Manufacturing Engineer II
Description
Manufacturing Engineer will support the introduction of
new products and manufacturing processes within a regulated medical device
environment. The role focuses on equipment validation, process development, and
ensuring manufacturing processes comply with regulatory and quality
requirements. The engineer will work closely with cross-functional teams to
support equipment qualification, process validation activities, and production
line implementation.
Responsibilities:
- Design
and develop manufacturing processes, procedures, and production layouts
for assemblies, equipment installation, and material handling.
- Support new product introduction (NPI) activities including process
development and validation.
- Execute equipment qualification activities (IQ/OQ/PQ) and support process
validation lifecycle.
- Develop
and execute validation protocols and reports for manufacturing
equipment and processes.
- Support process characterization, operational qualification, and performance
qualification activities.
- Develop
and update Standard Operating Procedures (SOPs) and manufacturing
documentation.
- Support change control processes in compliance with medical device
regulations.
- Assist
in statistical analysis and design of experiments (DOE) using tools
such as Minitab.
- Provide line support during special builds and production activities.
- Investigate
manufacturing issues, implement corrective actions, and ensure product
quality.
- Collaborate
with engineering teams to optimize manufacturing processes and equipment
utilization.
- Ensure
manufacturing processes comply with regulatory and quality system
requirements.
*Other duties may be assigned*
Requirements
Minimum 3 to10 years of relevant engineering experience in manufacturing, validation, or process engineering within a regulated
industry.
Bachelor’s Degree in Engineering completed.
Top 3 Candidate Experience Requirements:
- Equipment
Qualification (IQ) experience
- OQ
/ PQ or Process Validation experience
- Process
Validation Lifecycle knowledge (Process Characterization → OQ → PQ)
- DOE
(preferred using Minitab)
Technical Skills (Must Have):
- Experience
performing Equipment Qualification (IQ).
- Experience
with Operational Qualification (OQ) and Performance
Qualification (PQ).
- Knowledge
of the Process Validation Lifecycle (process characterization → OQ
→ PQ).
- Experience
supporting process validation within a regulated environment.
Preferred Technical Skills:
- Experience
with Design of Experiments (DOE) using Minitab.
- Experience
with Injection Molding Processes.
- Experience
in Process Development and Documentation.
- Experience
with Equipment Validation.
- Experience
supporting Special Builds and Manufacturing Line Support.
Additional Skills:
- Computer
System Validation (CSV)
- SOP
Development
- Change
Control in Medical Devices
- Experience
with MES systems
- Documentation
management within regulated industries