Production Engineer

Responsible for providing technical support for the day-today 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.

40%
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.

25%
Supports and drives continuous improvement activities in the
manufacturing department to improve operational performance. Leads
technical aspect of process validation projects per QIENG-00022.

15%
Assist product development teams with design for manufacturability
requirements on new products. Supports new capital equipment and
tooling purchases with appropriate documentation and evaluation in
accordance with QIENG-00016 and QIENG-00017.

5%
Manages multiple technically oriented projects through coordinating
internal and external resources.
Varying* Collaborates on product complaint resolution.
Varying May be asked to perform other duties as required.

Experience

Minimum - No experience required
with appropriate formal
education.

Preferred -

• 3+ years of work
  related to polymer
  processing
• Process validation
  (IQ, OQ, PQ)
•  Equipment
  qualification (IQ,
  OQ, PQ)

Knowledge -

• Fundamental
  understanding engineering
  principles
• Mechanical
  aptitude
• ISO 13485:2016
• CFR, FDA, OSHA,
  environmental
  regulations

Skills -

• Proficiency at using
  Microsoft Office
  applications
• Troubleshooting and
  problem-solving skills
• Equipment /
  process
  troubleshooting
• Blue print reading
• Design of
  Experiments / 6
  Sigma