Process Development Engineer I

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.

WORK SCHEDULE/HOURS: Adm. M-F 8:00 am - 5:00 pm

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.

• Executes in-process and product release testing.

• 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 with the guidance of managers or higher engineering levels.

• Conducts experiments, records test procedures, collects data, and documents results.

• Set up, adjust, and operate basic R&D laboratory/manufacturing equipment.

SUPERVISORY RESPONSIBILITIES:

Leadership: Yes

Supervises: Process Development Technician I and II

Supervision: 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 relevant technical engineering discipline (Required).

• 6 months -1 year of experience on related field (Required).

• B2+ English communication skills, written and oral (Required).

• Mechanical, Mechatronics, Electromechanical, Materials Engineering or any engineering related field (Preferred).

• Experience in the medical device industry and six sigma certifications (Preferred).

OTHER SKILLS and ABILITIES:

• Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet and graphics.
• Teamwork, 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.
• 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.

MANUAL DEXTERITY: Manual dexterity sufficient to reach and handle items.

VISION REQUIREMENTS: No special vision requirements