, preferred.

Experience

• Minimum 4 years of related experience in R&D engineering role in medical device industry
• Two years of GMP manufacturing experience, preferred.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, and problem solving.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Strong technical problem-solving skills.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices, FDA regulations and international standards.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Experience in new product introduction, process and product design, and/or manufacturing and engineering of single-use disposable medical devices. Familiar with design specifications, BOM construction, verification testing, assembly instructions, and inspection specifications
• Experience with polymers and polymer design and assembly highly preferred.
• Bilingual in English and Spanish with demonstrated ability to communicate effectively both verbally and in writing.
• Requires communication skills with various global partners from multiple cultures, including evening meetings and the potential for international travel.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Experience using CAD applications (Solidworks Preferred)
• Experience in PLM/PDM system. (Windchill Preferred)

JOB TITLE: Engineer III

JOB SUMMARY

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include product transfer, disposables product design and development protocol development, preparation of specifications, process study, research investigations, nonconformance investigation and review, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company policies.

ESSENTIAL DUTIES

• Leads and supports transfer of products between global manufacturing locations.
• Makes changes/improvements to existing product designs and processes to resolve issues identified through complaints, manufacturing or other feedback mechanisms.
• Reviews and approves documentation that may include nonconformances, change controls, CAPAs, design reviews, verifications, as applicable.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects. This includes development of project scope and estimates, management of costs to budget, and support of final documentation in accordance with acceptable engineering practices.
• Takes initiative and demonstrates inquisitive approaches to solve complex problems, identifying problems, generating alternatives and recommending solutions. 
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Prepares and reviews engineering/technical documents such as reports, protocols, schedules and budgets, and vendor-provided documents and drawings.
• Understands product requirements in order to properly assess nonconformances and proposed changes.
• Follows technical specification requirements, developing reports, and graphs to support project recommendations.
• Working knowledge of cross-functional and related technical areas (such as Quality, Manufacturing and Regulatory).
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Handles frequent interorganizational and outside contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Ensures that processes and designs are compliant with all company policies and procedures, as well as all International, Local, State, and Federal directives, laws and regulations.

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.
• Requires frequent interaction with multiple global sites.

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 or Master of Science degree in Mechanical, Chemical, or Biomedical Engineering, preferred.

Experience

• Minimum 4 years of related experience in R&D engineering role in medical device industry
• Two years of GMP manufacturing experience, preferred.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, and problem solving.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Strong technical problem-solving skills.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices, FDA regulations and international standards.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Experience in new product introduction, process and product design, and/or manufacturing and engineering of single-use disposable medical devices. Familiar with design specifications, BOM construction, verification testing, assembly instructions, and inspection specifications
• Experience with polymers and polymer design and assembly highly preferred.
• Bilingual in English and Spanish with demonstrated ability to communicate effectively both verbally and in writing.
• Requires communication skills with various global partners from multiple cultures, including evening meetings and the potential for international travel.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Experience using CAD applications (Solidworks Preferred)
• Experience in PLM/PDM system. (Windchill Preferred)