Description

Job Summary

The Process Engineer I supports the development, sustainment, and validation processes and equipment used in the manufacture of medical device product(s) including determination of process flow, fixture/tooling development, and generation of engineering and production documentation, including work instructions and process FMEAs for both internal and supplier-based processes. Also, supports cross-functional projects related to existing and new kits, as necessary, including recommended changes to specifications based on manufacturing process input. Will use a wide degree of creativity and latitude to accomplish varied and complicated tasks relying on experience and judgement to plan and accomplish goals.

Essential Job Functions

Work with production facilities and vendors to develop, evaluate, document, implement, and improve manufacturing processes throughout the product life cycle, including process control techniques, related fixtures and tooling, training personnel when required, and estimation of staffing requirements, production times, and relative costs to provide data for production decisions

Develop and maintain timelines related to project tasks throughout the process development cycle or related projects.
Act as a technical liaison between the cross-functional team and the production facilities, including vendors, for new and existing products and processes.
Implement product and process changes using the change control process.
Execute validations (IQ/OQ/PQ) in accordance with FDA and ISO harmonized standards including preparation of technical protocols, reports, and feasibility studies.
Support production transfers, including production floor layout and facility planning activities (equipment spacing, utilities, etc.).
Run laboratory equipment, i.e. environmental chamber, 3-D printers, and tensile tester. Implement appropriate preventative maintenance plans and coordinate calibration and preventative maintenance activities with Quality and Production departments.
Interface with quality and development engineers concerning critical aspects for inspection procedures and gages on new and existing products.
Create and maintain accurate documentation of process specifications, work instructions, tooling drawings, design concepts, shop orders, and concepts in accordance with the R&D and quality assurance functions.
Conduct time studies and develop standard work and routing times for processes.
Attend and contribute to team meetings in conjunction with assigned projects.

Qualifications

Bachelor of Science degree in Mechanical Engineering and minimum 1-3 years’ experience in the field or in a related area.
Technical knowledge and understanding of the medical device industry.
Computer literate with experience in Microsoft Office applications.
Intermediate level 3D and 2D computer aided design software experience required. Solidworks experience preferred.

Competencies

Demonstrates ownership and accountability; the ability to plan, execute, control, and deliver; communicate effectively both written and verbal; perform repetitive tasks; multitask and prioritize; apply knowledge and understanding of the medical industry; lead and influence others effectively and without authority.

Physical Requirements

Performing the duties of this job regularly involves sitting or standing; hearing/listening; repetitive hand movement; grasping; reaching. Performing the duties of this job may require the occasional lifting and carrying of up to 50 lbs individually and heavier items using team lifting techniques as well as bending and/or stooping. Vision requirements include the ability for close vision, the ability to adjust focus, and to color code.

Mental Requirements

This position requires the ability to maintain an appropriate work pace; comprehend and follow instructions; exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; problem solve and make decisions; analyze and interpret data; multi-task/re-direct and experience numerous interruptions. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.

Other Requirements

Minimal business travel required, less than 10% of the time (domestic and international).

Work Environment

The noise level in the work environment is usually quiet to moderate. Occasionally this position will be in a lab or machine shop environment where the noise level will be loud.

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.