BioPharma Consulting JAD Group
Manufacturing Engineer-Medical Device
BioPharma Consulting JAD Group, New York, New York, United States
The Manufacturing Engineer Contractor will support the design, validation, implementation, and optimization of manufacturing processes and equipment for ophthalmic medical devices used in cataract and vitreoretinal surgeries. This role is hands‑on and highly technical, with a strong focus on equipment validation, statistical process control, and continuous improvement in a regulated medical device manufacturing environment.
Key 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.
Required Skills & Competencies
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
Preferred Skills
Manufacturing simulation software experience (FlexSim – preferred, not required)
Education & Experience
Required:
Bachelor’s Degree in Engineering or Biomedical Engineering
Minimum of 1+ year of professional experience in a Medical Device Manufacturing environment
Preferred:
Master’s Degree in Engineering or Biomedical Engineering
12‑MONTH CONTRACT
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Key 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.
Required Skills & Competencies
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
Preferred Skills
Manufacturing simulation software experience (FlexSim – preferred, not required)
Education & Experience
Required:
Bachelor’s Degree in Engineering or Biomedical Engineering
Minimum of 1+ year of professional experience in a Medical Device Manufacturing environment
Preferred:
Master’s Degree in Engineering or Biomedical Engineering
12‑MONTH CONTRACT
#J-18808-Ljbffr