Senior Process Engineer (Process Development)
Job Description Job
Summary:
We are looking for a high-performing individual that will drive the development of medical device manufacturing processes from prototype assembly to production manufacturing.
Duties and Responsibilities include, but are not limited to:
Responsible for improvement, optimization, and implementation of manufacturing process/assembly and operating procedures for replicate equipment and processes within a regulated quality system.
Lead and support equipment/process qualifications including protocol development and execution.
Develop and maintain project timelines and provide updates and feedback to management.
Development of production test systems and test plans in accordance with regulatory standards.
Plan and perform design of experiments and utilize Lean/Six Sigma methodologies for improved and new processes.
Sensor data analysis-perform statistically robust analysis of data and report on findings.
Support activities for regulatory submissions and quality compliance.
Knowledge, Skills, Abilities and Requirements:
BS degree (minimum) or higher (MS or Ph.
D.
preferred) in the Engineering Sciences (ie, Chemical, Mechanical, Electrical, Physics, etc.
) Minimum 5
years' experience in a regulated medical manufacturing environment (7+years preferred) Knowledge of production unit operations and test systems Failure mode effects analysis experience for root cause analysis Six Sigma/Lean principles experience (green belt, with black belt preferred) Proficient in minitab and Microsoft office suite Direct experience with regulated environments (ie, ISO 13485, 21 CFR 820, Notified Bodies, GMP, OSHA, EPA) required.
Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
We are looking for a high-performing individual that will drive the development of medical device manufacturing processes from prototype assembly to production manufacturing.
Duties and Responsibilities include, but are not limited to:
Responsible for improvement, optimization, and implementation of manufacturing process/assembly and operating procedures for replicate equipment and processes within a regulated quality system.
Lead and support equipment/process qualifications including protocol development and execution.
Develop and maintain project timelines and provide updates and feedback to management.
Development of production test systems and test plans in accordance with regulatory standards.
Plan and perform design of experiments and utilize Lean/Six Sigma methodologies for improved and new processes.
Sensor data analysis-perform statistically robust analysis of data and report on findings.
Support activities for regulatory submissions and quality compliance.
Knowledge, Skills, Abilities and Requirements:
BS degree (minimum) or higher (MS or Ph.
D.
preferred) in the Engineering Sciences (ie, Chemical, Mechanical, Electrical, Physics, etc.
) Minimum 5
years' experience in a regulated medical manufacturing environment (7+years preferred) Knowledge of production unit operations and test systems Failure mode effects analysis experience for root cause analysis Six Sigma/Lean principles experience (green belt, with black belt preferred) Proficient in minitab and Microsoft office suite Direct experience with regulated environments (ie, ISO 13485, 21 CFR 820, Notified Bodies, GMP, OSHA, EPA) required.
Estimated Salary: $20 to $28 per hour based on qualifications.
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