Senior Manufacturing Engineer We are seeking a Senior Manufacturing Engineer to provide technical leadership and process ownership within a regulated manufacturing environment. This position will be responsible for developing, validating, implementing, and optimizing manufacturing processes to support product quality, equipment reliability, production capacity, throughput, yield, and continuous improvement. The ideal candidate has experience supporting medical device manufacturing operations and a strong understanding of manufacturing process validation, equipment qualification, statistical analysis, and process control.

Responsibilities:

Serve as a technical process owner for manufacturing operations, equipment performance, process validation, and continuous improvement. Develop, validate, implement, and optimize manufacturing processes supporting commercial production. Design manufacturing processes, procedures, and production layouts for semi-automated equipment, processing, and material handling. Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols. Support test method development and validation activities. Evaluate manufacturing equipment, machinery, and tooling performance and initiate corrective actions when deficiencies are identified. Develop and maintain manufacturing process specifications, work instructions, validation documentation, and other controlled engineering documents. Support manufacturing automation initiatives and advanced manufacturing technologies. Serve as a technical escalation point for complex manufacturing, equipment, process, and quality issues. Lead root cause investigations using structured problem-solving techniques such as 5 Why, Fishbone Analysis, and statistical analysis. Lead continuous improvement initiatives focused on increasing yield and throughput while reducing scrap and improving labor utilization. Partner with equipment suppliers, engineering teams, Quality, Operations, and other stakeholders to improve equipment capability and reliability. Support manufacturing capacity expansion and commercial production ramp-up. Identify and address manufacturing bottlenecks affecting production performance. Provide engineering guidance regarding equipment, manufacturing techniques, design concepts, and specification requirements. Ensure manufacturing processes and procedures comply with applicable FDA Quality System Regulations, ISO 13485 requirements, and company procedures.

Qualifications:

Professional experience supporting manufacturing engineering or manufacturing process development in a regulated environment. Experience supporting medical device manufacturing operations . Demonstrated experience with the development, validation, implementation, and optimization of manufacturing processes . Experience with manufacturing process validation and equipment qualification . Experience developing or executing IQ, OQ, and PQ protocols. Knowledge of statistical analysis, process control, and structured root cause investigation methodologies. Experience troubleshooting manufacturing processes and equipment and implementing corrective actions. Experience supporting continuous improvement initiatives involving yield, scrap, throughput, equipment reliability, or manufacturing efficiency. Ability to work effectively with cross-functional engineering, quality, operations, supplier, and manufacturing teams. Experience developing and maintaining manufacturing documentation in a regulated environment. Knowledge of FDA-regulated quality systems and

ISO 13485.

Preferred Technical Skills:

Experience with one or more of the following is beneficial: Minitab SAP MES AutoCAD SolidWorks Microsoft Office Electronic document management systems Manufacturing automation and semi-automated production equipment

Work Environment:

This position works closely with manufacturing operations and cross-functional technical teams and may require hands-on support of production processes, equipment, validation activities, troubleshooting, and continuous improvement initiatives. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPA Pay:

$55.00 - $80.00 per hour Expected hours: No less than 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Vision insurance People with a criminal record are encouraged to apply

Work Location:

In person