Exciting Engineering Opportunity!
Principal Engineer – Injectables - Medical Device
Come join this well-established Fortune 500 Company as they continue to lead the Medical Device industry in technology, manufacturing, Engineering and Design.
Essential Duties and Responsibilities:
- Lead cross functional teams to design, develop, install, and qualify new technologies (e.g., machine vision systems) within Companies solution container manufacturing process to improve product quality.
- Utilize engineering tools (e.g., DMAIC, FMEA, Design of Experiments, Statistical Analysis, etc.) in support of continuous improvement initiatives related to manufacturing processes at domestic and global locations.
- Lead projects within Companies change control management (CCM) process, from initiation through closure.
Typical change control projects include:
Qualification of supplier changes (SNC), quality and value improvements (VIP), manufacturing issue resolution, and new equipment qualification. Change Owners must assign and prepare impact assessments, develop change plans, write and execute engineering studies, develop detailed project schedules, while working closely with manufacturing plants, Quality, Regulatory, supplier, and various scientific/ technical groups. Communicate project and task status to project team members, management, and stakeholders on a regular basis.
- Generate technical documentation in support of project deliverables and requirements, such as protocols, reports, and change control supporting documents.
- Develop and manage technical project schedules based on interface with development and technical support groups, to meet deliverables and commitments.
- Challenge ideas, philosophies, colleagues and status quo to lead an environment of continuous improvement.
- Ability to influence decisions that focus on value and balance technical risk and overall cost to the business.
- May supervise contractors, interns, and/or engineers that are part of the Company development program (e.g, TDP, ODP, etc.).
- Bachelor’s Degree in Engineering and 5-8 years related experience.
- Must have manufacturing experience in a regulated industry (experience with small or large volume injectable's, plastics and/or elastomeric products – a plus!)
- A preference will be given to candidates who have experience designing, developing, and/or commissioning new equipment or processes in a manufacturing environment (vision system experience – a plus!).
- Must be able to present and communicate results and recommendations to project teams and decision makers in both written and verbal form.
- Must be able to effectively operate within, and facilitate, cross functional teams, with minimal guidance.
- Must be able and willing to travel domestically and globally (up to 30% travel).
Please contact Kevin Elliott for more details. (817) 857-7713 firstname.lastname@example.org