Lumicity
Principal Process Development Engineer
Lumicity, Minneapolis, Minnesota, United States, 55400
Senior Process Development Engineer
Overview
A leading medical device manufacturer is seeking a
Senior Process Development Engineer
to advance and refine manufacturing processes. The role centers on post–design-freeze activities‑tooling, fixture design, process development, characterization, and validation (IQ/OQ/PQ) to ensure scalable, high‑quality production of precision medical devices. This position requires both technical leadership and hands‑on process engineering expertise across multi‑functional project teams.
Key Responsibilities
Develop, optimize, and validate manufacturing processes for assemblies, including reflow, bonding, molding, and reinforced shaft fabrication.
Serve as a
technical lead
on cross‑functional project teams, supporting Design Transfer and process validation activities.
Design and implement
custom tooling and fixtures
to improve operator efficiency, ergonomics, and manufacturability.
Conduct
DOE studies, statistical analysis (Cpk/Ppk), and risk assessments
to ensure robust and repeatable processes.
Partner with Product Development, Quality, and Operations teams to translate designs into stable manufacturing processes.
Prepare detailed
process development plans , defining scope, resources, and timelines for assigned programs.
Support
manufacturing readiness reviews, gate reviews, and process validation activities
(IQ/OQ/PQ/PPQ).
Drive continuous improvement efforts in yield, quality, and production efficiency.
Contribute to
engineering change control , process documentation, and compliance with regulatory and quality standards.
Mentor and train junior engineers and technicians, while maintaining a strong individual contributor focus.
Qualifications
Bachelor’s degree in Engineering or related technical discipline (advanced degree preferred).
Minimum 7+
years of experience
in process or manufacturing engineering within the
medical device industry .
Proven ability to develop and validate new manufacturing processes (IQ/OQ/PQ) in compliance with medical device quality systems.
Proficiency in
SolidWorks, Mastercam, and statistical analysis tools (e.g., Minitab) .
Strong understanding of
Design for Manufacturability (DFM) , design controls, and process validation methodologies.
Excellent communication and collaboration skills with cross‑functional teams.
Ability to manage multiple complex projects simultaneously in a fast‑paced environment.
Physical & Work Environment
Primarily office and cleanroom setting; must be able to sit or stand for extended periods.
Occasional lifting of up to 25 lbs.
Requires use of cleanroom attire and PPE as appropriate.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Manufacturing and Engineering
Medical Equipment Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
Senior Process Development Engineer
to advance and refine manufacturing processes. The role centers on post–design-freeze activities‑tooling, fixture design, process development, characterization, and validation (IQ/OQ/PQ) to ensure scalable, high‑quality production of precision medical devices. This position requires both technical leadership and hands‑on process engineering expertise across multi‑functional project teams.
Key Responsibilities
Develop, optimize, and validate manufacturing processes for assemblies, including reflow, bonding, molding, and reinforced shaft fabrication.
Serve as a
technical lead
on cross‑functional project teams, supporting Design Transfer and process validation activities.
Design and implement
custom tooling and fixtures
to improve operator efficiency, ergonomics, and manufacturability.
Conduct
DOE studies, statistical analysis (Cpk/Ppk), and risk assessments
to ensure robust and repeatable processes.
Partner with Product Development, Quality, and Operations teams to translate designs into stable manufacturing processes.
Prepare detailed
process development plans , defining scope, resources, and timelines for assigned programs.
Support
manufacturing readiness reviews, gate reviews, and process validation activities
(IQ/OQ/PQ/PPQ).
Drive continuous improvement efforts in yield, quality, and production efficiency.
Contribute to
engineering change control , process documentation, and compliance with regulatory and quality standards.
Mentor and train junior engineers and technicians, while maintaining a strong individual contributor focus.
Qualifications
Bachelor’s degree in Engineering or related technical discipline (advanced degree preferred).
Minimum 7+
years of experience
in process or manufacturing engineering within the
medical device industry .
Proven ability to develop and validate new manufacturing processes (IQ/OQ/PQ) in compliance with medical device quality systems.
Proficiency in
SolidWorks, Mastercam, and statistical analysis tools (e.g., Minitab) .
Strong understanding of
Design for Manufacturability (DFM) , design controls, and process validation methodologies.
Excellent communication and collaboration skills with cross‑functional teams.
Ability to manage multiple complex projects simultaneously in a fast‑paced environment.
Physical & Work Environment
Primarily office and cleanroom setting; must be able to sit or stand for extended periods.
Occasional lifting of up to 25 lbs.
Requires use of cleanroom attire and PPE as appropriate.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Manufacturing and Engineering
Medical Equipment Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr