Sr Manufacturing Engineer at Entegee

Summary: Seeking an experienced professional with expertise in Six Sigma, statistical analysis, process verification and validation, DFMEA/PFMEA, CAPA, and root cause investigations for medical device manufacturing.

Requirements:

• Six Sigma Certification
• Proficiency in statistical analysis tools (Minitab)
• Experience in process verification & validation, IQ/OQ/PQ, and TMV
• Knowledge of DFMEA, PFMEA, process mapping, and critical to quality reviews
• Expertise in CAPA and root cause investigation tools (DMAIC, A3, 5 Whys, 6M, Ishikawa Diagram, Pareto Charts)
• Bachelor's degree in Engineering (EE, ME, MFG, or Biomedical)
• 5+ years of experience in medical device manufacturing
• Knowledge of FDA 21 CFR part 820, ISO 13485, ISO 14971, and GMP

Preferred Skills:

• Experience with DFA/DFM, design and manufacturing documentation (specifications, procedures, sampling methods, tolerance studies, GD&T)
• Familiarity with assembly equipment technologies, molding, stamping, and machining methods

Responsibilities:

• Support in-service operating systems to ensure continued operation, maintenance, and optimization
• Determine, select, and implement technically feasible and economically viable alternatives for sustainment
• Analyze and evaluate how to improve system and equipment sustainability under continued operation, maintenance, and unexpected changes
• Develop design changes to resolve operational issues, introduce new materials, and revise product, process, and test specifications to enhance quality, integrity, reliability, and manufacturability
• Collect and evaluate service use and maintenance data; conduct root-cause analyses of in-service problems and implement corrective actions
• Utilize statistical analysis tools (Minitab, DOE, process capability, measurement system, confidence interval analysis, Six Sigma)
• Conduct process verification & validation, IQ/OQ/PQ, and TMV
• Perform DFMEA, PFMEA, process mapping, and critical to quality reviews
• Implement CAPA and root cause investigation tools (DMAIC, A3, 5 Whys, 6M, Ishikawa Diagram, Pareto Charts)

Pay Details: $50.00 to $65.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.