Manufacturing Engineer-Medical Device jobs in United States
cer-icon
Apply on Employer Site
company-logo

BioPharma Consulting JAD Group ยท 1 day ago

Manufacturing Engineer-Medical Device

positionHouston, TX
timeContract
remoteOnsite
seniorityEntry Level
date1+ years exp

BioPharma Consulting JAD Group is seeking a Manufacturing Engineer Contractor to support the design, validation, implementation, and optimization of manufacturing processes for ophthalmic medical devices. This hands-on role focuses on equipment validation, statistical process control, and continuous improvement in a regulated medical device manufacturing environment.

ConsultingTherapeutics
check
H1B Sponsor Likelynote

Responsibilities

Lead, execute, document, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi-automated production equipment and processes
Design, develop, validate, and implement manufacturing processes for ophthalmic medical devices
Provide hands-on engineering support for manufacturing equipment before, during, and after release to production
Apply Lean Manufacturing and Six Sigma methodologies to optimize production processes
Implement Continuous Monitoring using Statistical Process Control (SPC) to maintain equipment and processes in a validated state
Perform continuous statistical analysis of Critical Quality Attributes (CQAs) and process indicators to ensure compliance with product specifications (CpK / process capability)
Design fixtures and create technical drawings using CAD software (e.g., SolidWorks) to support daily production operations
Develop and maintain standard work instructions and procedures to ensure robust and high-quality manufacturing processes
Promote cross-functional collaboration through clear communication and effective coordination with all departments

Qualification

Medical Device ValidationStatistical Process ControlStatistical AnalysisCAD design (SolidWorks)Proficiency with MinitabPublic speakingLean ManufacturingSix SigmaManufacturing simulation softwareTechnical writingCommunication skills

Required

Medical Device Validation (IQ, OQ, PQ)
Statistical Process Control (SPC)
Statistical Analysis techniques including: DOE, ANOVA, Gage R&R, T-Test, Tolerance Interval Analysis, Control Charts, Process Capability (CpK)
Proficiency with statistical software (Minitab)
CAD design experience (SolidWorks or equivalent)
Strong technical writing skills
Effective public speaking and communication skills
Bachelor's Degree in Engineering or Biomedical Engineering
Minimum of 1+ year of professional experience in a Medical Device Manufacturing environment

Preferred

Manufacturing simulation software experience (FlexSim - preferred, not required)
Master's Degree in Engineering or Biomedical Engineering

Benefits

12-MONTH CONTRACT

Company

BioPharma Consulting JAD Group

twittertwitter
company-logo
BioPharma Consulting JAD Group is a consulting company that provides solutions in the validation, engineering, and compliance fields.
dateFounded in 2010
location
Cambridge, Massachusetts, USA
people-size51-200 employees
web-link
http://bpc-jadgroup.com/

H1B Sponsorship

BioPharma Consulting JAD Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)

Funding

Current Stage
Growth Stage

Leadership Team

D
Diego Ramirez
Owner
linkedin
Company data provided by crunchbase