Process Development Engineer Senior Staff

at  Confluent Medical Technologies

Job Description:
SUMMARY: Works on product development projects where analysis of situations and prioritization of tasks are key factors in the job performance. Responsible for all aspects of process development; from development, optimization to validation and production. Exercises judgment within defined procedures and practices to determine appropriate action. Demonstrates full use and application of standard principles, project management tools, theories, concepts and techniques. Participates in decision on scope of work, selection of equipment’s, length of tasks and team members required. Must be able to accomplish broad and complex assignments. Provides technical guidance to lower level personnel.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Responsible for process development – from proof-of-concept prototypes to sustained manufacturing validation - planning, and coordinating engineering activities, studies and programs in support of standard production and new product development.
• Process development and implementation in diverse Engineering fields, product selection, evaluation, and capability testing, along with developing and selecting other equipment and tooling, reviewing and evaluating for overall effectiveness.
• Support and provide equipment guidelines and tooling modifications for process improvements.
• Resolve process issues by analyzing data; identify root causes and recommending actions.
• Develop strategic processing goals and objectives and integrate processes into value streams. Executes in-process and product release testing.
• Request capital appropriation based on sound testing and demonstrated feasibility.
• Work in collaboration with operators, technicians, and other process engineers to deliver devices that meet customer requirements.
• Coordinate with production team for training and manufacturing of devices.
• May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
• Independently performs most assignments with instructions as to the general results expected.
• Practice company safety, quality policies and procedures, actively requires conformance.
• Responsible for performing manufacturing reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Properly document activities in accordance with the best engineering practices, company procedures, and regulatory requirements.
• Write internal technical reports without supervision.
• Conducts experiments, records test procedures, collects data, and documents results in a lab notebook.
• Sets up, adjust, and operate basic R&D laboratory/manufacturing equipment.

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in engineering discipline.
• Strong understanding of Medical Device manufacture, plus 6-8 years of experience related to engineering roles such as NPI, Process transfers, Manufacturing engineering or similar roles.Green Belt basis and/or certification is required. Black Belt is an asset.
• Advanced english communication skills, written and oral

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: Yes
Leadership: N/A

Supervises:

• Process Development Technician I and II

Supervision:
Direction: receive guidance with respect to general objectives; in the majority of tasks and projects assigned, determine methods, work sequence, scheduling, and how to achieve objectives of assignments; operate within specific policy guidelines.

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in engineering discipline.
• Strong understanding of Medical Device manufacture, plus 6-8 years of experience related to engineering roles such as NPI, Process transfers, Manufacturing engineering or similar roles.Green Belt basis and/or certification is required. Black Belt is an asset.
• Advanced english communication skills, written and oral.

OTHER SKILLS and ABILITIES: Team work, ability to work with low supervision, learns quickly and independently in the context of industrial or technical activities; seeks opportunities to extend and deepen learning.
Have significant engineering understanding and knowledge of basic project management theoretical fundamentals. Individuals at this level should be developing skills related to problem solving methodology, group leadership and difficult coordination requirements. English communication skills, written and oral.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Statistical knowledge is required. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Responsible for process development – from proof-of-concept prototypes to sustained manufacturing validation - planning, and coordinating engineering activities, studies and programs in support of standard production and new product development.
• Process development and implementation in diverse Engineering fields, product selection, evaluation, and capability testing, along with developing and selecting other equipment and tooling, reviewing and evaluating for overall effectiveness.
• Support and provide equipment guidelines and tooling modifications for process improvements.
• Resolve process issues by analyzing data; identify root causes and recommending actions.
• Develop strategic processing goals and objectives and integrate processes into value streams. Executes in-process and product release testing.
• Request capital appropriation based on sound testing and demonstrated feasibility.
• Work in collaboration with operators, technicians, and other process engineers to deliver devices that meet customer requirements.
• Coordinate with production team for training and manufacturing of devices.
• May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
• Independently performs most assignments with instructions as to the general results expected.
• Practice company safety, quality policies and procedures, actively requires conformance.
• Responsible for performing manufacturing reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Properly document activities in accordance with the best engineering practices, company procedures, and regulatory requirements.
• Write internal technical reports without supervision.
• Conducts experiments, records test procedures, collects data, and documents results in a lab notebook.
• Sets up, adjust, and operate basic R&D laboratory/manufacturing equipment