Responsible for providing technical support for the day-to-day production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices. This is a hands-on position with visibility on the manufacturing floor and requires a high level of interaction with the production, product development, and quality teams. The engineer is responsible for supporting product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives.
Supports production departments’ manufacturing issues with technical support as the process expert. Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence.
Supports and drives continuous improvement activities in the manufacturing department to improve operational performance. Leads technical aspect of process validation projects
Assist product development teams with design for manufacturability requirements on new products. Supports new capital equipment and tooling purchases with appropriate documentation and evaluation
Manages multiple technically oriented projects through coordinating internal and external resources.
Collaborates on product complaint resolution.
May be asked to perform other duties as required.
Identify those items that are minimally required to perform the essential duties of the role.
These are not required to perform the basic functions of the role
Formal education (i.e. High School Diploma, Bachelor’s degree, formal certification)
Bachelor’s degree in related field
· High School Diploma with applicable experience
· Bachelor’s degree in Engineering
Type or number of years directly related work experience
· No experience required with appropriate formal education.
· 3+ years of work related to polymer processing
· Process validation (IQ, OQ, PQ)
· Equipment qualification (IQ, OQ, PQ)
Commonly known principles required for this field of work. For example, HVAC certifications, generally accepted accounting principles
· Fundamental understanding engineering principles
· Mechanical aptitude
· ISO 13485:2016
· CFR, FDA, OSHA, environmental regulations
Measurable learnings (i.e. can perform intermediate Excel and Word functions, advanced knowledge of research protocols)
· Proficiency at using Microsoft Office applications
· Troubleshooting and problem-solving skills
· Equipment / process troubleshooting
· Blue print reading
· Design of Experiments / 6 Sigma