Principal Process Development Engineer

Job Description:

EXEMPT (Y/N): Y

DEPARTMENT: Engineering

SUPERVISOR: Engineering-Director

LAST REVIEW: JUNE, 2023

BASIS FOR KNOWLEDGE: Supervises job

SUMMARY: Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Determines direction and adequacy of designs and test results and recommends changes.  Exercises judgment within broadly defined practices and policies in selecting methods and techniques to obtain desired results.  Provides solutions to a wide range of difficult problems.  Solutions provided by the fully qualified incumbent are imaginative, thorough and practicable.  Erroneous decisions or recommendations or failure to achieve results might cause serious delays in project/program schedules and considerable expenditure and resources.  Assigning work and resolving problems may provide work leadership.  Requires a wide application of principles, theories and concepts in the functional engineering field plus a working knowledge of other related disciplines.

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

• Has full technical responsibility for interpreting, organizing, executing, and coordinating assignments.
• Plans and develops engineering projects concerned with unique or controversial problems which have an important effect on major organization programs.  This involves exploration of subject area, definition of scope and selection of problems for investigation and development of novel concepts and approaches.
• Maintains worldwide liaison with individuals and units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
• Supervision received is essentially administrative with assignments given in terms of broad general objectives and limits.
• Assignments usually include one or more of the following:

- Acts as individual technical expert, conceives or is assigned, plans, and conducts research in problem areas of considerable scope and complexity.  The problems must be approached through a series of complete and conceptually related studies, are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.  Available guides and precedent contain critical gaps, are only partially related to the problem or may be largely due to the novel character of the project.  At this level, the individual researcher generally will have contributed inventions, new designs, or techniques which are of material significance in the solution of important problems.

- Serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product).  Keeps abreast of new methods and developments affecting his/her organization for the purpose of recommending changes in emphasis of programs or new programs warranted by such development.

• Conduct engineering efforts to optimize medical component processing for manufacturing.  Typical processes including heat treatment, electropolishing and etching of nitinol.
• Participate in design and testing of tooling and fixtures for manufacturing of nitinol medical components.
• Setup and validate production lines for manufacturing. 
• Implement lean manufacturing.
• Write internal technical reports.
• Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements.

• Evaluates progress and results obtained, and recommends major changes to achieve overall objectives.  Or, as individual technical expert may technically supervise other engineers or technicians on particular projects which may be related to current major projects.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and re-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Become a SME for Nitinol processes
• Single point of contact for complex problems in Nitinol processes
• Deploy technical knowledge in Nitinol processes across the Engineering Team
• Drive Continous Improvement efforts in Nitinol processes
• Identify opportunities in terms of PvrsP
• Ensure proper equipment available as stated in the written procedures
• Assess technical capability for alternate equipment
• Challenge technical decisions being made on Nitinol processes
• Ensure learnings on Nitinol processes are timely shared/applied across transfers
• Assess PM activities for equipment being transferred
• Ensure proper tooling (hardware & software) & fixturing available for low & high runners
• Ensure proper spare parts inventory available before Ramp Up
• Ensure the most robust validation approach is provided on Nitinol processes
• Ensure technical knowledge in Nitinol processes is properly documented

SUPERVISORY RESPONSIBILITIES:  Yes

Leadership: Yes

Supervises:

• Packaging Product Development Engineer
• Production System Technician II
• Engineering Technician II
• Transfer Engineer II

EDUCATION and/or EXPERIENCE: Bachelor´s degree in relevant discipline and 8-9 years of related engineering experience. PE license is desirable beginning at this level. Has significant complex level engineering experience.  Experience in the medical device industry would be an asset.

OTHER SKILLS and ABILITIES: Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques.  Individuals at this level should be developing skills related to conflicting design requirements, unsuitability of conventional materials and difficult coordination requirements.  English communication skills, written and oral.

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

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday - Friday

TRAVEL: Minimal

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions: Moderate noise, like business office with computers and printers, light traffic.

PHYSICAL ACTIVITY LEVEL:

Sedentary physical activity performing non-strenuous daily activities of an administrative nature.

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.