Machine Shop Manufacturing Engineer III

Roles and Responsibilities The Manufacturing Engineer III is a senior-level engineering role responsible for leading complex manufacturing projects, mentoring junior engineers, and driving process innovation across our medical operations. This role plays a critical part in ensuring operational excellence, supporting new product introductions (NPIs), improving manufacturing efficiency, and upholding regulatory compliance. The Engineer III acts as a technical lead, cross-functional collaborator, and subject matter expert for manufacturing processes and continuous improvement. Responsibilities Lead complex process development and optimization projects from concept through implementation. Provide expert-level support for troubleshooting and improving CNC machining, Additive Manufacturing, finishing, assembly, and cleanroom processes. Design and implement robust tooling, gages, and fixturing solutions for new and legacy products. Own manufacturing engineering support for new product introductions (NPI/NPDs), including design transfer, prototyping, manufacturing, and validation. Drive cost reduction, scrap reduction, and process yield improvement initiatives across departments. Collaborate with cross-functional teams to influence product design for manufacturability (DFM). Oversee and execute process validations (IQ/OQ/PQ), equipment qualifications, and protocol development. Support internal and external audits by preparing documentation and demonstrating process controls. Develop and revise SOPs, work instructions, process flow maps, and risk analysis documentation (e.g., PFMEAs). Act as project lead or SME on cross-functional teams involving Quality, Regulatory, Production, and Supply Chain. Assist in vendor evaluation, equipment specification, and implementation of new manufacturing technology. Mentor and train Manufacturing Engineers I and II; provide guidance on best practices and problem-solving. Serve as backup for the Engineering Manager in project updates, team coordination, or customer facing meetings. Requirements Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline. 6+ years of manufacturing engineering experience, preferably in medical devices or a regulated industry. Advanced knowledge of machining processes (CNC milling, Swiss turning, EDM) and their optimization; additive manufacturing experience a plus. Expert-level proficiency in SolidWorks or equivalent CAD software and capable of leading tooling design. Proven experience with DFM, GD&T, root cause analysis, DOE, and Lean/Six Sigma methodologies. Strong knowledge of QMS systems (ISO 13485, 21 CFR 820) and regulatory expectations for process control. Demonstrated success leading cross-functional projects and mentoring engineers or technicians. Excellent verbal and written communication, technical documentation, and presentation skills. Strong organizational, analytical, and project management skills. Experience using ERP and PLM systems (Macola, Exact, or equivalent preferred). Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Ability to stand, walk, climb, crouch, push, pull, and lift occasionally (up to 50 lbs). Regular use of hands and eyes for computer-based design and documentation tasks. Occasionally required to work in a manufacturing environment, exposed to noise, fumes, and moving machinery.

Pay:

$85,000.00 - $100,000.00 per year

Benefits:

401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Experience:

high volume machine shop manufacturing: 6 years (Required) troubleshooting and improving CNC machining: 4 years (Required)

FMEA:

3 years (Required) Manufacturing engineering: 6 years (Preferred)

License/Certification:

Lean Six Sigma Certification or an equivalent (Required)

Location:

Fenton, MO 63026 (Preferred)

Work Location:

In person