Senior Manufacturing Engineer-Medical Device

Job Summary:

An industry-leading healthcare manufacturing organization is seeking a skilled Senior Manufacturing Engineer to support onsite production engineering operations. This role will focus on designing, developing, and optimizing manufacturing processes, tooling, and fixtures to meet production demands while improving efficiency, throughput, and product quality. The position will also lead equipment and process improvement projects, support new product introductions, and collaborate across engineering, quality, packaging, and operations teams in a regulated environment.

Key Responsibilities:

• Design, develop, and enhance manufacturing processes, tooling, fixtures, and production methods to support daily manufacturing schedules

• Lead engineering projects involving new production equipment installation, process optimization, and cost reduction initiatives

• Drive continuous improvement efforts to improve product quality, labor efficiency, and manufacturing throughput using Lean Manufacturing principles

• Conduct Process Failure Mode and Effects Analysis and support process validation activities for new and existing manufacturing lines

• Coordinate the design, procurement, build, testing, and debugging of tooling, machinery, and test equipment

• Partner with product development teams to ensure Design for Manufacturability during new product launch and transfer activities

• Provide technical mentorship and day-to-day guidance to engineers, technicians, and manufacturing support personnel

• Troubleshoot manufacturing issues, identify root causes, and implement corrective engineering solutions

• Collaborate cross-functionally with quality, packaging, operations, and supply chain teams to ensure compliant and efficient production support

• Support divisional initiatives in accordance with Quality Management Systems, environmental standards, and regulatory manufacturing requirements

Required Qualifications:

• Bachelor’s degree in Engineering or related technical discipline

• Minimum 3 years to 5 years of experience in Manufacturing Engineering, Quality Engineering, or Packaging Engineering

• Strong hands-on experience with manufacturing process development, equipment implementation, and tooling improvements

• Working knowledge of Process Validation, Process Failure Mode and Effects Analysis, and root cause problem-solving methodologies

• Experience working in a regulated manufacturing environment such as medical device, pharmaceutical, healthcare, or other highly controlled industries

• Knowledge of Lean Manufacturing and continuous improvement methodologies

• Strong project coordination, organizational, communication, and cross-functional collaboration skills

• Ability to work independently with minimal supervision in a fast-paced production setting

Preferred Qualifications:

• Exposure to Six Sigma tools, concepts, or certification

• Prior experience supporting packaging operations or quality-focused manufacturing programs

• Experience with new product introduction and manufacturing transfer projects

• Demonstrated technical leadership or mentoring capability

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually, as applicable.

Pay Range: $40/hr to $50/hr